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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-99.0, Total Atherosclerotic Occlusion of Radial Artery Patients referred for cardiac catheterization. - Absence of informed consent. 2: Known allergy to nitroglycerin. 3: Ad-hoc PCI 4: Previous ipsilateral TRA. 5: Warfarin or NOAC therapy. 6: Systolic blood pressure < 100 mmHg. 7: Critical aortic stenosis (AVA < 0.6 sq.cm) 8: Inability to administer unfractionated heparin. 9: Need for post-procedural use of heparin (UFH, LMWH) 10: Raynaud's disease. 11: Sheathless technique or use of > 11 cm sheath. 12: History of intractable headache of any cause OR Migraine headache
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-85.0, Inherited Cardiac Arrythmias Long QT Syndrome (LQTS) Brugada Syndrome (BrS) Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Early Repolarization Syndrome (ERS) Arrhythmogenic Cardiomyopathy (AC, ARVD/C) Hypertrophic Cardiomyopathy (HCM) Dilated Cardiomyopathy (DCM) Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy) Normal Control Subjects All patients and family members 18 years of age or older with inherited cardiac arrhythmias including LQTS, Brugada Syndrome (BrS), cathecholaminergic polymorphic ventricular tachycardia (CPVT) or early repolarization syndrome (ERS) are eligible for enrollment All enrolled patients will have undergone clinically indicated genetic testing Age <18 years >85 years pregnant women life-limiting co-morbidities immunocompromise
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.308-0.5, Urethral Obstruction Fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis Oligohydramnios or Anhydramnios after 18 weeks "Favorable urine analysis after 18 weeks (urinary sodium is < 100mEq/L, chloride < 90mEq/L, osmolarity <200mOsm/L and β2-microglobulin <6mg/L 7) Absence of chromosomal abnormalities and associated anomalies (Normal karyotype by invasive testing (amniocentesis or CVS)) Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks Fetal anomaly unrelated to LUTO Congenital cardiac anomaly Increased risk for preterm labor including short cervical length (<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth Placental abnormalities (previa, abruption, accreta) known at time of enrollment A body-mass index ≥ 35 Contraindications to surgery including previous hysterotomy in active uterine segment Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment Maternal medical condition that is a contraindication to surgery or anesthesia
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 20.0-999.0, Biliary Strictures Clinically suspicious biliary stricture that required tissue sampling as medically indicated were considered for the study Biliary stricture caused by extra-luminal compression, such as pancreatic cancer and lymphadenopathy Contraindication for ERCP study Age younger than 20 years Prior tissue sampling had yielded a diagnosis of malignancy A guidewire could not be passed through the stricture Less than 6-month follow-up was available for patients with negative tissue sampling
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Abdominal Aortic Aneurysms Diagnosed abdominal aortic aneurysm with indication for endovascular repair. 2. Intention to electively implant the Aorfix™ Stent Graft System Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU). 2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site. 3. Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure. 4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 20.0-85.0, Prostate Neoplasm Prostatectomy Surgical Procedures, Robotic Urinary Incontinence Biofeedback Pelvic Floor Exercise Prostate cancer patients who underwent robotic radical prostatectomy Neurovascular saving at least one side Bladder neck reconstruction at prostatectomy Posterior reconstruction at prostatectomy Patients who have post-prostatectomy incontinence after Foley catheter removal Patients who have not post-prostatectomy incontinence after Foley catheter removal Neurological deficits Anatomic deformities of pelvic bone Pelvic irradiation history History of other major urological procedures Complications influencing urinary incontinence
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Lower Urinary Tract Symptoms Men and women presenting for new patient visits for evaluation or treatment of LUTS to one of the LURN physicians. 2. Age ≥ 18 years. 3. The presence of any of the symptoms reported in Table 1, based on responses to the LUTS Tool with a one month recall period. 4. The ability to give informed consent and complete self-reported questionnaires electronically. Table 1: LUTS Appropriate for Study Daytime frequency Nocturia Urgency Incontinence/leakage (various types) Poor or absent sensation of bladder filling Slow/weak stream Splitting or spraying Intermittent stream/Double voiding Hesitancy Gross hematuria. 2. Significant neurologic disease or injury, including but not limited to: cerebral vascular accident with residual defect, Alzheimer's dementia, Parkinson's disease, traumatic brain injury, spinal cord injury, complicated spinal surgery, multiple sclerosis. 3. Primary complaint is pelvic pain. 4. Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchialgia. 5. Pelvic or endoscopic GU surgery within the preceding 6 months (not including diagnostic cystoscopy). 6. Current sexually transmitted infection. (deferral; subject can enroll after negative culture) 7. Ongoing symptomatic urethral stricture. 8. History of lower urinary tract or pelvic malignancy. 9. Current chemotherapy or other cancer therapy. 10. Pelvic device or implant complication (e.g., sling or mesh complications). 11. Current functioning neurostimulator. 12. Botox injection to the bladder or pelvic structures within the preceding 12 months. 13. In men, prostate biopsy in the previous 3 months. 14. In women, pregnancy. 15. History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy. 16. Augmentation cystoplasty or cystectomy. 17. Presence of urinary tract fistula. 18. Current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g., dementia, psychosis, etc.). 19. Inability to relay valid information, actively participate in the study, or provide informed consent (includes uncontrolled psychiatric disease). 20. Difficulty reading or communicating in English
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Retention Urinary Tract Infections English-speaking Able to provide informed consent Scheduled to undergo an elective, complex intra-abdominal operation with a planned postoperative inpatient stay of at least 1 night Less than age 18 Allergy or contraindication to tamsulosin Serious sulfa allergy Current use of alpha blocker (alfuzosin, doxazosin, prazosin, silodosin, terazosin, verapamil, tamsulosin) or oral alpha agonist (midodrine), or initiation of one of these medications during the intervention phase of the study will result in subject withdrawal from the study Current warfarin use Pre-existing indwelling urinary catheter, suprapubic catheter, or urostomy End stage renal disease or dialysis-dependence Sitting systolic blood pressure in the upper extremity of less than 100mm Hg at time of screening Presence of orthostatic hypotension at the time of screening (orthostatic hypotension is defined as a drop in systolic blood pressure of 20mm Hg from sitting to standing, or drop in diastolic BP of 10 mm Hg from sitting to standing after 2-3 minutes of standing after being in a sitting position) Anticipated inability to take oral medications on post-operative day #0
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Bladder Papillary Urothelial Carcinoma Stage 0a Bladder Urothelial Carcinoma Stage 0is Bladder Urothelial Carcinoma Stage I Bladder Cancer With Carcinoma In Situ Stage I Bladder Urothelial Carcinoma Stage II Bladder Urothelial Carcinoma Stage III Bladder Urothelial Carcinoma Stage IV Bladder Urothelial Carcinoma Patients with a confirmed diagnosis of UCC, having one of the stages (Ta, Tis, T1, and T2 or higher) Patients with UCC who are undergoing a standard procedure to remove cells/tissue from their bladders (cystoscopy, biopsy, or surgery) Ability to understand and the willingness to sign a written informed consent Patients who have had chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-80.0, Anterior Myocardial Infarction Heart Failure Population Adult male or female patients aged < 80 years with acute myocardial infarction undergoing successful primary or rescue percutaneous recanalization of the infarct-related coronary artery, defined as TIMI 3 flow and residual stenosis <20%) within 24 hours of symptom onset and Left Ventricular Ejection Fraction (LVEF) ≤ 45% at 3-6 after revascularization, as documented by a two-dimensional echocardiogram. 1. Signed and dated informed consent 2. Men and women of any ethnic origin aged ≥ 18 years 3. Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI. 4. Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow ≥2) within 24 hours of symptom onset by successful percutaneous coronary intervention (PCI) or thrombolysis within 12 hours of symptom onset followed by successful PCI within 24 hours after thrombolysis 5. Left ventricular ejection fraction ≤ 45% at 24 hours after revascularization, as documented by a two-dimensional echocardiogram Participation in another clinical trial within 30 days prior to randomisation 2. Pregnant or nursing women or women in childbearing age not able to esclude the possibility of a pregnancy 3. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol 4. Necessity to revascularise additional vessels, outside the target coronary artery after investigational therapy/placebo administration (additional revascularisations after primary PCI and before investigational therapy/placebo administration are allowed) 5. Persistent cardiogenic shock 6. Known hematologic and neoplastic diseases 7. Severe impaired renal function, i.e. GFR<30 ml/min 8. Persistent fever or diarrhoea not responsive to treatment within 4 weeks prior screening or severe infection 9. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg) 10. Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-80.0, Benign Prostatic Hyperplasia (BPH) Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction Age from 45 to 80 years Subject has medical record documentation of a prostate volume between 30mL and 80mL (inclusive) by transrectal ultrasound (TRUS). (If TRUS testing documentation is available from less than 180 days prior to the informed consent date and the prostate volume is between 30mL and 80mL, it may be used for the inclusion/ Subject has an International Prostate Symptom Score (IPSS) score greater than or equal to 12 measured at the baseline visit Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15mL/s. (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 125mL, and the Qmax is less than 15mL/s it may be used for the inclusion/ Subject has a serum creatinine that is within the normal range for the laboratory at the study center (or documentation of clinical insignificance in the subject's medical record by the investigator if outside the normal range) and measured ≤ 30 days prior to the date of surgery History of inadequate response, contraindication, or refusal to medical therapy Body Mass Index (BMI) ≥ 42 History of prostate cancer or current/suspected bladder cancer Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds Subjects with a history of actively treated bladder cancer within the past two (2) years Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size) Active infection, including urinary tract infection
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 51.0-999.0, Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Patient has received a diagnosis of BPH with moderate to severe LUTS, as determined by IPSS Patient is greater than 50 years of age Patient has had a pelvic examination within the past 6 months Patient has been refractory to medical therapy for the last 6 months, or has refused medical therapy Patient has a Qmax below 15 mL/s or acute urinary retention Prostate is larger than 40 cubic centimetres Patient is willing and able to provide written, informed consent Known malignancy Serum PSA > 10 ng/mL at screening Advanced atherosclerosis and tortuosity of the iliac arteries Prior transurethral resection of the prostate (TURP) Post void retention (PVR) > 250 mL Chronic use of metronidizole Phytotherapy for BPH within last two weeks of screening visit Secondary renal insufficiency due to prostatic obstruction Chronic renal failure (GSR < 60) Large bladder diverticula or bladder stones
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-80.0, Benign Prostatic Hypertrophy Having an indication due to BPH Aged between 40 and 80 years old Kidney failure due to BPH Any kind of coagulopathy or use of anticoagulants in the preoperative period History of any previous open or endoscopic prostate surgery
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Cystic Fibrosis Patient with Cystic Fibrosis (bronchiectasis with presence of two mutations in the CFTR gene and / or positive sweat test Patients aged 18 year or older Pre-bronchodilator FEV1 FEV1 ≤ 60% from theoretical value: this FEV1 limits is proposed following the results from our published study (Martin et al. 2013) showing that desaturation during 6MWT and a distance ≤ 475m performed, are almost exclusively found in patients with FEV1 ≤ 60% Stable health status ( >15 days after the start of treatment of a respiratory exacerbation No indications against the walking test: Left uncontrolled heart failure Severe aortic stenosis acute endocarditis syncope Symptomatic severe arrhythmia stable angina Myocardial infarction <5 days Acute respiratory distress Resting SpO2≤85% pulmonary edema Uncontrolled asthma Arterial or venous thrombosis of the lower limbs, Severe acute condition that may interfere with the exercise performance (infections, renal failure, hyperthyroidism, unable to cooperate, severe pulmonary arterial hypertension, severe systemic blood pressure (Systolic blood pressure >200 mm Hg and / or diastolic blood pressure >120 mm Hg)) History of lung transplant Oxygen Dependence (inability to achieve a 6-minute walk test in ambient air) Any indication against walk test Pregnant women, persons deprived of liberty, person under guardianship, person in emergency situation Person not affiliated to social security system Refusal to participate in the study
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-85.0, Urethral Stricture Strictures must predominantly the proximal and/or mid bulbar urethra and be otherwise amenable to buccal graft onlay urethroplasty Strictures may extend from the mid-bulbar urethra up to the distal bulbar urethra within the scrotum, but not through the scrotum to the pendulous junction Subjects able to consent for themselves prior open urethral surgery, such as prior urethroplasty, artificial urinary sphincter placement, male urethral sling placement, and rectourethral fistula radiation therapy to the pelvis previous hypospadias repair lichen sclerosis unable to consent for themselves
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 21.0-999.0, Acute Kidney Injury age ≥ 21 (per manufacturer's instructions on the Nephrocheck kit) history of hypertension, whether medically treated or untreated scheduled for Anesthesia preoperative clinic visit scheduled to undergo prolonged intra-abdominal or intra-thoracic surgeries (defined as scheduled intraoperative time ≥ 4h). Intra-abdominal surgeries will colorectal surgery, massive ventral hernia repairs, hepatobiliary surgery and gynecologic-oncology surgery. Intra-thoracic surgeries will video-assisted thoracoscopic surgery (VATS)-assisted segmentectomy and lobectomies, as well as mediastinal mass excisions will be anticipated to be admitted to the ICU for a minimum of 2-3 days post-operatively history of chronic kidney as defined by estimated glomerular filtration rate (GFR) <90 patient taking NSAIDs on a daily basis patients with a reported allergy or intolerance to NSAIDs
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Stress Incontinence All patients undergoing an AUS procedure would potentially be candidates for the study There are several situations in which either a TC or ST procedure would be specifically indicated, and it would be unethical to randomize these patients to the other procedure No men without erectile dysfunction No use of injectable agents into the corporal body No prior urethral surgery (Prior surgery defined as; urethroplasty, urethral sling, prior AUS placement or explantation, recto-urethral fistula closure) No current penile prosthesis No concomitant placement of penile prosthesis at the time of AUS placement Males under the age of 18, as well as females, are also excluded
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-65.0, Obesity Bariatric Surgery Candidate Obese patients with a body mass index equal or greater than 35 kg/m2 American Society of Anesthesiologists (ASA) II-III Patients scheduled for laparoscopic bariatric surgery under general anesthesia History of significant cardiac disease History of significant respiratory disease History of significant hepatic disease History of significant renal diseases History of an atrio-ventricular block grade II to III Long QT syndrome Pre-existing disorder of the gastrointestinal tract Patients with history of alcohol or drug abuse Allergy to amide local anesthetics History of epilepsy
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urethral Stricture Male ≥ 18 years old with diagnosis of bulbar urethral stricture by voiding cystourethrogram of known and/or idiopathic etiology Male patients with bulbar urethral stricture > 1 cm in length Strictures must predominantly the proximal and/or mid-bulbar urethra Strictures may extend from the mid-bulbar urethra into the distal bulbar urethra Patients with prior history of open urethral surgery, such as Prior urethroplasty Artificial urniary Sphincter placement Male urethral sling placement Rectourethral fistula Radiation therapy to the abdomen or pelvis Patients with previous hypospadias repair lichen sclerosis no involvement of the pendulous urethra
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Bladder Cancer Recurrence PDD All patients coming for first outpatient flexible cystoscopy 4 month after TURB without subsequent BCG instillations Muscle invasive bladder cancer (MIBC) BCG treatment within the last year
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, Benign Prostatic Hypertrophy Lower Urinary Tract Symptoms Patients selected for this study must meet all of the following Age ≥ 50 years Lower urinary tract symptoms secondary to BPH as defined by IPSS Symptom Index ≥ 12 Maximum Uroflow rate (Qmax) of ≤ 12cc per sec Prostate of ≥ 90 gm as determined by MRI or transrectal ultrasound of the prostate (TRUS) Patients meeting any of the following will be excluded from the study Age less than 50 years Prostate cancer Bladder cancer Severe, life-threatening allergy to iodinated contrast Bilateral internal iliac artery occlusion Causes of obstruction other than BPH such as stricture disease Neurogenic bladder or other causes of bladder atonia Post void residual greater than 250 cc Any contraindication to embolization, including
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 19.0-999.0, Sickle Cell Disease Recipient Age greater than or equal to 19 years Diagnosis of sickle cell disease (HB SS, SC, or SBeta-thal(0)); confirmed by hemoglobin electrophoresis, high-performance liquid chromatography, DNA testing when necessary or both At high risk for disease-related morbidity or mortality, defined by having at least one of the following manifestations (A-E) A: Clinically significant neurologic event (stroke) or any neurological deficit lasting > 24 hours B: History of two or more episodes of acute chest syndrome (ACS) in the 2-year period preceding enrollment despite the institution of supportive care measures including hydroxyurea C: Three or more pain crises per year in the 2-year period preceding referral (required intravenous pain management in the outpatient or inpatient hospital setting) despite the institution of supportive care measures including hydroxyurea D: Administration of regular RBC transfusion therapy, defined as receiving 8 or more transfusions per year for ≥ 1 year to prevent vaso-occlusive clinical complications (i.e. pain, stroke, acute chest syndrome, and priapism) E: Pulmonary hypertension (defined as tricuspid regurgitant jet velocity (TRV) ≥2.5 m/s at baseline (without vaso-occlusive crisis) Any one of the below complications not ameliorated by hydroxyurea at the maximum tolerated dose for at least 6 months Detectable antibody to ABO, Rh, or other red blood cell antigen of their donors Presence of donor specific antibodies detected by donor specific antibody screen (if using product from a haploidentical donor) Karnofsky/Lansky performance score < 60 Evidence of uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms) within one month prior to starting the conditioning regimen. Patients with fever or suspected minor infection should await resolution of symptoms before starting the conditioning regimen Poor cardiac function defined as left ventricular ejection fraction < 40% Poor pulmonary function defined as FEV1 and FVC < 40% predicted or diffusing capacity of the lung for carbon monoxide (DLCO) < 40% (corrected for hemoglobin) Poor liver function defined as direct bilirubin > 2x upper limit of normal for age and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 5 times upper limit of normal Poor kidney function defined by creatinine clearance < 70mL/min HIV-positive Unwillingness to use approved contraception method from time of biologic assignment until discontinuation of all immunosuppressive medications
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Adenocarcinoma of the Oesophagus Adenocarcinoma of the Gastro-oesophageal Junction Adenocarcinoma of the Stomach All Patients Histologically verified inoperable locally advanced or metastatic adenocarcinoma of the oesophagus, oesophago-gastric junction, or stomach Completion of 6 cycles of first-line chemotherapy for locally advanced / metastatic disease (this must have included a platinum and fluoropyrimidine in all cases; HER-2 positive patients must have received trastuzumab alongside chemotherapy) with > stable disease on the end of treatment CT scan. If your patient has received first line therapy, delivered on a two weekly basis e.g. they should have received 8 cycles Disease which, following first-line chemotherapy, remains inoperable and unsuitable for definitive chemoradiotherapy Able to proceed with maintenance treatment within 28 days of the last day of the last cycle of chemotherapy Formalin fixed paraffin embedded (FFPE) blocks of diagnostic tissue available for biomarker analysis Any prior chemotherapy or radiotherapy in the adjuvant setting must have been completed at least 6 months prior to the first occurrence of metastatic disease No prior radiotherapy in the advanced disease setting. Patients receiving palliative radiotherapy to sites of disease that are not measurable may be eligible and should be discussed with the Chief Investigator Male/female patients aged ≥18 years WHO Performance status 0, 1 or 2 All Patients Concurrent enrolment in another clinical trial unless it is an observational (non-interventional) clinical study Tumours of squamous histology Documented brain metastases, central nervous system metastases or leptomeningeal disease Patients who have not recovered from clinically significant effects of any prior surgery, radiotherapy or any other anti-neoplastic therapies. All toxicities must have resolved to grade 1 or less, with the exception of peripheral neuropathy which must be < grade 2 according to NCI CTCAE version 4.0 Any major surgery within 4 weeks prior to the start of study treatment Uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg) Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, symptomatic congestive heart failure, uncontrolled cardiac dysrhythmia, or myocardial infarction within the last 12 months. Patients with any prior history of clinically significant cardiac failure are excluded from study entry History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan Lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Non Small Cell Lung Cancer For in the study subjects should fulfill the following 1. Provision of written informed consent to treatment and companion translational studies prior to any study specific procedures 2. Patients must be > 18 years of age. 3. Affiliation to an health insurance 4. Histological diagnosis of NSCLC 5. Advanced or metastatic disease (stage IIIB/IV) 6. Access to the original tumor biopsy or planning of a fresh tumor biopsy before start the platinium based chemotherapy 7. Chemonaive for NSCLC or patient having received adjuvant chemotherapy at least 2 years before trial enrolment or patient currently receiving his/her first platinum-based chemotherapy for advanced NSCLC (first line or second line only if the first line was an anti-PD-1 or anti-PD-L1 agent monotherapy) 8. No other cancer in the previous 3 years, except cervical cancer or cutaneous cancer 9. Absence of EGFR-sensitising mutation or ALK translocation 10. ECOG Performance Status of 0-1 11. Fit to receive 6 cycles or currently receiving of platinum-based induction chemotherapy 12. At the start of the platinium based induction chemotherapy measurable lesions by v1.1 i.e. at least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10mm in the longest diameter (except lymph nodes that must have short axis ≥ 15mm) with computed tomography (CT), magnetic resonance imaging (MRI) or clinical examination and which is suitable for accurate repeated measurements. 13 is only for patients registered before starting the platinum-based induction chemotherapy: 13. Patients must have normal organ and bone marrow function measured within 14 days prior to administration of the platinum based treatment Haemoglobin ≥ 10.0 g/dL Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN Creatinine clearance > 60mL/min as calculated by Cockroft-Gault formula for cisplatin administration; creatinine clearance >/= 51mL/min by Cockroft-Gault formula for carboplatin administration 14. Evidence of non-childbearing status for women of childbearing potential: negative serum pregnancy test within 14 days of study treatment. Postmenopausal is defined as Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments LH and FSH levels in the post-menopausal range for women under 50 Radiation-induced oophorectomy with last menses >1 year ago
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-80.0, Prostatic Cancer Prostatic Neoplasm Age 40 years or older and willing and able to provide informed consent; 2. Histologically and clinically confirmed localized adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features; 3. Surgical indication for open radical prostatectomy; 4. PSA less than 20 ng/mL; 5. No evidence of metastasis disease; 6. Cleared by the primary medical doctor for surgery; 7. No prior systemic therapy for prostate cancer; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Refuses to give informed consent; 2. Refuses or is unable to have radical prostatectomy; 3. Stage T4; 4. Deemed a poor surgical risk per primary medical doctor; 5. Received prior therapeutic intervention for prostate cancer; 6. Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months; 7. Neurogenic bladder; 8. Urinary incontinence
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 60.0-85.0, Urinary Retention Men aged 60-85 catheterised for urinary retention and booked for outpatient removal of catheter Mobile patients Who cannot consent Residual urine of more then 1 litre Abnormal renal functions Poor manual dexterity Learning difficulties/dementia
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Total Knee Arthroplasty Osteoarthritis Post Operative Pain Control Patients scheduled for primary total knee arthroplasty American Society of Anesthesiologists (ASA) physical status I -III mentally competent and able to give consent for enrollment in the study Patient younger than 18 years old Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3) Revision surgery Impaired kidney functions and patient with coagulopathy Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 3 months prior to the surgery BMI of 40 or more Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 65.0-79.0, Obesity Weight Loss Age 65-79 years BMI=30-40 kg/m2 Confirmation of self-reported mobility disability, as assessed by phone screen/clinical staff Self-reported sedentary behavior Non-impaired cognitive function (MoCA>18) Stability of residence for next 2 years Willing and able to follow dietary protocol Willing to provide informed consent Approved for participation by study physician Not involved in another behavioral or interventional research study Weight loss or gain (±5%) in past 6 months Prior bariatric surgery Multiple food allergies Difficulty with hearing/vision that interferes with study participation Excessive alcohol use (>14 drinks/week) Smoker (>1 cigarette/d within year) Insulin-dependent or uncontrolled diabetes (FBG >140 mg/dl) Uncontrolled hypertension (BP>160/100 mmHg) Abnormal kidney tests (GFR<40, creatinine >2.0) Regular use of medications that may influence body weight or composition
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Distal Radius Fracture Post Operative Pain Control Patients scheduled for open reduction and internal fixation of a distal radius fracture American Society of Anesthesiologists (ASA) physical status I -III Mentally competent and able to give consent for enrollment in the study Patient younger than 18 years old Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone and any of the drugs included in the standard of care Patients opting to go under general anesthesia and those refusing the block Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 6 months prior to the surgery BMI of 40 or more
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-95.0, Vaginal Apical Prolapse Women undergoing vaginal apex surgery (sacrocolpopexy, sacrospinous ligament suspension, uterosacral ligament suspension, colpocleisis) with or without mid-urethral sling, with or without anterior or posterior colporrhaphy Patients who underwent a surgery that requires long term catheterization (i.e fistula repair or urethral diverticulum) 2. Patients who sustained a cystotomy during surgery as our divisional protocol is to send these patients home with a Foley catheter for 5-14 days without a voiding trial 3. Patients with baseline urinary retention and the inability to urinate without catheterization 4. Pregnant women
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, Prostatic Hyperplasia Greater than or equal to (>=) 50 years of age at the time of signing the informed consent form Male Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and protocol Present in a General Practice setting for a reason unrelated to this study Positive IPSS score >=8 and/or positive BPE/BPO screening tool score >=3 History of BPH for which they have received test procedures, medical intervention and/or medicine History of prostate-related LUTS for which they have received test procedures, medical intervention and/or medicine History of prostatic surgery (including transurethral resection of the prostate (TURP), balloon dilatation, thermotherapy, and/or stent replacement) or other invasive or minimally invasive procedures to treat BPH Has other conditions that may cause urinary symptoms (e.g., neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections, etc.) History or evidence of prostate cancer (e.g., positive biopsy or ultrasound, suspicious DRE and/or rising PSA) Current or prior use of the following: 5alpha-reductase inhibitors (finasteride or dutasteride); anti-cholinergics (e.g. oxybutynin, propantheline, tolterodine, solifenacin, darifenacin, mirabegron) alpha-adrenoreceptor blockers (i.e., indoramin, prazosin, terazosin, tamsulosin, alfuzosin, doxazosin and silodosin), herbal products for urinary symptoms; Use of any investigational study drug within 30 days or 5 half-lives of the drug in question, (whichever is longer), preceding the first study visit Use within previous 30 days at Visit 1 of: phosphodiesterase type 5 inhibitor (PDE-5) inhibitors for erectile dysfunction; anabolic steroids
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Catheters Catheterization, Peripheral Adult ED patient requiring an IV for clinical care Hemodynamically stable: pulse >50 and <130, MAP>60 Willing to read (or be read to) the informed consent and participate in study Medically unstable Agitated or psychiatrically unstable Lacking capacity to consent, such as with altered mental status Unable to speak and read English
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Arthroplasty, Replacement, Knee Males and Females 18 years of age or older Undergoing elective primary total knee arthroplasty Patient is willing and able to give consent and participate Inability to receive spinal anesthesia or peripheral nerve block Non-ambulatory patients Non English speaking patients Vulnerable populations including prisoners
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 21.0-80.0, Diabetes Mellitus Study patients should meet the following for in the study: 1. 100 Chinese, 100 Malays, 100 Indian patients with DM2 2. Age 21-80 years 3. Able to give informed consent 4. Stable diabetes, blood pressure and hyperlipidaemia medications (a 25% dose adjustment is allowed) in the last three months 5. For to be randomized: HbA1c should be 10% inclusive or below at time of randomisation 6. Blood Pressure should be less than 180/120 mm Hg at time of recruitment 7. Non-smokers or discontinued smoking at least 6 months ago 8. No h/o previous myocardial infarction, previous cerebrovascular accident inclusive of haemorrhage and infarction, or h/o of peripheral amputation or bypass procedures Inability to give informed consent 2. Pregnant subjects 3. Patients hospitalized for any condition less than 1 month from enrolment 4. Patients having any recent infections or symptoms suggestive of any systemic infection in the last 2 weeks 5. Myocardial Infarction or stroke within 6 months before enrolment 6. Patients with creatinine concentrations >200 µmol/L or eGFR<30 µmol/L 7. Patients on anticoagulants such as warfarin 8. Known allergy to vitamin E 9. Current smokers 10. h/o previous myocardial infarction, previous cerebrovascular accident inclusive of haemorrhage and infarction, or h/o of peripheral amputation or bypass procedures 11. Patients on immunosuppressive agents or corticosteroids for other conditions 12. Presence of concomitant malignancies or rheumatological conditions at the time of recruitment 13. Patients taking orlistat & cholestyramine
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Bile Duct Strictures Common Bile Duct Stones All patients referred for the evaluation of indeterminate strictures or removal of difficult stones All patients who are unable or unwilling to give consent will not be included in this study
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urologic Neoplasms Recurrent or metastatic urothelial cancer Patients must have failed prior platinum based treatment (adjuvant or 1st line) Archival tissue sample available for biomarker testing at pre-screening and tissue banking Patients should complete a pre-screening biomarker analysis and should fulfill the following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should show EGFR (Epidermal Growth Factor Receptor) amplification Further apply Prior use of EGFR, ERBB2 or ERBB3 targeted treatment Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis Further apply
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 8.0-999.0, Domestic Violence Mental Health Impairment Child Abuse Alcoholism Families living in the study compounds in Lusaka (i.e., not staying temporarily) 2. Speaking one of the three study languages: English, Bemba, or Nyanja 3. Having at least one male adult and one female adult 18 years of age or older and in a relationship (married or dating) and one child between the ages of 8 to 17 identified by the mother as the most affected by the violence (if multiple children in the home). Child participation is optional. 4. The man and woman must both provide consent. If the female agree to have the child participate and the child wants to participate, then parental permission and child assent will be required. 5. The adult female must indicate during the screening at least a moderate amount of violence within the family as measured by scoring a 38 or more on the Severity of Violence Against Women Scale (SVAWS). 6. The male in the family must indicate that he drinks alcohol at hazardous levels or the female must report that the male drinks alcohol at hazardous levels as evidenced by scoring an 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT) Any of the family members is currently on an unstable psychiatric drug regimen (i.e., regimen altered in last 2 months) 2. Any of the family members has had a suicide attempt or suicidal ideation with intent or plan, or self-harm in the past month. 3. Any of the family members has been diagnosed with a current psychotic disorder (identified by the University Teaching Hospital Psychiatric Unit). 4. Any of the family members has a serious developmental disorder (e.g., mental retardation, autism) that would preclude participation in cognitive-behavioral oriented skills intervention
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Complications; Catheter, Urinary Infection or Inflammation Adult patients (≥18 years) Patients with permanent suprapubic urethral catheter (Foley catheter) of latex or silicone At least 3 documented CAUTI infections during last year Spinal Cord Injured, changing catheters at Rehab Station every 10 weeks (+/ weeks) Children (˂18 years) Participating in other clinical trial(s) with exposure/treatment that could affect the outcome of the present study Stones (calculi) in the urinary tract (these patients can be included after the stones have been removed) Patients on antibiotic treatment (these patients can be included after the treatment is completed (+10 days of expectance))
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Prostate Cancer Minimum age of 18 Years Voluntarily agreement to participate in this study filled in and signed Informed Consent release of medical records for regulatory or research purposes clinically organ-confined prostate cancer recommended and planned robot-assisted radical prostatectomy Participation in other interventional trials that could interfere with the present study International Prostate Symptom Score (IPPS) > 18 History of radiation or chemotherapy History of transurethral prostate resection unable to provide informed consent unwillingness to storage and forwarding of pseudonymous data
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 20.0-999.0, Urinary Bladder, Overactive Aged >=20 years at the time of signing the informed consent Subject has symptoms of OAB (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening, determined by documented subject history Subject has not been adequately managed with one or more medications (that is, anticholinergics or beta-3 adrenergic receptor agonist) for treatment of their OAB symptom. 'Not adequately managed' is defined as: An inadequate response after at least a 4-week period of OAB medication(s) on an approved optimized dose(s), that is, subject is still incontinent despite medication(s) for OAB; or limiting side effects (that is, condition that subject reduced dosage or discontinued the medication due to side effect after at least a 2-week period of OAB medication(s) on an approved optimized dose(s)) Subject who experiences all of the following, in the 3-day subject bladder diary completed during the screening phase: 1. >= 3 episodes of urinary urgency incontinence, with no more than one urgency incontinence-free day 2. urinary frequency (defined as an average of >= 8 micturitions [toilet voids] per day, that is, a total of >= 24 micturitions) Subject is willing to use clean intermittent catheterization (CIC) to drain urine if it is determined to be necessary by the investigator (or subinvestigator) Body weight >=40 kilograms (kg) at screening Males or females: 1. Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until the study exit Vasectomy with documentation of azoospermia Male condom plus partner use of one of the contraceptive options below: Intrauterine device or intrauterine system that meets the standard operating procedure (SOP) effectiveness including a <1% rate of failure per year, as stated in the product label; or oral contraceptive, either combined or progestogen alone. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. 2. Female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine or serum human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: • Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. • Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until the study exit. This list of highly effective methods (approved in Japan) is provided below, and it does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis: Intrauterine device or intrauterine system that meets the SOP effectiveness including a <1% rate of failure per year, as stated in the product label; Oral Contraceptive, either combined or progestogen alone; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception Subject has given signed informed consent, including compliance with the requirements and restrictions listed in the consent form and in this protocol (example, using the toilet without assistance, complete bladder diaries and questionnaires, is able to collect volume voided per micturition measurements over a 24-hour period, and attend all study visits in the opinion of the investigator (or subinvestigator) Subject has symptoms of OAB due to any known neurological reason (example, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.) Subject has a predominance of stress incontinence determined by subject history Subject has a history or evidence of any diseases, functional abnormalities or bladder surgery, other than OAB, that may have affected bladder function including but not limited to: 1. Bladder stones (including bladder stone surgery) within 6 months prior to screening or confirmed occurrence of bladder stones at the screening phase 2. Surgery (including minimally invasive surgery) within 1 year of screening for stress incontinence or pelvic organ prolapse 3. Current use of an electrostimulation/neuromodulation device for treatment of urinary incontinence. Note: Use of any implantable device is prohibited within 4 weeks prior to initiation of screening phase and throughout the study period. Use of any external device is prohibited within 7 days prior to the start of the screening phase 4. History of interstitial cystitis, in the opinion of the investigator (or subinvestigator) 5. Past or current evidence of hematuria due to urological/renal pathology or uninvestigated hematuria. Subjects with investigated hematuria may enter the study if urological/renal pathology has been ruled out to the satisfaction by the investigator (or subinvestigator). 6. Past or current history of bladder cancer or other urothelial malignancy, positive result of urine cytology or uninvestigated suspicious urine cytology results at the Screening phase. Suspicious urine cytology abnormalities require that bladder cancer or other urothelial malignancy has been ruled out to the satisfaction of the investigator according to local site practice. 7. An active genital infection, other than genital warts, either concurrently or within 4 weeks prior to Screening 8. Male with previous or current diagnosis of prostate cancer or a prostate specific antigen (PSA) level of >10 nanograms (ng)/mL at Screening. Subjects with a PSA level of >= 4 ng/mL but <= 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator (or subinvestigator) according to local site practice. 9. Evidence of urethral and/or bladder outlet obstruction, in the opinion of the investigator (or subinvestigator) Subject has a history of 2 or more urinary tract infections (UTIs) within 6 months of initiation of Treatment phase 1 (Week 0) or current administration of prophylactic antibiotics to prevent chronic UTIs Subject has a positive urine dipstick reagent strip test at initiation of Treatment phase 1 (Week 0) for nitrites or leukocyte esterase, or who are considered by the investigator (or subinvestigator) to have UTI Subject has a serum creatinine level >2 times the upper limit of normal (ULN) at screening Alanine aminotransferase (ALT) > 2xULN; and bilirubin > 1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at screening Subject has current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). Notes: 1. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis 2. Chronic stable hepatitis B and C (example, presence of hepatitis B surface antigen [HBsAg] or positive hepatitis C antibody [HCVAb] test result within 3 months prior to first dose of study treatment) are acceptable if subject otherwise meets entry QT corrected (QTc) > 450 milliseconds (msec) or QTc > 480 msec in subjects with Bundle Branch Block from the result of electrocardiogram (ECG) at screening. Notes: 1. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read 2. The specific formula that will be used to determine and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to or discontinue the subject from the trial Subject has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diathesis
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-80.0, Benign Prostate Hyperplasia Age between 50 and 80 years old. 2. Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) ≥13, despite medical treatment with alpha-blockers for at least 6 months, or 3. Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) ≥13, for whom medication is contraindicated, not tolerated or refused, or 4. Patients with history of acute retention of urine with or without previous treatment with Alpha-blockers. 5. Patients with QOL score ≥3. 6. Patients with Urine flow rate < 15ml/second or acute urinary retention. 7. Patients with evidence of prostatic enlargement determined by digital rectal examination or ultrasonography (USG), with a prostate size of not less than 40 grams Active urinary tract infection 2. Biopsy proven prostate or bladder cancer, or any recent cancer within 5 years other than basal or squamous cell skin cancer 3. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease, spinal cord injuries, etc) 4. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition 5. Prostate size <40 grams on CT or MRI 6. Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate 7. Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis. 8. Unable to have MRI imaging (e.g. metal implant including pacemaker, replacement joint, etc) 9. Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months 10. Baseline serum creatinine level > 160 umol/L 11. Known upper tract renal disease 12. Cystolithiasis or chronic hematuria within 3 months prior to study treatment 13. Active prostatitis 14. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease 15. History of pelvic irradiation or radical pelvic surgery 16. Coagulation disturbances not normalized by medical treatment 17. Known major iliac arterial occlusive disease 18. Allergy to iodinated contrast agents 19. Hypersensitivity to gelatin products
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 20.0-999.0, Benign Prostatic Hyperplasia Prostate Cancer Admitted to National Cheng Kung University Hospital Urology during the study Older than 20 years old Agree to participate this study Receiving transurethral resection of the prostate for benign prostatic hyperplasia or prostate cancer Poor expression ability and without close care givers to answer questions
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 20.0-999.0, Urinary Bladder, Overactive Aged >=20 years at the time of signing the informed consent Subject has urinary incontinence as a result of neurogenic detrusor overactivity for a period of at least 3 months prior to screening as a result of spinal cord injury or multiple sclerosis, determined by documented subject history. In addition: 1. Spinal cord injury subjects must have a stable neurological injury level C5 or below occurring >=6 months prior to screening. 2. Multiple sclerosis subjects must be clinically stable in the investigator's opinion, for >=3 months prior to screening and have an Expanded Disability Status Scale score <=6.5 Subject has NDO for a period of at least 3 months prior to screening, determined by documented subject history. The presence of an involuntary detrusor contractions (IDC) must also be demonstrated during the urodynamic assessment during the screening period or Day 1 (prior to randomization) Subject has not been adequately managed with one or more medications (i.e., anticholinergics or beta-3 adrenergic receptor agonist) for treatment of urinary incontinence due to NDO . Not adequately managed is defined as: An inadequate response after at least a 4-week period of medication(s) for urinary incontinence due to NDO on an optimized dose(s), i.e., subject is still incontinent despite medication(s) for urinary incontinence due to NDO, or Limiting side effects (i.e., condition that subject reduced dosage or discontinued the medication due to side effect) after at least a 2-week period of medication(s) for urinary incontinence due to NDO on an optimized dose(s) Subject has >=6 episodes of urinary incontinence, with no more than one urgency incontinence-free day in the 3-day subject bladder diary completed during the screening phase Subject currently uses or is willing to use clean intermittent catheterization (CIC) to empty the bladder (indwelling catheter is not permitted). Subjects currently on CIC should be willing to maintain a CIC schedule of at least 3 times per day throughout the study. Caregiver may perform CIC Body weight >=40 kilogram (kg) at screening Males or females： 1. Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until the study exit Vasectomy with documentation of azoospermia Male condom plus partner use of one of following the contraceptive options:Intrauterine device or intrauterine system that meets the standard operating procedure (SOP) effectiveness including a <1% rate of failure per year, as stated in the product label; or oral contraceptive, either combined or progestogen alone These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception 2. Female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine or serum human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: • Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. • Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until the study exit. This list of highly effective methods (approved in Japan) is provided below, and it does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis: Intrauterine device or intrauterine system that meets the SOP effectiveness including a <1% rate of failure per year, as stated in the product label; Oral Contraceptive, either combined or progestogen alone; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception Subject has a history or evidence of any diseases, functional abnormalities or bladder surgery, other than NDO, that may have affected bladder function including but not limited to: 1. Bladder stones (including bladder stone surgery) within 6 months prior to screening or confirmed occurrence of bladder stones at the screening phase 2. Surgery (including minimally invasive surgery) within 1 year of screening for stress incontinence or pelvic organ prolapse 3. Current use of an electrostimulation/neuromodulation device for treatment of urinary incontinence. Note: Use of any implantable device is prohibited within 4 weeks prior to initiation of Screening phase and throughout the study period. Use of any external device is discontinued at least 7 days prior to the start of the screening phase 4. Current use of a baclofen pump 5. History of interstitial cystitis, in the opinion of the investigator (or subinvestigator) 6. Past or current evidence of hematuria due to urological/renal pathology or uninvestigated hematuria. Subjects with investigated hematuria may enter the study if urological/renal pathology has been ruled out to the satisfaction by the investigator (or subinvestigator) 7. Past or current history of bladder cancer or other urothelial malignancy, positive result of urine cytology or uninvestigated suspicious urine cytology results at the Screening phase. Suspicious urine cytology abnormalities require that bladder cancer or other urothelial malignancy has been ruled out to the satisfaction of the investigator according to local site practice. 8. An active genital infection, other than genital warts, either concurrently or within 4 weeks prior to Screening 9. Male with previous or current diagnosis of prostate cancer or a prostate specific antigen (PSA) level of >10 nanogram (ng)/milliliter (mL) at Screening. Subjects with a PSA level of >= 4 ng/mL but <= 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator (or subinvestigator) according to local site practice. 10. Evidence of urethral and/or bladder outlet obstruction, in the opinion of the investigator (or subinvestigator) Subject has a serum creatinine level >2 times the upper limit of normal (ULN) at screening Alanine aminotransferase (ALT) > 2×ULN; and bilirubin > 1.5×ULN (isolated bilirubin >1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at screening Subject has current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). Notes: 1. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice, or cirrhosis 2. Chronic stable hepatitis B and C (example, presence of hepatitis B surface antigen [HBsAg] or positive hepatitis C antibody [HCVAb] test result within 3 months prior to first dose of study treatment) are acceptable if subject otherwise meets entry QTc >450 milliseconds (msec) or QTc >480 msec in subjects with Bundle Branch Block from the result of ECG at screening. Notes: 1. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read 2. The specific formula that will be used to determine and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to or discontinue the subject from the trial Subject has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diathesis Subject changes or initiates or discontinues anticholinergic, beta-3 adrenergic receptor agonist or any other medications or therapies to treat urinary incontinence due to NDO, within 6 days prior to the start of the screening phase Subject has been treated with any intravesical pharmacologic agent (e.g., capsaicin, resiniferatoxin) for urinary incontinence due to NDO within 12 months prior to initiation of Treatment phase 1 (Week 0) Subject has previous or current use of botulinum toxin therapy of any serotype for the treatment of any urological condition Subject has previous use within 12 weeks prior to initiation of Treatment phase 1 (Week 0) or current use of botulinum toxin therapy of any serotype for any non-urological condition or beauty care
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.333-4.0, Hypospadias Age 4 months to 4 years ASA score I and II Primary hypospadias repair in one stage including distal, midshaft, and proximal repairs Age <4 months or >4 years ASA score >II Genetic syndromes Previous hypospadias operations Staged hypospadias repair operations Spinal dysraphism or other contraindications to caudal block Infection at the block site Refusal of consent by the parents Unwillingness of the anesthesiologist or surgeon to participate
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 20.0-80.0, Thyroid Diseases Age 20-80 years old Thyroid diseases, including nodular goiter, hyperthyroidism, hypothyroidism and thyroid cancer (before or after operation), consecutive follow-up in outpatient department, and we expected to enroll 800 patients in one year, and follow-up with observation for 5 years N/A
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Retention Urinary Tract Infections Admission to one of three hospital units at the University of Virginia (5 Central, 6 West, or the Short Stay Unit) Patient has a Foley urethral catheter in place The physician has ordered the Foley urethral catheter to be discontinued Age less than 18 years Prisoners Women who are pregnant
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2
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-80.0, Gallstones Complicated by CBD Stones patients with GB stone complicated with CBD stones accept to share in the study the presence of one or more preoperative predictors for high risk for difficult cholecystectomy patient fit for LC patients< 18 and >80 unfit for surgery didn't accept to share in the study
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Surgery for Sacral Nerve Neurostimulation Surgery for Urinary Artificial Sphincter Surgery for Prosthetic Penile Implant Age > 18 years Healthcare insurance affiliation Surgeries : sacral nerve neurostimulation, urinary artificial sphincter, or prosthetic penile implant ASA (American Society of Anesthesiology) score between I and III Patients that can be accompanied by a person with a car Prior Informed Consent procedure form signed Hospitalisation in Lyon Sud Hospital Refusal of participation or signing the consent form, guardianship or curatorship patients Inability to understand the procedure History of cognitive or psychiatric disorders Non to out patient Pregnant or breastfeeding patients No affiliation to Healthcare insurance
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Bladder Neoplasms Urologic Neoplasms Neoplasms Urinary Bladder Diseases Urologic Diseases Main 1. Single or multiple tumors (n≤7) 2. Recurrent or Naive tumor. 3. No prior history of T1 and/or Tis 4. At least one tumor >1mm. 5. Largest tumor diameter ≤ 30mm 6. Cystoscopic appearance of papillary Low or high grade tumor Main Carcinoma In Situ (CIS) 2. Over 7 lesions 3. Lesion is larger than 30mm in diameter 4. Cystoscopic appearance suspicious for Tis 5. Tumor located in prostatic urethra 6. Previous systemic chemotherapy or pelvic radiotherapy
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Neoplasm, Trophoblastic Gestational Trophoblastic Disease Hydatidiform Mole Hydatidiform Mole, Invasive Patients are eligible if they have a histologically proven trophoblastic disease, or a diagnosis of gestational trophoblastic neoplasia done on an abnormal evolution of hCG none
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 20.0-999.0, Nocturia Written informed consent prior to performance of any trial-related activity Man ≥20 years of age Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1 ≥2 nocturnal voids at the end of screening period prior to Visit 2 Nocturnal polyuria at the end of screening period prior to Visit 2 Bothered by nocturia on the Hsu 5-point Likert bother scale at Visit 1 and Visit 2 Has given agreement about contraception during the trial Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 2 History or evidence of significant obstructive sleep apnoea History or diagnosis of any of the following urological diseases at Visit 1 Interstitial cystitis or bladder pain disorder Suspicion of moderate or severe benign prostate hyperplasia (BPH), defined as international prostate symptom score (IPSS) ≥8 points and Urinary flow <5 mL/s or Post-void residual volume >150 mL Stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on prior history Chronic pelvic pain syndrome Surgical treatment, including transurethral resection, for bladder outlet obstruction (BOO) or BPH within the past 6 months prior to Visit 1
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Abdomino-pelvic Surgery Abdominal-pelvic surgery (digestive, gynecologic, urologic) with laparotomy or laparoscopy Surgery duration superior to 1 hour ASA score of 4 BMI > 35 supraventricular arrythmia (isolated extrasystoles excepted) cardiac insufficiency (F.E < 25 %) severe peripheric vascular affections severe respiratory affections terminal renal insufficiency (creatine clear and < 30 mL/min) gelatin allergies
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Pulmonary Embolism Medical Device Complication Deep Vein Thrombosis Catheter Thrombosis Catheter-related Bloodstream Infection (CRBSI) Nos All consecutive patients in whom the Angel® Catheter is placed, or there has been an attempt to place N/A
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 65.0-999.0, Frail Elderly Exercise Therapy Physical Therapy Techniques volunteers above the age of 65 who are community residents and classified as frail according to the established by Fried et al. will be selected for in the study previous lower extremities orthopedic surgery, a history of fractures within the past year, an inability to walk unaided, carriers of neurological diseases, diagnosed acute inflammatory disease that could interfere in the assessments and the program, tumor growth in the last five years and cognitive impairment based on the mini-mental state examination [4]. Moreover, will be excluded volunteers who are absent more than three consecutive training and / or more than 25% of the sessions, and / or present the course of the physical program changes or decompensation and / or disease injury
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Infection Cancer Male patients of at least 18 years of age Histologically proven rectal adenocarcinoma Stage T1-4 Nx Mx With or without neoadjuvant treatment TME and low anastomosis (colorectal or coloanal, stapled or handsewn) With or without loop ileostomy Open or laparoscopic approach Patient and doctor have signed a study specific informed consent form Colonic and upper third rectal cancer (No or Partial Mesorectal Excision) Abdominoperineal resection Associated prostate, and/or seminal glands and/or bladder resection Infected tumour, Emergency surgery Epidural analgesia Patient with antibiotic therapy (other than prophylaxis) Previous treated/untreated known prostate or bladder carcinoma Patient with symptomatic preoperative voiding dysfunction (IPSS score >19) Medical history of bladder catheterization for obstruction, or urethral surgery Patient necessitating urinary output monitoring (impaired renal function etc)
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-70.0, Heart Failure With Normal Ejection Fraction Preserved left ventricular systolic function on echocardiography (LVEF>50%) Evidence of diastolic dysfunction by echocardiography (E/e'>15) Symptoms of heart failure NT-proBNP levels >300 pg/ml absence of permanent atrial fibrillation acute multi-organ failure history of any malignant disease within 5 years diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity) pregnancy
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Obstruction; Catheter, Infusion Catheter (Vascular) Catheter; Complications (Indwelling Catheter) Able to read and understand English Has a BioFlo implanted port in place less than one (1) year Evidence of a patent BioFlo port catheter prior to enrollment in the study Is receiving active treatment (i.e., receiving a therapeutic drug) through the BioFlo implanted port Current treatment protocol projected to continue for a minimum of three (3) months Anticipates receiving care at the identified centers for 12 months following enrollment in the study Does not receive care of BioFlo implanted port at any other facility Has documented heparin platelet antibody (i.e., could not be randomized to either group) or other allergy to heparin Receiving therapeutic dose of an anticoagulant (e.g.,warfarin, heparin, enoxaparin) Does not meet one or more of the
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia Male, 45 years or older Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia refractory to medical therapy for at least 6 months IPSS score at initial evaluation should be greater than 12, and uroflowmetry (Qmax) of <15mL/s (milliliters per second) All prostate volumes will be > 40gm PSA which meets one of the following criteria:Baseline PSA ≤ 2.5ng/mL, Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required);Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Negative prostate biopsy (minimum 12 cores within 12 months) if abnormal digital rectal examination Patients with active urinary tract infections or recurrent urinary tract infections (> 2/year), prostatitis, or interstitial cystitis Cases of biopsy proven prostate, bladder, or urethral cancer Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy who are unwilling to stop therapy for 2 months prior to the study Use of anithistamines, anti-convulsants, and antispasmodics within one week of treatment unless they have been treated with the same drug (at the same dosage) for at least 6 months and has an associated stable voiding pattern Patients who are classified as New York Heart Association Class III (Moderate), or higher, have cardiac arrhythmias, have uncontrolled diabetes, or are known to be immunosuppressed Hypersensitivity reactions to contrast material not manageable with prophylaxis Patients with glomerular filtration rates less than 40 who are not already on dialysis Prostate volume <40 mL Patients with bilateral internal iliac arterial occlusion Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc)
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-100.0, Intimate Partner Violence Migration background was defined according to current law (MighEV §6, Sozialgesetzbuch) [45]. In detail this means that migration background is fulfilled, if (1) the person does not possesses the national citizenship, or (2) the origin of birth is outside the borders of the national country, and emigration to the national territory was after 1949, or (3) origin of birth of one of the two parents is outside the current borders of the national territory plus emigration of one of the two parents occured after 1949 If other than
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-999.0, Prostatic Hyperplasia Benign Prostatic Hyperplasia Adenoma, Prostatic Prostatic Adenoma Prostatic Hyperplasia, Benign Prostatic Hypertrophy Prostatic Hypertrophy, Benign Rezum Male subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention. 2. IPSS score of ≥ 15. 3. Qmax: Peak flow rate ≤ 15 ml/sec. 4. Post-void residual (PVR) < 300 ml. 5. Prostate transverse diameter > 30 mm. 6. Prostate volume between 20 to 120 gm. 7. Voided volume ≥ 125 mL 8. Subject able to complete the study protocol in the opinion of the investigator. 9. Life expectancy of at least one year History of any illness or surgery that may confound the results of the study or have risk to subject. 2. Presence of a penile implant. 3. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH. 4. Currently enrolled or has been enrolled in another trial in the past 30 days. 5. Confirmed or suspected malignancy of prostate or bladder 6. Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease. 7. Previous pelvic irradiation or radical pelvic surgery. 8. Documented active urinary tract infection by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catherization specimen) 9. Neurogenic bladder or sphincter abnormalities. 10. Urethral strictures, bladder neck contracture or muscle spasms. 11. Bleeding disorder or is currently on coumadin. (Note that use of anti-platelet medication is not an ) 12. Subjects interested in maintaining fertility. 13. Use of concomitant medications to the following: 1. Use of, antihistamines, and antispasmodics within 1 week of treatment unless there is documented evidence stable dosing for last 6 months (no dose changes). 2. Use of alpha blockers, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment. 3. Use of 5-alpha reductase inhibitor within the last 6 months 4. Use of antidepressants, anticholinergics, anticonvulsants, and beta blockers unless there is documented evidence of stable dosing 14. Subject is unable or unwilling to go through the "washout" period prior to treatment. 15. Subject has chronic urinary retention. 16. Post-void residual volume > 300 ml. 17. Significant urge incontinence. 18. Poor detrusor muscle function. 19. Neurological disorders which might affect bladder or sphincter function. 20. Urinary sphincter abnormalities. 21. Bladder stones. 22. Evidence of bacterial prostatitis or symptoms of epididymitis 23. Renal impairment or serum creatinine > 2.0 mg/dl 24. In the physician's opinion, subject cannot tolerate a cystoscopy procedure well. 25. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements. 26. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study. 27. Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum). 28. Biopsy of prostate within 30 days of procedure
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Urolithiasis UTI Age: >=18 years of age Gender: both men and women included. We anticipated enrolling a study population of approximately 60% men and 40% women based on a higher incidence of kidney stones among men in data. Ethnic background: all ethnicities will be included in the study population and the specific ethnic diversity present in the study population will reflect the geographic distributions of the participating institutions. Health Status: see below for specific inclusion/ Patients with indwelling ureteral stents placed within the 2 weeks prior to the procedure visit for removal Patients having underwent kidney stone treatment surgery (shockwave lithotripsy [SWL], ureteroscopy [URS], retrograde intrarenal surgery [RIRS], percutaneous nephrolithotomy [PNL]) Patients with indwelling urethral catheter Patients with indwelling suprapubic catheter Patients with indwelling nephrostomy tube Patients who perform clean intermittent catheterization Pregnancy
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-999.0, Prostatic Hyperplasia males, over forty years, with clinical diagnosis or imaging diagnosis of benign prostate hyperplasia (ultrasonography, computed tomography, magnetic resonance imaging) with stable low urinary tract symptoms and International Prostate Symptom Score lower or equal to 25 points followed at tertiary care clinic low urinary tract symptoms and International Prostate Symptom Score over to 25 points, inadequate clinical treatment response, surgical treatment indication, suspicion of prostate malignancy or urethra stricture or neurogenic bladder and illiterates
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urethral Stricture Males Age ≥ 18 years Failed prior proven conservative measures, including DVIU or balloon dilation of the stricture will be included in this study Able and willing to undergo regular intervention as well as evaluation as described below will be included in the study With a single stricture <2cm in size that can be identified on retrograde urethrogram or voiding cystourethrogram will be included in the study Must agree not to participate in a clinical study involving another investigational drug or device throughout the duration of this study Must be competent to understand the information given in IRB approved ICF and must sign the form prior to the initiation of any study procedure Has not yet undergone proven non-invasive measures, including DVIU or balloon dilation Multiple strictures or a single stricture larger than 2cm in size, measured with retrograde urethrogram or voiding cystourethrogram Age <18 Females Prior urethroplasty Urethral fistula Allergy or sensitivity to CHC Bleeding disorder or anticoagulant use other than aspirin up to 150mg/day Untreated urinary tract infection Inability to perform intermittent self-catheterization
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Hydronephrosis Over 18 years of age Has the mental capacity to provide informed consent for participation within the study Patients who have had anterior lumbar spinal surgery at least 12 months ago and no longer than 5 years ago Unable to understand written or verbal information regarding the study Multiple abdominal surgeries prior to spinal surgery Previous renal complication such as renal strictures or hydronephrosis/use of stents Pregnancy Structural anomalies
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-80.0, Benign Prostatic Hypertrophy With Outflow Obstruction Benign Prostatic Hyperplasia years of age or older Clinically diagnosed with mild to moderate BPH Prostatic volume ≥ 30 ml determined by transrectal ultrasound Maximum flow rate (Qmax) < 15 ml/sec for a voided volume 150-500 ml Participants must not have severe BPH (IPSS symptom score >21) Participants should not be currently undergoing any other form of medical therapy for BPH (5-PDE inhibitors, mepartricine, plant extracts such as Saw Palmetto, vitamin E, and quercetin) Patients must not have undergone prior transurethral resection of the prostate (TURP) Post void residual (PVD) > 200 ml Previous urological history including urethral stricture disease and/or bladder neck disease, urinary retention, bladder stone, chronic prostatitis, bladder cancer, interstitial cystitis, active upper tract stone disease causing symptoms, insulin-dependent diabetes mellitus and non-controlled non-insulin-dependent diabetes mellitus, chronic renal failure
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Stricture Urethra Male subjects ≥ 18 years' old 2. Visual confirmation of stricture via cystoscopy or urethrogram 3. Single lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm 4. One to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) including DVIU (Direct Vision Internal Urethrotomy), but no prior urethroplasty 5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's. 6. IPSS score of 13 or higher 7. Lumen diameter <12F by urethrogram 8. Able to complete validated questionnaire independently 9. Qmax <10 ml/sec Strictures greater than 2.0 cm long. 2. Subjects that have more than 1 stricture. 3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel 4. Subjects who have a suprapubic catheter and are unable to complete study required testing, such as uroflowmetry 5. Previous urethroplasty within the anterior urethra 6. Stricture due to bacterial urethritis or untreated gonorrhea 7. Stricture dilated or incised within the last 3 months 8. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula. 9. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture such as BPH at the discretion of the clinical investigator 10. Previous radical prostatectomy 11. Previous pelvic radiation 12. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months. 13. Diagnosed with chronic renal failure unless under hemodialysis or has a serum creatinine level greater than 2 mg/dL 14. Use of alpha blockers, beta blockers, OAB (Overactive Bladder) medication, anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures), and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months.) 15. Use of Botox (onabotulinumtoxinA) in urinary system within the last 12 months
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Pelvic Floor Disorders Undergoing Urogynecologic surgery Able to consent Greater than 18 years old Non pregnant Need for prolonged catheterization Unable to consent Prisoner
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-79.0, Prostate Cancer Cancer of the PROSTATE Prostatic Neoplasm All men ≥ 40 years age and <80 years of age with a history of prostate cancer and an indication for a prostate biopsy will be offered in the study. Typical indications for biopsy abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam) and/or history of prostate cancer. 2. PSA<50 3. Clinical stage < cT2c Patients will be excluded from being included in the investigation if any of the following is true: 1. Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia 2. Men with known prostate volume (from prior imaging) of > 60cc 3. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy 4. Men who are unable to provide their own informed consent 5. Men who have contraindications to MRI or gadolinium chelate contrast
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-80.0, Arthroplasty, Replacement, Knee Nerve Block Anesthesia, Regional Ambulatory Surgical Procedures patient characteristics suitable for subvastus approach as determined by single surgeon 2. patients willing to undergo ambulatory surgery 3. ability to read and verbally communicate via either English or French age > 80 2. driving distance greater than 1 hour from hospital 3. no willing caregiver at home on night of surgery 4. renal failure requiring dialysis 5. Insulin-dependent diabetes mellitus 6. BMI > 45 7. allergy to study medications 8. pre-existing neurologic deficit involving the ipsilateral limb 9. chronic high dose opioid use (defined as >200mg/day of morphine equivalent for over 2 weeks). 10. inability to use or manage cACB catheter and pump independently at home 11. inability or refusal to cryocompressive therapy device
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urethral Stricture Male >18 years of age bulbar urethral stricture bladder neck contracture <18 years old developmental delay incarcerated individuals history of prior urethroplasty history of cerebrovascular diseases (prior stroke, MI) history of deep vein thrombosis history of pulmonary embolism history of clotting disorders factor 5 Leiden antiphospholipid antibody syndrome
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Rectum Cancer Competent to consent to participate in trial 2. Patients with rectal cancer who underwent total or tumor-specific-mesorectal excision with colorectal or colonanal anastomosis 3. Elective surgery 4. ASA classification of 1~3 5. If male, international prostate symptom score <20 Combined pelvic surgery(pelvic lymph node dissection, hysterectomy, salpingo-oophorectomy, posterior vaginectomy, cystectomy, ureteral double-J stenting, ureterectomy, ureteroureterostomy, prostatectomy) 2. Postoperative complications with a Dindo grade III or more 3. Known urinary disease(end-stage renal disease, benign prostatic hyperplasia, neurogenic bladder, malignancy)
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urethral Diseases Any patient over 18 years with a standard indication for difficult urinary catheterization Any patient younger than 18 years of age, pregnant patients
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2
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 19.0-999.0, Renal Disease > OR = 19 years of age receiving a living donor renal transplant and their donors < 19 years of age No safe extremity to place tourniquet Patients with previous muscle, vascular, or nerve injury to an extremity Patients with only one available extremity that has an arteriovenous fistula Patients who are hemodialysis dependent who have not received hemodialysis in the past 4 days Paraplegic/quadriplegic patients Active pathologic cutaneous lesions on extremities Patients with a history of tourniquet pain or CRPS Pregnant patients
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-80.0, Prostatic Hyperplasia Sign the informed consent. 2. The BPH in-patients who take 'dysuria' as the main self-reported symptom and meet the following conditions, 1) Maximal urinary flow rate less than 20 ml per second, 2) Volume of prostate more than 20ml measured by transrectal ultrasound 3) PSA ranges from 0 to 10ng/ml 4) IPSS>1 The lower urinary tract obstruction caused not by BPH 2. Had a history of prostate cancer, surgery for benign prostatic hyperplasia or neurogenic bladder. 3. using medications known to affect urination or had a severe concomitant disease
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Hyperplasia Prostatic Lower Urinary Tract Symptoms Prostatic Diseases Urological Manifestations Indwelling catheter secondary to benign prostatic hyperplasia (BPH) or Moderate-severe Obstructive LUTS secondary to BPH refractory to medical treatment Unsuitable for TURP or refuse surgery Bladder dysfunction(and known neurological conditions affecting bladder function) Urethral strictures Bladder neck contracture Known sphincter anomalies Big bladder diverticulum or stones Kidney insufficiency (eGFR < 45) Coagulation disturbances Severe atheromatous or tortuosity of arteries Allergy to contrast medium Unable to undergo MR imaging
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-80.0, Benign Prostatic Hyperplasia Age 50-80 Moderate to severe lower urinary tract symptoms secondary to benign prostatic enlargement (BPE) IPSS>14, QOL≥4 Prostate volume ≥ 40 cc Maximum urinary flow rate < 12ml/s Medically refractory BPE > 6 months (or unable/ unwilling to tolerate medical treatment due to side effects) Atherosclerosis of the prostatic arteries Surgical indications (Chronic retention, bladder diverticulae, urethral stenosis), detrusor instability, neurogenic bladder Malignancy (TRUS/ MRI/ Biopsy proven). PSA > 4 or high SWOP risk need prostate biopsy Urodynamics non-obstructed eGFR ≤ 45ml min-1m-2
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Ultrasound Training medical resident rotating through the Pediatric Intensive Care Unit none
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Bladder Cancer Flexible Cystoscopy Non-muscle Invasive Bladder Cancer (NMIBC) Pain, Postoperative Men and women 18 years or older Denovo or recurrent NMIBC Bladder mass discovered in hematuria investigation Willing to share in study inability to cooperate with flexible cystoscopic evaluations cystoscopies for other kind of intervention (e.g., removal of a ureteral stent) Untreated infections Other causes of storage or voiding symptoms as untreated benign prostatic hyperplasia (BPH) or interstitial cystitis Unpassable urethral stricture
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Urinary Stones Ureteral Calculus the patients with large stones (>1.8 cm in size) of the upper ureter male patients the patients planing to be treated with other treatment except laparoscopic ureterolithotomy about the upper ureter stone female patients non operable patients
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, Acute Urinary Retention Benign Prostatic Hyperplasia UroLift System Procedure Arm 1. Male gender 2. Diagnosis of symptomatic BPH 3. Age ≥ 50 years 4. Prostate volume ≤ 100 cc per ultrasound (US) 5. Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker An obstructive or protruding median lobe of the prostate 2. Previous BPH surgical procedure 3. Previous pelvic surgery 4. Urethral conditions that prevents insertion and delivery of device system into bladder 5. Retention volume of >1500 mL 6. Has not had prostate cancer excluded 7. History of prostate or bladder cancer 8. Biopsy of the prostate within the 6 weeks prior to Index Procedure 9. History of neurogenic or atonic bladder 10. Acute or chronic renal failure 11. Known coagulopathies or subject on anticoagulants within 3 days of index procedure (excluding up to 100mg ASA) 12. Known bladder stones within the prior 3 months or treatment within 12 months 13. Prostatitis requiring treatment (antibiotics) within the last year 14. Other co-morbidities that could impact the study results severe cardiac arrhythmias uncontrolled by medications or pacemaker congestive heart failure New York Heart Association (NYHA) III or IV history of uncontrolled diabetes mellitus significant respiratory disease in which hospitalisation may be required known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy) 15. Life expectancy estimated to be less than 5 years 16. Desire to maintain fertility post procedure 17. Unable or unwilling to complete all required questionnaires and follow up assessments 18. Unable or unwilling to sign informed consent form 19. Currently enroled in any other clinical research trial that has not completed the primary endpoint
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Pelvic Fracture Urethra Tear Urethra Injury Male Trauma Surgery Men > 18 years old Blunt force trauma Presence of pelvic fracture Urethral injury Inability to pass a Foley catheter retrograde through the injury into the bladder Straddle type urethral injuries without a pelvic fracture Passage of a catheter successfully in a retrograde fashion
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 60.0-120.0, Osteo Arthritis Knee Criteria:• Patients undergoing primary TKR at the RD+E Hospital Patients must have completed a consent form for the study Patients must be prepared to comply with the pre and post-operative investigations, rehabilitation, attendance schedule and questionnaire schedule of the study Patient in whom any varus deformity present is <20° The diagnosis is of tricompartmental osteoarthritis of the knee Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD) BMI<40 Aged =/> 60 years at time of surgery • Refusal to consent to the study If the knee for surgery has a fixed flexion deformity ≥15° this will be assessed by a lateral "heel-hang" x-ray of the knee for surgery If the knee for surgery has a varus deformity ≥20° If the knee for surgery has a valgus deformity i.e. hip/knee/ankle alignment angle <0° Pre-op Oxford Knee Score <8 Pre-op knee flexion ability <90° If the natural posterior tibial slope measured is in excess of 10° Any patient whose post-operative recovery or ability to comply with the post-operative rehabilitation and assessment schedules is compromised by known existing other medical conditions Pregnancy
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Multiple Sclerosis Lower Urinary Tract Symptoms Gait Multiple sclerosis Follow in neuro-urology for lower urinary tract symtpoms Able to walk 50 meters without human assistance able to hold on void during 3 minutes at least actual urinary tract infection relapse in the last week Mini Mental State Examination < 10
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Crohn Disease Inflammatory Bowel Diseases Stricture; Bowel Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy Acute bowel obstruction requiring urgent surgical intervention Deemed by treating physician to have high risk of acute bowel obstruction Concurrent active perianal sepsis Internal fistulising disease in association with strictures (entero-enteric stulas) Low rectal or anal strictures Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies Patients for whom endoscopy is not suitable due to co-morbidities or clinical state Inability to give informed consent Suspected perforation of the gastrointestinal tract Pregnancy
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-85.0, Pregabalin on Catheter Related Bladder Discomfort All patients about to be subjected to urinary operations Signed informed consent Preoperative urinary bladder/kidney dysfunction as a result of spinal cord pathology History of overactive ((urinary frequency>3 times at night and >8 times in 24 hours), neurogenic bladder End stage renal failure Central nervous system dysfunction Mental illness/ substance abuse Sensitivity to pregabalin Preoperative administration of pregabalin for other indications Recent bladder catheterization <3 months
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Locally Advanced Renal Pelvis Urothelial Carcinoma Locally Advanced Ureter Urothelial Carcinoma Locally Advanced Urethral Urothelial Carcinoma Metastatic Renal Pelvis Urothelial Carcinoma Metastatic Ureter Urothelial Carcinoma Metastatic Urethral Urothelial Carcinoma Recurrent Bladder Urothelial Carcinoma Recurrent Renal Pelvis Urothelial Carcinoma Recurrent Ureter Urothelial Carcinoma Recurrent Urethral Urothelial Carcinoma Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 Stage III Renal Pelvis Cancer AJCC v7 Stage III Ureter Cancer AJCC v7 Stage III Urethral Cancer AJCC v7 Stage IV Bladder Urothelial Carcinoma AJCC v7 Stage IV Renal Pelvis Cancer AJCC v7 Stage IV Ureter Cancer AJCC v7 Stage IV Urethral Cancer AJCC v7 Unresectable Renal Pelvis Urothelial Carcinoma Unresectable Ureter Urothelial Carcinoma Unresectable Urethral Urothelial Carcinoma Histologically or cytologically-confirmed diagnosis of locally advanced/unresectable (inoperable or not amenable to surgical treatment) and/or metastatic transitional cell urothelial cancer of the renal pelvis, ureter, urinary bladder, or urethra Presence of measurable disease meeting the following At least one lesion of >= 1.0 cm in long axis diameter for non-lymph nodes or >= 1.5 cm in short axis diameter for lymph nodes that is serially measurable according to 1.1 using either computerized tomography or magnetic resonance imaging or panoramic and close-up color photography with caliper measurement; if there is only one target lesion and it is a not a lymph node, it should have a long-axis diameter of at least 1.5 cm Lesions that have had radiotherapy must show radiographic evidence of disease progression based on 1.1 may be deemed a target lesion Archival paraffin-embedded invasive tumor tissue or newly obtained biopsy must be available prior to the first dose of study drug for biomarker analysis; patients must be offered sequential biopsies at baseline and 6 weeks unless in the opinion of the trial principal investigator (PI) this would be hazardous; recent data suggest discordance between primary tumor and tumor from recurrence or metastasis with high percentages of PD-L1 SP142 positive immune cells after recurrence PD-L1 status determined centrally by HistogeneX, which is funded by the study, must be available before randomization of the patient to allow for stratification; OF PD-L1 AT THE SITE WILL NOT New, progressive or recurrent disease occurring During or within 12 months of treatment with a platinum containing regimen (cisplatin or carboplatin or novel platinum) in either in the metastatic or perioperative setting In first-line patients defined as cisplatin-ineligible based on renal impairment (creatinine clearance calculated by Cockcroft-Gault method < 60 ml/min), grade 2 hearing loss and/or Eastern Cooperative Oncology Group (ECOG) status of 2; these patients will be chemotherapy naive or have received platinum based therapy in the adjuvant or neoadjuvant setting more than 12 months prior to study entry Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation Patients who have had chemotherapy within 3 weeks or radiotherapy or targeted therapy 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier; however, the following therapies are allowed Hormone-replacement therapy or oral contraceptives Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1) Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1 Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents or eribulin Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose No history of severe immune-related adverse effects from anti-CTLA-4 (National Cancer Institute [NCI] Common Terminology for Adverse Events [CTCAE] version 5.0) Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 21.0-65.0, Urologic Diseases Male Urogenital Diseases Urethral Stricture Urethral Injury Stricture of the anterior urethra meeting the following 1. History of at least one previously failed attempt at conservative management, at least 6 months prior to study. 2. Urethral stricture of 10-60 mm in length, as determined by urethrography. 3. Contains at least 1 strictured segment through which a 16 Fr flexible cystoscope cannot be atraumatically passed. 2. Patients must be available for all follow-up visits. 3. Ability to speak English Any of the following is regarded as a criterion for excluding a subject from the study: 1. Strictures of the meatus or prostatic urethra; any urethral stricture associated with or suspected to be urethral carcinoma, or strictures due to pelvic distraction injuries. Strictures <10 mm or >60 mm, as determined by urethrography, and for bulbar urethral strictures excluding those with strictures <20 mm and >60 mm, as described by urethrography. 2. Presence of untreated urinary tract infection. 3. Presence or prior history of lichen sclerosus et atrophicus (previously termed 'balanitis xerotica obliterans'). 4. Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia or patients routinely receiving blood products for bleeding disorders. 5. Any urological condition that would be likely to require additional urethral instrumentation during the period of investigation, including, but not limited to benign prostatic hyperplasia requiring treatment, use of alpha blockers, active prostate cancer, an unevaluated elevated prostate surface antigen (PSA), bladder cancer, or any recurrent urinary stone formation. Patients with evidence or diagnosis of any coagulation disorder (including concomitant anti-coagulation therapy at enrollment). 6. Serum creatinine > 2.0 mg/dl or evidence of progressive renal disease. 7. Patients with abnormal urologic conditions, including vesicoureteral reflux, bladder stones, bladder tumors and renal impairment. 8. Subjects with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >3 times the upper limit of normal. 9. Subjects with an albumin value <3.0 g/dL. 10. Subjects with uncontrolled diabetes, unstable cardiac and/or pulmonary disorders. 11. Subjects with active tuberculosis (TB) requiring treatment in the past 3 years. Subjects with a current positive (≥5 mm induration for high-risk subjects; otherwise ≥10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment. 12. Subjects known to be colonized with either methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms. 13. Immunocompromised subjects or subjects receiving immunosuppressive agents (inhaled corticosteroids and chronic low-dose corticosteroids [≤0.25 mg/kg prednisone or equivalent per day] are permitted). 14. Any history of alcohol and/or drug abuse. 15. Current smoker. 16. Documented history of, or positive result of HIV, Hepatitis B or C, or any infectious disease. External signs, sequelae, or positive serology of sexually transmitted disease (including HPV). Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study. 17. Concurrent participation in any other clinical investigation during the period of this investigation. Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study. 18. Any current illness that might confound the results of this investigation, including but not limited to bladder atonia, neuropathic/neurogenic bladder, bladder outlet obstruction (other than urethral stricture), sphincteric dysfunction, or spinal cord injury. 19. Any circumstance in which the investigator deems participation in the study is not in the subject's best interest. 20. Inability to participate in all necessary study activities due to physical or mental limitations. 21. Inability or unwillingness to return for all required follow-up visits. 22. Inability or unwillingness to sign informed consent. 23. Patients requiring concomitant use of or treatment with immunosuppressive agents. 24. Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease)
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 12.0-17.0, Type2 Diabetes Type 2 Diabetes Mellitus Insulin Sensitivity Insulin Resistance Depression Adolescent Obesity Female Age 12-17 years Body mass index (BMI) ≥85th percentile for age & sex Center for Epidemiologic Studies-Depression Scale (CES-D) >20 English speaking ≥1 first or second-degree family member with type 2 diabetes (T2D), prediabetes, or gestational diabetes Good general health Pregnancy or breastfeeding Type 2 diabetes as indicated by fasting glucose≥126 mg/dL or 2-hour glucose>200 mg/dL or Hba1c>=6.5 Medication affecting mood, weight, cortisol, or insulin sensitivity, including insulin sensitizers (e.g., metformin), anti-depressants, and stimulants Major psychiatric disorder that, in the opinion of the investigators, would impede study compliance and necessitate more intensive treatment, including major depressive disorder, bipolar disorder, posttraumatic stress disorder, panic disorder, obsessive-compulsive disorder, schizophrenia, conduct disorder, alcohol and substance abuse, and anorexia/bulimia nervosa Psychotherapy or structured weight loss program Active suicidal ideation or suicidal behavior
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2
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Asymptomatic Bacteriuria Antibiotic Prophylaxis Age ≥ 18 years Patients with asymptomatic bacteriuria identified with a urine culture prior to the surgical procedure and with a microorganism that meets the following 1) gram-negative bacteria in the enterobacterial family and non-fermenting bacilli; 2) Bacteria with resistance profile has a therapeutic option that reaches therapeutic concentration in urine Patients scheduled for urological procedures, such as: transurethral resection of the prostate, open prostatectomy, cystoscopy, extracorporeal lithotripsy and flexible ureterorenoscopy Informed consent Patients with chronic renal failure; with immunosuppressive status secondary to glucocorticoid consumption, haematological or solid organ neoplasms undergoing chemotherapy or radiation therapy or neutropenia Patients with active infection or clinical of urinary infection Patients who voluntarily do not want to participate in the study Patients who can not give informed consent under reasonable or vulnerable conditions Patients who present type I allergy to penicillin Patients who have scheduled surgeries combined with a discipline different to urology
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urethral Stricture Male subjects ≥ 18 years' old 2. Visual confirmation of stricture via cystoscopy or urethrogram 3. Single lesion anterior urethral stricture less than or equal to 3 cm 4. Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual internal urethrotomy), but no prior urethroplasty 5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's (urinary tract infections). 6. IPSS (International Prostate Symptom Score) score of 13 or higher 7. Lumen diameter <12F by urethrogram 8. Able to complete validated questionnaire independently 9. Qmax <12 ml/sec 10. Guidewire must be able to cross the lesion Strictures greater than 3.0 cm long. 2. Subjects that have more than 1 stricture. 3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel 4. Subjects who have a suprapubic catheter 5. Previous urethroplasty within the anterior urethra 6. Stricture due to bacterial urethritis or untreated gonorrhea 7. Stricture dilated or incised within the last 3 months 8. History of over active bladder or stress incontinence 9. Previous radical prostatectomy 10. Previous pelvic radiation 11. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months. 12. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate 13. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Carcinoma, Transitional Cell Urinary Bladder Neoplasms Urologic Neoplasms Renal Pelvis Neoplasms Urothelial Cancer Ureteral Neoplasms Urethral Neoplasms Locally advanced or metastatic urothelial cancer (la/mUC) Cohorts A, B, D, E, F, G and K Histologically documented la/mUC, including squamous differentiation or mixed cell types An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2: Participants with ECOG performance status of 2 must meet the following additional hemoglobin ≥10 g/dL, GFR ≥50 mL/min, may not have NYHA Class III heart failure Eligible for pembrolizumab (Dose-escalation cohorts, Cohorts A, B, G and K Combination Arm) Dose-escalation cohorts: Ineligible for first-line cisplatin-based chemotherapy and no prior treatment for la/mUC, or have disease progression following at least 1 platinum-containing treatment Cohort A: Ineligible for cisplatin-based chemotherapy and no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months Cohort B: Must have disease progression during/following treatment with at least 1 platinum-containing regimen for la/mUC or disease recurrence Cohort D: Eligible for cisplatin-based chemotherapy and no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months Cohort E: Ineligible for cisplatin-based chemotherapy, eligible for carboplatin, and no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months la/mUC Cohorts A, B, D, E, F, G, and K Received any prior treatment with a PD-1 inhibitor, PD-L1 inhibitor, or PD-L2 inhibitor, except Cohort F Received any prior treatment with stimulatory or co-inhibitory T-cell receptor agents, such as CD137 agonists, OX-40 agonists, or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors (except Cohort F) Ongoing sensory or motor neuropathy Grade 2 or higher Active central nervous system (CNS) metastases Ongoing clinically significant toxicity (Grade 2 or greater) associated with prior treatment (including radiotherapy or surgery) Conditions requiring high doses of steroids or other immunosuppressive medications Prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs) Uncontrolled diabetes mellitus
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Renal Cell Carcinoma Urothelial Carcinoma Bladder Cancer Ureter Cancer Urethral Cancer Eligible patients will retrospectively identified patients with RCC or UC who have received treatment with ICB and achieved clinical benefit but subsequently developed a solitary new/progressive lesion that was removed surgically. Patients with other tumor types who otherwise meet may be included at a later time Additionally, a group of patients with RCC who have undergone a metastasectomy but who did not receive treatment with ICB will be identified. These patients may be approached for study participation to serve as a comparator group
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 41.0-80.0, Urinary Retention Inguinal Hernia Males of 41 to 80 years old who are going for elective inguinal hernia repair (laparoscopic or open) under general anesthesia Patient whom has any of the following will be excluded Contraindication to tamsulosin : known allergy, known orthostatic hypotension, significant cardiac co-morbidities ( New york heart association functional classification >2) or heart failure End stage renal failure More than two anti-hypertensive use/long term alpha blockers/beta blockers/anticholinergic (eg : buscopan) Previous urological or pelvic surgery Known benign prostatic hyperplasia on medications Long term indwelling catheters Concurrent neurologic disease such as stroke, poliomyelitis, cerebral palsy, multiple sclerosis, spinal lesions, diabetic and alcoholic neuropathy
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Failed Anastomotic Urethroplasty patient with normal bladder. 2-Patient with fructure pelvis Patient without fracture pelvis. 2-Patient with other pathology as neurogenic bladder
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Acute Kidney Injury Elective or semi-elective/urgent Cardiac surgery patients in whom CPB is a planned part of the procedure years or older Urinary catheter is planned during the surgery Contra-indications to urinary catheter Pre-operative dialysis dependent end stage renal disease Emergency cases
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, Urinary Retention Males > 50 years of age Signed subject informed consent (see Appendix "A") Patients with actual urinary retention dependent on Foley Catheter or Intermittent Catheter will start once the M3 is placed and a functioning bladder is demonstrated Inability to undergo bladder catheterization with the M3 due to anatomical challenges (i.e. urethral stricture, bladder neck contracture, false passage or false passages or other history of urethral stricture) Gross hematuria Hypotonic Neurogenic Bladder (the placement of the M3 may isolate the cause of the retention with the bridging of the prostate as bladder dysfunction rather than prostate obstruction)
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Catheter-Related Discomfort Patients scheduled to undergo radical prostatectomy at the Massachusetts General Hospital Anticipated intra-operative placement of an 18 or 20 French, latex or silicone urethral catheter at the conclusion of the operation (standard of care) At least 18 years of age Inability to speak, read or understand English Apparent sore, rash, or infection on the penis Anatomic abnormalities that would prevent proper application and use of the device Patients with significant physical or mental disability that, in the opinion of the treating surgeon, might prevent safe placement or removal of the device, or completion of the symptom-based survey Patients with fragile skin
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Localised Prostate Cancer Locally Advanced Prostate Cancer Locally Recurrent Prostate Cancer Benign Prostatic Hyperplasia Shared for all groups Language spoken: Finnish, English or Swedish Mental status: Patients must be able to understand the meaning of the study Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff Potential prostate biopsies obtained > 6 weeks before HIFU/TULSA-PRO treatment (or at the discretion of PI) Eligible for MRI Eligible for spinal or general anesthesia (ASA 3 or less) Succession of urethral catheterization/Patency of prostatic urethra confirmed if needed with pre-HIFU cystoscopy Group-specific Group 1. Localized PC prior to RP All localized PC patients planned for robot assisted laparoscopic prostatectomy (RALP) with normal standards of care are eligible for this study (EAU guidelines) MRI-visible biopsy proven PC (biopsies obtained < 6 months before treatment) Group 2. Locally symptomatic locally advanced and/or metastatic prostate cancer in need of palliative surgical intervention for all groups Prostate calcifications >1cm in largest diameter located in the anticipated treatment sector on baseline TRUS or MRI Prostate cysts >1cm in largest diameter located in the anticipated treatment sector on baseline TRUS or MRI History of chronic inflammatory conditions (e.g. inflammatory bowel disease) affecting rectum (also includes rectal fistula and anal/rectal stenosis) Contraindications for MRI (cardiac pacemaker, intracranial clips etc.) Uncontrolled serious infection Claustrophobia Hip replacement surgery or other metal in the pelvic area Severe kidney failure (glomerular filtration rate (GFR) <30ml/min/1.73m2) usage of gadolinium in contrast-enhanced imaging unless justifiable based on the clinical judgment of the responsible radiologist and/or urologist Known allergy to gadolinium
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Catheters, Indwelling Catheter-Related Infections years or older hospitalized in Ryhov County Hosptial, Sweden, with perhiperal venous catheter in situ for 48 hours or more Under 18 years of age
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-999.0, Lower Urinary Tract Symptoms Male, 45 years or older. 2. The presence of lower urinary tract symptoms, i.e. frequency, urgency, urge incontinence, dysuria, post-micturition dribble, etc. 3. All participants have signed the informed consent form. 4. Clinical data comes from 23 selected hospitals spread across China Lower urinary tract symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc. 2. Diagnosis or suspicion of renal, ureteral, bladder, prostate, urethral or pelvic tumor. 3. Known neurogenic or congenital lower urinary tract dysfunction. 4. Known urinary tract, prostate or pelvic surgical history. 5. Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.). 6. The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc. 7. Patients with poor compliance or cognitive competence
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1
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