Clinical trials: Disorder of the Lower Urinary Tract
Stress Urinary Incontinence
ProACT Post-Approval Study
The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation.
- Trial name
- NCT03767595
- Testing
- ProACT Adjustable Continence Therapy for Men
- Where
- 14 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Uromedica
Stress Urinary Incontinence, Radical Prostatectomy
Feasibility Study of A VoRo UrologIc ScaffolD (ARID)
The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.
- Trial name
- ARID (NCT06275945)
- Testing
- Voro Urologic Scaffold
- Where
- Panama
- Volunteers
- 40 people
- Sponsor
- Levee Medical, Inc.
Urinary Incontinence
An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
This clinical trial is being conducted to investigate the safety and effectiveness of a new device designed to treat urinary urge incontinence in those patients who have tried and failed two or more conservative therapies.
- Trial name
- NCT00080470
- Testing
- bion
- Where
- 11 sites in United States
- Volunteers
- 148 people
- Sponsor
- Boston Scientific Corporation
Stress Urinary Incontinence (SUI)
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Prospective, multicenter, single-arm study
- Trial name
- SOPHIA2 (NCT06968741)
- Testing
- Artificial Urinary Sphincter (AUS)
- Where
- 21 sites in United States, France
- Volunteers
- 140 people
- Sponsor
- UroMems SAS
Stress Urinary Incontinence
A Study to Evaluate the Effectiveness of the Induced Reflex Cough Test Plus Urodynamics to Identify Stress Urinary Incontinence in Female Subjects With a History of Stress Urinary Incontinence
This study is to evaluate the effectiveness of identifying stress urinary incontinence (SUI) in female subjects using the Induced Reflex Cough Test (IRCT) administered with urodynamic testing by evaluation of sensitivity and…
- Trial name
- NCT00801203
- Testing
- IRCT
- Where
- 10 sites in United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Pneumoflex Systems, LLC
Urinary Bladder, Overactive
Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity
This study will evaluate the efficacy and safety of GSK1358820 in Japanese patients with neurogenic detrusor overactivity (NDO) with urinary incontinence, whose symptoms have not been adequately managed with medications for…
- Trial name
- NCT02849418
- Testing
- GSK1358820
- Where
- 9 sites in Japan
- Volunteers
- 21 people
- Sponsor
- GlaxoSmithKline
Benign Prostatic Hyperplasia
The Safety and Effectiveness of UroLift: LIFT Pivotal Study
The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System when used in subjects with symptomatic benign hyperplasia (BPH).
- Trial name
- LIFT (NCT01294150)
- Testing
- UroLift System, Cystoscopy, Crossover
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 206 people
- Sponsor
- NeoTract, Inc.
Urge Incontinence
Protect Chronic Tibial Nerve Stimulator (CTNS) System
30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days.
- Trial name
- NCT02781636
- Testing
- Device: StimGuard Protect System
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Uro Medical Corporation
Neurogenic Detrusor Overactivity, Overactive Bladder
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
The purpose of this study is to evaluate the pharmacokinetics as well as the safety and tolerability of mirabegron OCAS tablets after single-dose administration at different dose levels in children and adolescents with NDO or OAB.
- Conditions
- Neurogenic Detrusor Overactivity, Overactive Bladder, Pharmacokinetics of Mirabegron
- Trial name
- NCT02211846
- Testing
- Mirabegron
- Where
- 13 sites in Belgium, Denmark and 3 more
- Volunteers
- 34 people
- Sponsor
- Astellas Pharma Inc
Urinary Incontinence , Stress
Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women
The subjects will be implanted with the ARTUS® medical device and then be followed up to 2 years post-implantation, with the primary endpoints measured at 3-month post-implantation.
- Trial name
- SPHIN-X (NCT07641218)
- Testing
- Artificial Urinary Sphincter ARTUS
- Where
- 2 sites in France
- Volunteers
- 6 people
- Sponsor
- Myopowers Medical Technologies France SAS
Urethral Stricture, Urethral Stricture, Anterior
Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study
The ROBUST IV study is designed to collect and better understand "real-world" outcomes for men undergoing urethral dilation using the Optilume Drug Coated Balloon (DCB) for treatment of urethral stricture.
- Conditions
- Urethral Stricture, Urethral Stricture, Anterior, Lower Urinary Tract Symptoms, Anterior Urethral Stricture
- Trial name
- ROBUST IV (NCT03851952)
- Testing
- Optilume Drug Coated Balloon
- Sponsor
- Urotronic Inc.
Overactive Bladder Syndrome
A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
This study will assess the efficacy of a 12-week treatment with darifenacin in increasing warning time, the time from first sensation of urgency to voiding, in patients with OAB.
- Trial name
- NCT00171145
- Testing
- Darifenacin
- Where
- United States
- Volunteers
- 445 people
- Sponsor
- Novartis
Endometriosis Related Pain, Overactive Bladder
Study on the Safety of Drug BAY1817080 at Different Doses and the Way the Body Absorbs and Eliminates the Drug in Japanese Healthy Adult Male Participants
Researchers in this study want to learn about the safety of drug BAY1817080 at different doses and the resulting blood levels of the study drug in Japanese healthy adult male participants.
- Conditions
- Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough
- Trial name
- NCT04265781
- Testing
- BAY1817080
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
Urge Urinary Incontinence, Urinary Frequency
Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel.
- Trial name
- NCT00909181
- Testing
- Oxybutynin
- Where
- 55 sites in United States
- Volunteers
- 626 people
- Sponsor
- Antares Pharma Inc.
Benign Prostatic Hyperplasia
Real World Data on Management of Male LUTS
This study will describe the current medical care given to men who discuss their lower urinary tract symptoms with a HCP. It will document the primary reasons for the visit, the baseline characteristics of these men, the…
- Trial name
- NCT03075449
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Boehringer Ingelheim
Urinary Incontinence
UK PureWick™ At-Home Pilot Study
The UK PureWick™ At-Home Study is being carried out to see how well the PureWick™ Collection System works for women who use it at home instead of a traditional catheter. Traditional catheters are placed inside the body.
- Trial name
- NCT07555548
- Testing
- Treatment with the PureWick™ Urine Collection System External Catheter which is a non-invasive device designed to manage urinary incontinence
- Where
- 4 sites in United Kingdom
- Volunteers
- 95 people
- Sponsor
- Becton, Dickinson and Company
Urinary Incontinence, Overactive Bladder
Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1
The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult…
- Trial name
- CONTENT1 (NCT02660138)
- Testing
- Botulinum toxin type A
- Where
- 81 sites in United States, Canada and 8 more
- Volunteers
- 227 people
- Sponsor
- Ipsen
Benign Prostatic Hyperplasia
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the…
- Trial name
- RAPID-III (NCT06849258)
- Testing
- FloStent
- Where
- 20 sites in United States, Australia
- Volunteers
- 215 people
- Sponsor
- Rivermark Medical
Urinary Incontinence,Stress
Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Women
Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter in women
- Trial name
- NCT05828979
- Testing
- UroMems artificial urinary sphincter
- Where
- 2 sites in France
- Volunteers
- 6 people
- Sponsor
- UroMems SAS
Phase 1, Healthy
EC905 Pharmacokinetic Profile Study
A study to compare the pharmacokinetics of tamsulosin HCl and solifenacin succinate after co-administration of single entity tablets and of the combination tablet EC905 under steady state conditions at three dose strengths.
- Conditions
- Phase 1, Healthy, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- Trial name
- NCT02634489
- Testing
- Tamsulosin HCl, Solifenacin Succinate, EC905
- Where
- Netherlands
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.