Clinical trials: Urinary Incontinence, Stress
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
Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in…
- Trial name
- CELLEBRATE (NCT03104517)
- Testing
- AMDC-USR (iltamiocel)
- Where
- 21 sites in United States, United Kingdom
- Volunteers
- 96 people
- Sponsor
- Cook MyoSite
Urinary Incontinence,Stress
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
The GZPS master protocol will support two independent studies, J2A-MC-GZS1 and J2A-MC-GZS2. Each study will see how well and safely orforglipron works in adult female participants with stress urinary incontinence (SUI) who have…
- Trial name
- RESTRAIN-SUI (NCT07202884)
- Testing
- Orforglipron
- Where
- 136 sites in United States, Canada and 8 more
- Volunteers
- 1,000 people
- Sponsor
- Eli Lilly and Company
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
Urinary Incontinence, Urinary Incontinence,Stress
Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a…
- Trial name
- NCT04248283
- Testing
- Adjustable Continence Therapy for Women (ACT)
- Where
- 8 sites in United States, France
- Volunteers
- 167 people
- Sponsor
- Uromedica
Stress Urinary Incontinence in Women
Treated Umbilical Vein Allograft (UVT) Versus Autologous Fascial Pubovaginal Sling in the Treatment of Female Stress Urinary Incontinence
The goal of this clinical trial is to evaluate whether a treated umbilical vein allograft is effective in treating stress urinary incontinence in females.
- Trial name
- NCT06678984
- Testing
- with treated umbilical vein allograft, with autologous fascial pubovaginal sling
- Where
- 8 sites in France
- Volunteers
- 96 people
- Sponsor
- TBF Genie Tissulaire
Radical Prostatectomy, Stress Urinary Incontinence (SUI)
Pivotal Study of Voro Urologic Scaffold
The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm.
- Trial name
- ARID II (NCT06873581)
- Testing
- Voro Urologic Scaffold
- Where
- 19 sites in United States
- Volunteers
- 266 people
- Sponsor
- Levee Medical, Inc.
Urinary Incontinence, Urinary Incontinence (UI)
Trial of NASHA Dx Urethral Bulking System
Prospective, randomized, single-blind study to evaluate the safety and efficacy of NASHA Dx investigational device compared to controlled device Bulkamid in adult women with mild, moderate and intrinsic sphincter deficiency (ISD).
- Conditions
- Urinary Incontinence, Urinary Incontinence (UI), Urinary Incontinence , Stress, Urinary Incontinence Due to Urethral Sphincter Incompetence
- Trial name
- NASHA-DX (NCT07850804)
- Testing
- NASHA Dx, Bulkamid
- Where
- 5 sites in United States
- Volunteers
- 314 people
- Sponsor
- Palette Life Sciences, Inc.
Stress Urinary Incontinence
Desara ® One Single Incision Sling 522 Study
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
- Trial name
- NCT04772131
- Testing
- Desara® One Single Incision Sling, Desara® Blue Transobturator Sling
- Where
- 15 sites in United States
- Volunteers
- 300 people
- Sponsor
- Caldera Medical, Inc.
Stress Urinary Incontinence
Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
The main purpose of this registry is to collect observational, long-term safety and effectiveness data in subjects who have received at least one dose of iltamiocel as part of the CLBT clinical study.
- Trial name
- CLBT RGST (NCT06743620)
- Testing
- iltamiocel
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- Cook MyoSite
Stress Urinary Incontinence (SUI)
A Study of Two Versions of the Uresta Pessary Handle for Women With Stress Urinary Incontinence
The goal of this clinical trial is to learn if a new handle design for the uresta pessary works better than the current handle design for women when they are using the pessary.
- Trial name
- NCT07706491
- Testing
- pessary handle
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Resilia Inc.
Stress Urinary Incontinence, Pelvic Organ Prolapse
Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including…
- Trial name
- NCT04829175
- Testing
- Intervention
- Where
- 10 sites in United States, Austria and 5 more
- Volunteers
- 1,000 people
- Sponsor
- Ethicon, Inc.
Stress Urinary Incontinence
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
- Trial name
- NCT04829357
- Testing
- Intervention
- Where
- 4 sites in United States, Italy and 1 more
- Volunteers
- 195 people
- Sponsor
- Ethicon, Inc.
Stress Urinary Incontinence
Post-Market Clinical Follow-Up onTVT EXACT® Continence System
The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
- Trial name
- NCT04829994
- Testing
- Intervention
- Where
- 8 sites in United States, Austria and 4 more
- Volunteers
- 198 people
- Sponsor
- Ethicon, 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
Urinary Incontinence, Stress
A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence
The purpose of this study is to monitor the use of Altis Single Incision Sling (SIS) in a real world population and collect medical data on effectiveness and to monitor safety of Altis SIS at 12 and 36 months post device…
- Trial name
- NCT04115605
- Testing
- Altis Single Incision Sling
- Where
- 33 sites in Belgium, France and 3 more
- Volunteers
- 598 people
- Sponsor
- Coloplast A/S
Mixed Urinary Incontinence, Stress Urinary Incontinence (SUI)
Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)
Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.
- Conditions
- Mixed Urinary Incontinence, Stress Urinary Incontinence (SUI), Chronic Pelvic Pain, Urge Urinary Incontinence
- Trial name
- AURA-4X (NCT06885931)
- Testing
- Pudendal neuromodulation
- Where
- 7 sites in Belgium, Netherlands and 1 more
- Volunteers
- 86 people
- Sponsor
- Amber Therapeutics Ltd
Urinary Incontinence,Stress, Urinary Incontinence, Urge
RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application
This study, titled "Prospective Randomized Study on Multimodal Self-Treatment for Women with Incontinence Symptoms Using a Digital Health Application," abbreviated as DINKS, aims to investigate the efficacy of a digital health…
- Conditions
- Urinary Incontinence,Stress, Urinary Incontinence, Urge, Urinary Incontinence, Overactive Bladder Syndrome
- Trial name
- DINKS (NCT06389838)
- Testing
- Kranus Mictera
- Where
- Germany
- Volunteers
- 194 people
- Sponsor
- Kranus Health GmbH
Stress Urinary Incontinence (SUI)
Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence
The goal of this pivotal clinical trial is to evaluate the safety and effectiveness of the SUI-100 device for the treatment of mild-to-moderate stress urinary incontinence (SUI) in females aged 22-70 years.
- Trial name
- SaHARA (NCT06862648)
- Testing
- Acoustic Stimulation Therapy Device
- Where
- 9 sites in United States
- Volunteers
- 130 people
- Sponsor
- Acoustic Wave Cell Therapy, Inc.
Urinary Incontinence,Stress
Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Men
Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter.
- Trial name
- SOPHIA (NCT05547672)
- Testing
- UroMems artificial urinary sphincter
- Where
- 2 sites in France
- Volunteers
- 6 people
- Sponsor
- UroMems SAS