Clinical trials: Incontinence
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
Depressive Symptoms, Urinary Incontinence
BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women
The goal of this clinical trial is to evaluate if the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices is able to improve depressive symptoms and sexual function in women who are perimenopausal or…
- Conditions
- Depressive Symptoms, Urinary Incontinence, Sexual Dysfunction
- Trial name
- NCT07413705
- Testing
- EXOMIND (BTL-699-2) Active Treatment, EMSELLA (HPM-6000UF) ActiveTreatment
- Where
- 3 sites in United States, Canada
- Volunteers
- 41 people
- Sponsor
- BTL Industries Ltd.
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
This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting.
This post-market study will assess the performance of and user satisfaction with the PureWick® Male External Catheter in a home setting.
- Trial name
- PUREST-M (NCT06850259)
- Testing
- PureWick® Urine Collection System, UltraFlex™ Self-Adhering Male External Catheter
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- C. R. Bard
Urinary Incontinence, Urge, Urinary Bladder, Overactive
INTIBIA Pivotal Study
Prospective, randomized, double-blind, multicenter study to evaluate the safety and efficacy of an implantable tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
- Conditions
- Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Bladder Diseases, Urologic Diseases
- Trial name
- NCT05250908
- Testing
- INTIBIA Therapeutic, INTIBIA Non-Therapeutic
- Where
- 22 sites in United States, Netherlands
- Volunteers
- 208 people
- Sponsor
- Coloplast A/S
Fecal Incontinence
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal…
- Trial name
- DigniFI (NCT05776277)
- Testing
- Iltamiocel
- Where
- 25 sites in United States
- Volunteers
- 200 people
- Sponsor
- Cook MyoSite
Urge Urinary Incontinence
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
The purpose of this prospective, multicenter study is to assess the long-term safety and effectiveness of the Altaviva™ system for the treatment of UUI
- Trial name
- ENDURANCE™ (NCT07456865)
- Testing
- Altaviva™ system
- Where
- 19 sites in United States
- Volunteers
- 256 people
- Sponsor
- MedtronicNeuro
Overactive Bladder, Urge Incontinence
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
A prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the eCoin® implanted tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
- Conditions
- Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence
- Trial name
- RECIPE (NCT05685433)
- Testing
- eCoin Tibial Nerve Stimulation
- Where
- 22 sites in United States
- Volunteers
- 200 people
- Sponsor
- Valencia Technologies Corporation
Stress Incontinence Female
Effect of Pelvic Floor Muscle Training Combined With Dietary Supplementation on Urinary Incontinence and Pelvic Floor Muscle Function in Women
Pelvic floor muscle training (PFMT) is commonly used in the conservative management of urinary incontinence. The aim of the study is to investigate changes in urinary incontinence symptoms and pelvic floor muscle function during…
- Trial name
- NCT07859241
- Testing
- Incoxil
- Volunteers
- 100 people
- Sponsor
- FEMPHARMA Kft.
Urinary Urge Incontinence
Neuspera Revision Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics
Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.
- Trial name
- NCT07383688
- Testing
- Neuspera Implantable Sacral Neuromodulation System
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Neuspera Medical, Inc.
Overactive Bladder, Fecal Incontinence
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
To collect physiological signals at several timepoints during the therapy evaluation period.
- Conditions
- Overactive Bladder, Fecal Incontinence, Urinary Retention
- Trial name
- PEER 2 (NCT05200923)
- Testing
- Sacral Neuromodulation
- Where
- 7 sites in United States
- Volunteers
- 300 people
- Sponsor
- MedtronicNeuro
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
F15 Recharge Free Axonics SNM System Clinical Study
Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.
- Conditions
- Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI)
- Trial name
- NCT06186765
- Testing
- Axonics SNM System (Model 4101)
- Where
- 16 sites in United States, Netherlands and 1 more
- Volunteers
- 144 people
- Sponsor
- Axonics, Inc.
Overactive Bladder, Urinary Urgency Incontinence
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
- Conditions
- Overactive Bladder, Urinary Urgency Incontinence, Benign Prostatic Hyperplasia, Prostate Cancer
- Trial name
- NCT06511141
- Testing
- Axonics SNM System
- Where
- 23 sites in United States
- Volunteers
- 150 people
- Sponsor
- Axonics, Inc.
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
- Conditions
- Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Overactive Bladder (OAB)
- Trial name
- NCT06789406
- Testing
- Axonics SNM System INS Model 5101 (R20)
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 55 people
- Sponsor
- Axonics, Inc.
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
- Conditions
- Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI), Overactive Bladder (OAB)
- Trial name
- NCT07335484
- Testing
- Axonics External Trial System (ETS)
- Where
- 5 sites in United States, Australia
- Volunteers
- 75 people
- Sponsor
- Axonics, Inc.
Fecal Incontinence
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
- Trial name
- NCT07499258
- Testing
- Axonics SNM System INS Model 5101 (R20)
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 55 people
- Sponsor
- Axonics, Inc.
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