Clinical trials: Incontinence
Fecal Incontinence
Autologous Cell Therapy for Treatment of Fecal Incontinence
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment…
- Trial name
- NCT01600755
- Testing
- Iltamiocel
- Where
- 2 sites in Canada, United Kingdom
- Volunteers
- 53 people
- Sponsor
- Cook MyoSite
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.
Overactive Bladder, Fecal Incontinence
InterStim Micro Post Market Clinical Follow-up Study (ELITE)
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
- Conditions
- Overactive Bladder, Fecal Incontinence, Non-obstructive Urinary Retention
- Trial name
- ELITE (NCT04506866)
- Testing
- InterStim Micro
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 148 people
- Sponsor
- MedtronicNeuro
Urinary Incontinence, Stress
The AttenueX IntraVesical System for the Treatment of Female Stress Urinary Incontinence
Over 11 million women in the United States suffer from stress urinary incontinence (SUI), the involuntary leakage of urine during routine physical activities such as laughing, coughing, exercising, or sneezing.
- Trial name
- NCT00492596
- Testing
- AttenueX IntraVesical System
- Where
- 13 sites in United States
- Volunteers
- 166 people
- Sponsor
- Solace Therapeutics, Inc.
Urinary Incontinence
Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence
Study to evaluate the safety and effectiveness of Yoni.Fit for the temporary management of stress urinary incontinence (SUI) in women.
- Trial name
- NCT03978741
- Testing
- Yōni.Fit Test Device, Yōni.Fit Comparator Device
- Where
- 3 sites in United States
- Volunteers
- 80 people
- Sponsor
- Watkins Conti Products. Inc.
Faecal Incontinence, Chronic Constipation
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
This clinical investigation is a post-market, exploratory, randomised, parallel, open-label investigation comparing two UKCA/CE-marked transanal irrigation products for the management of faecal incontinence and/or chronic…
- Trial name
- ORBIT-1 (NCT07473622)
- Testing
- Transanal irrigation
- Where
- United Kingdom
- Volunteers
- 66 people
- Sponsor
- Qufora A/S
Stress Urinary Incontinence
Intraurethral/Intravaginal 2940 Nm Erbium Laser Treatment for Stress Urinary Incontinence
Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence.
- Trial name
- NCT03676894
- Testing
- Intravaginal Fotona SP Dynamis, Intraurethral Fotona SP Dynamis
- Where
- 2 sites in Canada
- Volunteers
- 55 people
- Sponsor
- Fotona d.o.o.
Stress Urinary Incontinence
A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.
- Trial name
- NCT02160314
- Testing
- pessary, Absorbent pad
- Where
- United States
- Volunteers
- 224 people
- Sponsor
- Procter and Gamble
Urinary Incontinence
Exploratory Study of a New Urine Collection Device for Men
The aim of the investigation is to evaluate the subjects experience of a new collection device for men. An open-labelled, single arm study design was chosen for this investigation with a duration of 1 week + up to 3 days extra.
- Trial name
- NCT04672993
- Testing
- Urine collection device for men
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Coloplast A/S
Stress Urinary Incontinence
LIBERATE International
This is a prospective, randomized, double-blind, sham-controlled clinical study. The study is designed to demonstrate that active is superior to sham for the efficacy endpoints and is deemed to have appropriate safety as compared…
- Trial name
- NCT03619174
- Testing
- Viveve Treatment
- Where
- 6 sites in Canada
- Volunteers
- 99 people
- Sponsor
- Viveve Inc.
Overactive Bladder (OAB)
A Phase II Study of KUC-7483 in Patients With Overactive Bladder
To investigate the efficacy and safety of KUC-7483 in overactive bladder patients.
- Trial name
- NCT00742833
- Testing
- KUC-7483
- Where
- 6 sites in Japan
- Volunteers
- 400 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Vaginal Atrophy, Vulvovaginal Signs and Symptoms
Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.
The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMG-23-04-2019" on the female genital area for the medicinal…
- Conditions
- Vaginal Atrophy, Vulvovaginal Signs and Symptoms, Dyspareunia, Urinary Incontinence
- Trial name
- NCT04659668
- Testing
- MMG-23-04-2019
- Where
- Bulgaria
- Volunteers
- 37 people
- Sponsor
- Mesoestetic Pharma Group S.L.
Urinary Incontinence, Overactive Bladder
A Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in India
This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive…
- Trial name
- NCT02590250
- Testing
- botulinum toxin Type A
- Where
- 12 sites in India
- Volunteers
- 250 people
- Sponsor
- Allergan
Faecal Incontinence
Safety and Tolerability of the Twice Daily Intra-anal Application of NRL001 Cream for 14 Days
The study is being conducted to evaluate the safety and tolerability after single and repeated twice daily intra-anal applications of 1mL NRL001 cream in stepwise increasing concentrations.
- Trial name
- NCT06593730
- Testing
- NRL001 cream 0.5%w/w, NRL001 cream 0.75%w/w, NRL001 cream 1.0%w/w
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Norgine
Urological
Feasibility Assessment of ACS Catheter
This is a single centre, non-randomised, baseline controlled, prospective pilot clinical trial to be undertaken at Rotherham General Hospital, Rotherham, UK.
- Trial name
- ACS1 (NCT01960517)
- Testing
- ACS Catheter
- Where
- United Kingdom
- Sponsor
- Alternative Urological Catheter Systems Ltd.
Overactive Bladder
A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).
- Trial name
- NCT00928070
- Testing
- Fesoterodine
- Where
- 125 sites in United States
- Volunteers
- 566 people
- Sponsor
- Pfizer
Overactive Bladder
Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.
- Trial name
- NCT00910520
- Testing
- onabotulinumtoxinA, normal saline
- Where
- 7 sites in United States, Belgium and 5 more
- Volunteers
- 548 people
- Sponsor
- Allergan
Stress Urinary Incontinence
Use of the Leva Incontinence System in Treating Bladder Incontinence.
This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period.
- Trial name
- NCT03536923
- Testing
- Leva Incontinence System For Pelvic Floor Muscle strengthening
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Renovia, Inc.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the…
- Conditions
- Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause, Quality of Life
- Trial name
- STOPGSMP (NCT06962345)
- Testing
- Hormone-free vulvovaginal gel with the tested composition XCMIM20m
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- Mucosa Innovations, S.L.
Urinary Incontinence
Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and…
- Trial name
- NCT00196404
- Testing
- DR-3001a, DR-3001b
- Where
- 48 sites in United States, Canada
- Volunteers
- 800 people
- Sponsor
- Duramed Research