Clinical trials: Incontinence Bowel
Fecal Incontinence
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
- Trial name
- TRANSFORM (NCT01090739)
- Testing
- TOPAS Treatment for Fecal Incontinence
- Where
- 14 sites in United States
- Volunteers
- 207 people
- Sponsor
- ASTORA Women's Health
Incontinence, Urinary, Incontinence, Fecal
Testing the Protective and Caring Effect of a Water-in-oil Formulation in Patients Suffering From Urinary and/or Fecal Incontinence and Requiring Incontinence Care Products
The aim of this study is to test the protecting and caring effect of a protective balm on patients suffering from urinary and/or fecal incontinence and need incontinence care products.
- Trial name
- NCT06924502
- Testing
- Protective Balm
- Where
- Germany
- Volunteers
- 33 people
- Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
Bowel Incontinence
A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage
The purpose of this study is to determine whether the use of the Renew Insert is effective, tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.
- Trial name
- REST (NCT01475474)
- Testing
- Renew Insert
- Where
- 3 sites in United States
- Volunteers
- 97 people
- Sponsor
- Renew Medical
Urinary Retention, Urinary Urge Incontinence
Axonics SacRal NeuromodulaTIon System RegisTRY Study
To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).
- Conditions
- Urinary Retention, Urinary Urge Incontinence, Urgency-Frequency, Fecal Incontinence
- Trial name
- ARTISTRY (NCT05064384)
- Where
- 27 sites in United States, Canada
- Volunteers
- 272 people
- Sponsor
- Axonics, Inc.
Neurogenic Bowel (Disorder), Fecal Constipation
Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis
A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis…
- Conditions
- Neurogenic Bowel (Disorder), Fecal Constipation, Fecal Incontinence, Multiple Sclerosis
- Trial name
- NCT04707976
- Testing
- Navina Smart, Standard Bowel Care
- Where
- 9 sites in Denmark, France and 4 more
- Volunteers
- 92 people
- Sponsor
- Wellspect HealthCare
Fecal Incontinence
Safety and Effectiveness Evaluation of the ForConti Fecal Management System - Pilot Study
The ForConti Fecal Incontinence Management System (FIMS) is indicated for the management of accidental bowel leakage due to bowel incontinence.
- Trial name
- NCT02865291
- Testing
- ForConti device
- Volunteers
- 20 people
- Sponsor
- ForConti Medical
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
Faecal Incontinence
A Multi-centre, Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose-ranging Study in Patients With Faecal Incontinence; to Evaluate the Efficacy, Safety and Tolerability of Locally Applied NRL001 Over an 8 Week Treatment Period
The purpose of this study is to evaluate the safety, tolerability and efficacy of NRL001 in the treatment of faecal incontinence, compared against placebo
- Trial name
- NCT01656720
- Testing
- 1R, 2S-methoxamine hydrochloride
- Where
- 51 sites in Czechia, France and 7 more
- Volunteers
- 417 people
- Sponsor
- Norgine
Dermatitis
A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)
The purpose of this study is to obtain information concerning the safety and effective use of a protective barrier film in patients experiencing severe incontinence associated dermatitis.
- Trial name
- NCT02724449
- Testing
- Cavilon Advanced Barrier Film
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Solventum US LLC
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.
Fecal Incontinence
Intra-anal Oxymetazoline in Healthy Adult Volunteers
This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety, tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal application.
- Trial name
- NCT03529487
- Testing
- Oxymetazoline
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- RDD Pharma Ltd
Fecal Incontinence
Effects of an Anal Insert Device in Fecal Incontinence
The purpose of this research is to test the effects of an inserted anal device on fecal incontinence (accidental bowel leakage) in patients who have persistent symptoms despite other conservative therapy.
- Trial name
- NCT03898778
- Testing
- Minnesota Medical Technologies Anal Insert Device
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Minnesota Medical Technologies
Fecal Incontinence
Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)
The ForConti Contix Fecal Incontinence Management System (FIMS) is indicated for the management of accidental bowel leakage due to bowel incontinence.
- Trial name
- NCT03813251
- Testing
- ForConti Contix Fecal Incontinence Management System (FIMS)
- Volunteers
- 30 people
- Sponsor
- ForConti Medical
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
Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence
- Trial name
- TOPAS (NCT00565136)
- Testing
- TOPAS
- Where
- 5 sites in United States
- Volunteers
- 29 people
- Sponsor
- ASTORA Women's Health
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
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
Fecal Incontinence
Feasibility Study of the Use of the gekoTM Device for Faecal Incontinence in Older People Living at Home or in Care Homes
This research aims to investigate the feasibility for the treatment of OnPulse(TM) for the treatment of faecal incontinence (FI) (including mixed faecal and urinary incontinence) in older people living at home or in a Care Home.
- Trial name
- NCT02875665
- Testing
- geko(TM) device
- Where
- United Kingdom
- Volunteers
- 13 people
- Sponsor
- Firstkind Ltd
Fecal Incontinence
Study to Evaluate Solesta for Treatment of Fecal Incontinence
The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in the treatment of fecal incontinence for a total of 24 months after completed treatment.
- Trial name
- NCT01110681
- Testing
- Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)
- Where
- 15 sites in Canada, Finland and 5 more
- Volunteers
- 115 people
- Sponsor
- Galderma R&D
Fecal Incontinence
Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum
Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when administered as a slow release suppository applied to the anal canal or rectum.
- Trial name
- NCT00893607
- Testing
- NRL001
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Norgine