Clinical trials: Fecal Incontinence
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
Overactive Bladder, Urge Incontinence
Lidocaine Patches Prior to Percutaneous Nerve Evaluation
The study will be a double-blind randomized control trial comparing 4% lidocaine patch placed over the sacrum 3 minutes prior to a percutaneous nerve evaluation (PNE) procedure to a placebo patch in patients already scheduled to…
- Conditions
- Overactive Bladder, Urge Incontinence, Fecal Incontinence
- Trial name
- NCT05783219
- Testing
- Lidocaine patch
- Where
- 2 sites in United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University of Louisville
Fecal Incontinence, Neurogenic Bowel
A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children
There is a surgical procedure to help children with intractable fecal incontinence gain continence for stool through construction of a tube that connects the abdominal wall to the colon near or through the appendix.
- Trial name
- NCT02435069
- Testing
- Dose Response - NS and USP Glycerin - First Intervention, Effectiveness - NS and USP Glycerin - Second Intervention
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Nemours Children's Clinic
Constipation, Fecal Incontinence
Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
The aim of this study is to determine the success rate, the success duration, the complication rate, maintenance effort and quality of life several years after sacral nerve modulation (SNM) treatment for constipation or stool…
- Trial name
- NCT02836717
- Testing
- sacral nerve modulation
- Volunteers
- 101 people
- Sponsor
- Cantonal Hospital of St. Gallen
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.
Constipation, Fecal Incontinence
A Colonic Tube to Improve Bowel Function in Spinal Cord Injury
The investigators want to know if placing a tube through the skin and into the colon to flush out the colon is safe and effective in helping spinal cord Veterans with bowel management.
- Conditions
- Constipation, Fecal Incontinence, Spinal Cord Injury
- Trial name
- NCT00345397
- Testing
- Percutaneous endoscopic colostomy (PEC) tube
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- VA Office of Research and Development
Low Anterior Resection Syndrome, Malignant Anal Neoplasm
Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study
This phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to…
- Conditions
- Low Anterior Resection Syndrome, Malignant Anal Neoplasm, Malignant Bladder Neoplasm, Malignant Cervical Neoplasm
- Trial name
- NCT04066894
- Testing
- Explantation, Quality-of-Life Assessment, Questionnaire Administration
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- M.D. Anderson Cancer Center
Fecal Incontinence, Bowel Incontinence
Fecal Incontinence Treatment (FIT) Study
Patients with severe fecal incontinence (FI), defined as two or more episodes of staining, solid or liquid FI per week, and who meet the inclusion criteria for Injection of Solesta (INJ; an inert bulking agent), or Biofeedback…
- Trial name
- NCT03811821
- Testing
- Biofeedback, Injection
- Where
- 6 sites in United States
- Volunteers
- 275 people
- Sponsor
- Mayo Clinic
Fecal Incontinence
A Placebo-Controlled Study of Clonidine for Fecal Incontinence.
Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic are doing a research study to assess the effects of a medication, clonidine, on fecal incontinence and rectal functions in women.
- Trial name
- NCT00884832
- Testing
- Clonidine
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Mayo Clinic
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
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
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
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
Overactive Bladder, Urinary Incontinence
Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
The investigators propose a randomized control trial comparing the rate of implantation of the InterStim device following Percutaneous Nerve Evaluation (PNE) performed with or without fluoroscopic guidance.
- Conditions
- Overactive Bladder, Urinary Incontinence, Fecal Incontinence
- Trial name
- NCT02677753
- Testing
- Fluoroscopy
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- University of Louisville
Fecal Incontinence
Educational-Medical-Behavioral Treatment of Fecal Incontinence
In previous studies at a university referral center the investigators demonstrated that a multicomponent conservative treatment for fecal incontinence was effective.
- Trial name
- FIX (NCT01717456)
- Testing
- Education, Fiber supplements, Laxatives or anti-diarrheals
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of North Carolina, Chapel Hill
Fecal Incontinence
Prevalence and Treatment of Anal Incontinence (AI) in Primiparous Women
Traumatic tears of the sphincter ani muscles after delivery may result in symptomatic urinary and anal incontinence, particularly in primiparas.
- Trial name
- NCT00970320
- Testing
- Pelvic floor muscle training
- Where
- Norway
- Volunteers
- 1,718 people, healthy volunteers welcome
- Sponsor
- Ostfold Hospital Trust
Fecal Incontinence
A Feasibility Study of a Fecal Incontinence Management System for Medical Use
The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System.
- Trial name
- NCT00556972
- Testing
- Fecal Incontinence Management System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Coloplast A/S
Fecal Incontinence
The Use of an "Anal-Tape" in Patients With Fecal Incontinence
Fecal incontinence (FI), defined as the involuntary passage of stool for more than 3 months and is a devastating disease. The negative impact on quality of life has been consistently demonstrated.
- Trial name
- NCT02989545
- Testing
- Anal Tape
- Volunteers
- 20 people
- Sponsor
- Shaare Zedek Medical Center
Fecal Incontinence
A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)
The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.
- Trial name
- LIFE (NCT01655498)
- Testing
- vaginal bowel control system (LivSure)
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Pelvalon, Inc.