Clinical trials: Anal Incontinence
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
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
Idiopathic Fecal Incontinence
A Double Blinded Study to Examine the Effect of Alpha Agonist Ointment on Fecal Incontinence in Patients With Idiopathic Fecal Incontinence
The purpose of this study is to assess the effect and safety of alpha agonist ointment on fecal incontinence severity in patients with idiopathic fecal incontinence.
- Trial name
- NCT01421823
- Testing
- alpha agonist ointment
- Where
- Israel
- Sponsor
- RDD Pharma Ltd
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
Complex Anal Fistulas
Fistura® Procedure for the Treatment of Complex Anal Fistulas
This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.
- Trial name
- NCT06113068
- Testing
- Fistura® procedure
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- F Care Systems NV
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
French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence
The aim of this observational study is to evaluate the utilization in the clinical practice, effectiveness, explantation and re-intervention rate, complications and adverse events of InterStim system in patients indicated to…
- Trial name
- NCT01957969
- Testing
- Sacral Nerve Stimulation
- Where
- 16 sites in France
- Volunteers
- 234 people
- Sponsor
- MedtronicNeuro
Urinary Incontinence, Urinary Incontinence, Urge
Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)
UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature…
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge, Fecal Incontinence, Fecal Incontinence With Fecal Urgency
- Trial name
- NCT06091566
- Testing
- UCon-Bar
- Where
- 3 sites in Denmark
- Volunteers
- 20 people
- Sponsor
- InnoCon Medical
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
Fecal Incontinenece
A Double Blinded Study to Examine the Effect of Coated Suppositories on Fecal Incontinence in Patients With Spinal Cord Injury
This is a double blinded cross over study. Approximately 20 spinal cord injury patients will be participating in this 4 weeks study.The primary outcome is difference in fecal incontinence as recorded in diaries, between the…
- Trial name
- NCT01297608
- Testing
- caoted suppository, coated suppository
- Where
- Israel
- Sponsor
- RDD Pharma Ltd
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
A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence.
- Trial name
- NCT00605826
- Testing
- NASHA/Dx (Solesta) Gel
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 206 people
- Sponsor
- Bausch Health Americas, Inc.
Fecal Incontinence
Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence
This is first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed…
- Trial name
- NCT05616208
- Testing
- Bioengineered Internal Anal Sphincter
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cellf Bio LLC
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
Chronic Constipation
To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.
The purpose of this study is to determine whether Forlax® is more effective than placebo in relieving chronic constipation in children who may also suffer from soiling or faecal incontinence.
- Trial name
- NCT00255372
- Testing
- PEG 4000 (Forlax®)
- Where
- 2 sites in Thailand
- Volunteers
- 88 people
- Sponsor
- Ipsen
Fecal Incontinence
Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal…
- Trial name
- NCT01666405
- Testing
- Urgent(R) PC Neuromodulation System
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Uroplasty, Inc
Fecal Incontinence
Study to Investigate Safety and Response to 1 or 2 g Rectal Suppositories Containing 5 or 10 mg NRL001.
This is a healthy volunteer three-way crossover study. A total of 12 subjects will receive three single administrations of 1 g rectal suppositories (containing either 5 mg NRL001, 10 mg NRL001 or matching placebo), with a washout…
- Trial name
- NCT00857467
- Testing
- NRL001
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Norgine
Fecal Incontinence
An Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects
This is an open label, dose-finding, 2-parts study. Approximately 6 subjects will be participating in this study. This study is composed of 2 parts: Part 1 is a dose finding study.
- Trial name
- NCT01265485
- Testing
- coated suppository
- Where
- Israel
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- RDD Pharma Ltd
Urinary Incontinence, Fecal Incontinence
Incontinence Management System ICU Field Evaluation
The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System.
- Trial name
- NCT03628833
- Testing
- Incontinence Management System
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hill-Rom
Fecal Incontinence, Spinal Cord Injury
The Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on anal resting pressure and fecal incontinence in patients with spinal cord injury.
- Trial name
- NCT02299557
- Testing
- Oxymetazoline gel
- Where
- Hungary
- Volunteers
- 19 people
- Sponsor
- RDD Pharma Ltd