Clinical trials: Bowel 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
Fecal Incontinence, Bowel Dysfunction
LIBERATE - PRO: Eclipse™ System Registry
A prospective, open label post market registry to collect Patient Reported Outcomes in an online data capture registry, maintained by Pelvalon, of women with fecal incontinence exiting the LIBERATE study (NCT02428595) continuing…
- Conditions
- Fecal Incontinence, Bowel Dysfunction, Bowel Incontinence, Accidental Bowel Leakage
- Trial name
- LIBERATEPRO (NCT03028636)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Pelvalon, 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
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
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
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
Pursuit: Real World Use of the Eclipse System
A prospective, open label post-market registry to collect Patient Reported Outcomes and Fitting metrics (e.g. sizes used) in subjects using the Eclipse System in a commercial setting.
- Trial name
- PURSUIT (NCT03940573)
- Testing
- Eclipse Insert
- Where
- 6 sites in United States
- Volunteers
- 150 people
- Sponsor
- Pelvalon, Inc.
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
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
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
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
Urinary Incontinence, Fecal Incontinence
Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)
This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number…
- Conditions
- Urinary Incontinence, Fecal Incontinence, Urge Incontinence, Nocturia
- Trial name
- NCT05368246
- Testing
- UCon
- Where
- 3 sites in Denmark
- Volunteers
- 80 people
- Sponsor
- InnoCon Medical
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
Fecal Incontinence
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.
- Trial name
- NCT05708612
- Testing
- Medical Device (SimplyFI)
- Where
- 5 sites in Austria, Germany and 1 more
- Volunteers
- 36 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Fecal Incontinence
Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of a Single Rectal Application of 10 mg NRL001 in Elderly Subjects
A total of 26 healthy elderly male and female subjects will receive both 10 mg NRL001 in a 2 g rectal suppository and placebo in this double-blind, cross-over study.
- Trial name
- NCT01099683
- Testing
- NRL001
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Norgine
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
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
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
Urinary Incontinence, Urinary Incontinence, Urge
Safety and Performance of UCon Patch Electrode
UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder/bowel musculature e.g.…
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge, Nocturia, Urinary Frequency More Than Once at Night
- Trial name
- NCT06754189
- Testing
- Time Limited stimulation
- Where
- 3 sites in Denmark
- Volunteers
- 180 people
- Sponsor
- InnoCon Medical
Fecal Incontinence
Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence
Pilot study to understand the impact of a digital health system, including a phone app and a vaginal probe to treat fecal incontinence in women
- Trial name
- NCT04027335
- Testing
- leva
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Renovia, Inc.