Clinical trials: Fecal Incontinence
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
- Volunteers
- 66 people
- Sponsor
- Qufora A/S
Fecal Incontinence
A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use.
- Trial name
- LIBERATE (NCT02428595)
- Testing
- Eclipse™ System
- Where
- 11 sites in United States
- Volunteers
- 137 people
- Sponsor
- Pelvalon, Inc.
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
Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction…
- Trial name
- Fidelia (NCT04976153)
- Testing
- aSMDC
- Where
- 34 sites in Austria, Bulgaria and 10 more
- Volunteers
- 290 people
- Sponsor
- Innovacell GmbH
Fecal Incontinence
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place.
- Trial name
- NCT00200057
- Testing
- InterStim Sacral Nerve Stimulation Therapy
- Where
- 13 sites in United States, Canada
- Volunteers
- 285 people, healthy volunteers welcome
- Sponsor
- MedtronicNeuro
Fecal Incontinence
Feasibility Study of the Magnetic Anal Sphincter (FENIX System)
The purpose of this feasibility study is to obtain preliminary safety and effectiveness information and develop procedural optimization for the Magnetic Anal Sphincter device (FENIX System) in reinforcement of anal sphincter…
- Trial name
- NCT01625221
- Testing
- Magnetic Anal Sphincter
- Where
- 4 sites in United States, Denmark and 1 more
- Volunteers
- 35 people
- Sponsor
- Torax Medical Incorporated
Fecal Incontinence, Faecal Incontinence
FENIX™ Continence Restoration System Registry
The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative…
- Trial name
- NCT04007250
- Testing
- FENIX™ Continence Restoration System
- Where
- 2 sites in France, Germany
- Volunteers
- 94 people
- Sponsor
- Torax Medical Incorporated
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
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
Faecal Incontinence
The Safety and Dose Response to Single Anal Doses of NRL001
Single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP).
- Trial name
- NCT06593743
- Testing
- Perianal NRL001 Gel 3 strengths, Intraanal NRL001 Gel 2 strengths, Intrarectal NRL001 Gel
- Where
- United Kingdom
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Norgine
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
Faecal Incontinence, Faecal Incontinence With Faecal Urgency
UCon Treatment of the Symptoms of Faecal Incontinence (FI)
UCon is a medical device for treatment of the symptoms of overactive bladder and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g.…
- Trial name
- NCT05864807
- Testing
- UCon
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- InnoCon Medical
Faecal Incontinence
A Study to Evaluate Topical Phenylephrine Gel in the Management of Faecal Incontinence
The aim of the study is to test the hypothesis that topical application of phenylephrine improves faecal continence and quality of life in subjects with passive faecal incontinence after ileo-anal pouch construction.
- Trial name
- NCT00420797
- Testing
- 10% Phenylephrine hydrochloride gel
- Where
- United Kingdom
- Sponsor
- S.L.A. Pharma AG
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
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.
Fecal Incontinence
Effect of 7 Days of Dosing With a 10 mg Rectal Suppository of NRL001in Patients With Faecal Incontinence
This is a study to examine the effect of alpha adrenergic stimulation of the anal canal and rectum on parameters affecting the control of defecation in subjects with faecal incontinence.
- Trial name
- NCT01175941
- Testing
- NRL001
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- Norgine
Fecal Incontinence
Safety Study of Autologous Cultured Adipose -Derived Stem Cells for the Fecal Incontinence
Fecal incontinence affects 18.4% adults in the community and greatly impacts quality of life. There's a problem like inconvenience, pain or allergic response in many therapeutic methods such as a surgical operation or material…
- Trial name
- NCT01011686
- Testing
- ANT-SM
- Where
- South Korea
- Sponsor
- Anterogen Co., Ltd.
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, Tolerability, Pharmacodynamic and Pharmacokinetics of 7.5, 10, 12.5 or 15 mg NRL001 in a 2 g Suppository for 14 Days
Healthy subjects will receive NRL001 or placebo once daily for 14 days. The four treatment groups, shown below, will each consist of 12 subjects: Group 1; Nine subjects will receive a dose of 7.5 mg NRL001 in a 2 g suppository…
- Trial name
- NCT01099670
- Testing
- NRL001
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Norgine
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