Clinical trials: Anal Incontinence
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
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
Fecal Incontinence
Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
The purpose of this study is to evaluate the safety, efficacy, and functionality of the Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal incontinence.
- Trial name
- NCT02208258
- Testing
- Consure 120 Stool Management System
- Where
- United States
- Sponsor
- Consure Medical Pvt. Ltd.
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
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
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
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
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
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
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.
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.
Incontinence
Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects
This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. A screening will be used to determine subject suitability for inclusion in the trial.
- Trial name
- NCT00972998
- Testing
- Phenyephrine
- Where
- Israel
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- RDD Pharma Ltd
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.
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 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
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
A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence
The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women.
- Trial name
- NCT00762047
- Testing
- Durasphere FI
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Carbon Medical Technologies
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
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
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