Clinical trials: Fecal Incontinence
Fecal Incontinence (FI)
Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence
The purpose if this interventional First in Human study is to assess the Safety and Performance of the ALVIV System laser based treatment in patients diagnosed with Fecal Incontinence.
- Trial name
- NCT07436676
- Testing
- ALVIV Laser Treatment
- Where
- Israel
- Volunteers
- 12 people
- Sponsor
- Alviv Ltd.
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.
Fecal Incontinence
Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
The purpose of this observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.
- Trial name
- SoFI (NCT01647906)
- Where
- 20 sites in United States
- Volunteers
- 277 people
- Sponsor
- Bausch Health Americas, 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
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
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
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
- Conditions
- Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI), Overactive Bladder (OAB)
- Trial name
- NCT07335484
- Testing
- Axonics External Trial System (ETS)
- Where
- 5 sites in United States, Australia
- Volunteers
- 75 people
- Sponsor
- Axonics, Inc.
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.
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
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
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
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
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
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.
Fecal Incontinence
Intra-anal Oxymetazoline in Healthy Adult Volunteers
This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety, tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal application.
- Trial name
- NCT03529487
- Testing
- Oxymetazoline
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- RDD Pharma Ltd
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
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
Incontinence, Urinary, Incontinence, Fecal
Testing the Protective and Caring Effect of a Water-in-oil Formulation in Patients Suffering From Urinary and/or Fecal Incontinence and Requiring Incontinence Care Products
The aim of this study is to test the protecting and caring effect of a protective balm on patients suffering from urinary and/or fecal incontinence and need incontinence care products.
- Trial name
- NCT06924502
- Testing
- Protective Balm
- Where
- Germany
- Volunteers
- 33 people
- Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
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
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