Fecal Incontinence Clinical Trial
Official title:
Neuromodulation for Accidental Bowel Leakage
This study is a multi-center, randomized clinical trial of women with refractory accidental bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2 first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal incontinence (FI) in women. The investigators will test the null hypothesis that change from baseline in St. Mark's (Vaizey) score after 12 weeks of stimulation is not significantly different in women with symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.
The overarching goal of this randomized clinical trial is to determine if PTNS is more effective than sham PTNS for the treatment of FI in women after 12 weeks of treatment and 1 year after initiating treatment. This is a two-part trial with a Run-In Phase prior to randomization. The trial has the following primary aim: To determine whether the change from baseline in St. Mark's (Vaizey) score in women with symptomatic ABL undergoing PTNS differs from sham after 12 weeks of stimulation. Additional secondary aims include: 1. To compare changes from baseline in self-reported functional outcomes after 12 weekly stimulation sessions in both PTNS and sham groups in Part 1. 2. To determine whether symptom relief amongst study "responders" can be sustained for one year with maintenance treatments in Part II. 3. To determine the impact of completing a bowel diary and receiving education on FI on symptom severity. 4. To determine the ability of the PFDN ABL phone app bowel diary to detect changes from baseline in fecal incontinence episodes recorded to after 12 weeks of stimulation sessions. 5. To determine the association between St. Mark's score and both fat and fiber intake alone and in combination. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03825575 -
Sacral Neuromodulation as Treatment for Fecal Incontinence
|
N/A | |
Completed |
NCT00605826 -
A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
|
N/A | |
Withdrawn |
NCT02208258 -
Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
|
N/A | |
Completed |
NCT01957969 -
French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence
|
N/A | |
Completed |
NCT01939821 -
A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes
|
N/A | |
Completed |
NCT01710579 -
Normal Values in Ano-rectal 3D High Resolution Manometry
|
N/A | |
Recruiting |
NCT00530933 -
Tibial Nerve Stimulation for Faecal Incontinence
|
N/A | |
Completed |
NCT00565136 -
Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
|
Phase 1/Phase 2 | |
Withdrawn |
NCT00522691 -
Efficacy of Sacral Nerve Stimulation Before Definitive Implantation
|
N/A | |
Completed |
NCT00677508 -
Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
|
||
Completed |
NCT05032534 -
Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
|
N/A | |
Completed |
NCT05058326 -
Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
|
||
Completed |
NCT03746834 -
NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation
|
Phase 4 | |
Completed |
NCT00124904 -
Biofeedback for Fecal Incontinence
|
N/A | |
Completed |
NCT03028636 -
LIBERATE - PRO: Eclipseâ„¢ System Registry
|
||
Completed |
NCT04097288 -
Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects
|
Phase 1 | |
Completed |
NCT05621629 -
Management of FI After Surgery of ARM
|
||
Withdrawn |
NCT04138602 -
BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence
|
N/A | |
Completed |
NCT04478799 -
Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience
|
N/A | |
Completed |
NCT03252951 -
Physical Therapy for Anal Incontinence
|
N/A |