Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence
NCT: NCT07604415 · RECRUITING
Brief Summary
Fecal incontinence is a disabling condition that can substantially impair quality of life. This study evaluates whether home-based anal electrical stimulation combined with active voluntary anal sphincter contraction is superior to electrical stimulation alone in patients with fecal incontinence. The study is a prospective, randomized, parallel-group, open-label controlled trial. Participants will be randomized in a 1:1 ratio to either electrical stimulation with synchronized active sphincter contraction or electrical stimulation alone. The primary outcome is the change in Vaizey/St. Mark's Incontinence Score from baseline to week 12. Secondary outcomes include fecal incontinence episodes, quality of life, anorectal manometry parameters, adherence, safety, and sustained response during follow-up.
Frequently Asked Questions
What is Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence?
Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence is a clinical trial registered under NCT07604415. Current status: RECRUITING.
What is the status of NCT07604415?
The current status of NCT07604415 (Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence) is: RECRUITING.
When did Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence start?
Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence started on 2026-05-15.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.