Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence

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.

NCT Number	NCT07604415
Lead Sponsor	University Hospital, Martin Collaborators: Comenius University
Conditions	Fecal Incontinence
Enrollment	24 participants
Start Date	2026-05-15
Primary Completion	2029-05 (estimated)
Study Completion	2029-05 (estimated)
Updated on ClinicalTrials.gov	2026-05-28