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.
• Signed informed consent
• Age ≥18 years
• Diagnosis of fecal incontinence (urge, passive, or mixed type) with at least 1 episode of involuntary stool leakage requiring hygiene intervention or underwear change per month for ≥3 months
• Vaizey (St. Mark's) Incontinence Score ≥8
• Ability to understand study procedures and comply with the 12-week home intervention
• Willingness to attend all study visits and assessments
• Stable medical management for fecal incontinence for at least 4 weeks prior to enrollment