Comparing Home-Based Active Anal Electrical Stimulation With Passive Stimulation Alone for Adults With Fecal Incontinence

What this Trial Is About

This research aims to evaluate treatments for adults with fecal incontinence, a condition that significantly affects quality of life. The trial compares whether home-based anal electrical stimulation combined with active voluntary anal sphincter contraction is more effective than electrical stimulation alone. It is a prospective, randomized, parallel-group, open-label controlled trial enrolling patients with urge, passive, or mixed fecal incontinence. Participants are randomly assigned to one of two groups. The active group uses a NeuroTrac Continence device to deliver electrical stimulation while performing synchronized voluntary anal sphincter contractions during stimulation cycles. The control group receives the same electrical stimulation but remains relaxed without active contractions. Both groups receive standardized education and device training for a 12-week intervention period. Participants will be assessed at the start, after 12 weeks of treatment, and again at 36 weeks for follow-up. Evaluations include the VaizeySt. Marks Incontinence Score, quality of life scales, a 14-day bowel diary, anorectal manometry, adherence tracking, and safety monitoring. Optional ultrasound may be performed if clinically indicated. The main measure is change in incontinence score at 12 weeks, with additional outcomes such as episode frequency, manometry parameters, treatment adherence, adverse events, and sustained response over time.

Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence