Condition: Fecal Incontinence · Sponsor: University Hospital, Martin
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.
This description comes directly from the study's public registry record.
Peter Liptak, MD, PHD · +421904820189 · peter.liptak@gmail.com
Adam Lukac, MD · adamlukac99@gmail.com
Always discuss trial participation with your own doctor first.
| Clinic of Internal Medicine- Gastroenterology, University Hospital Martin | Martin, Slovakia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07604415