AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Martin
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Signed informed consent * Age โ‰ฅ18 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 โ‰ฅ3 months * Vaizey (St. Mark's) Incontinence Score โ‰ฅ8 * 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 Exclusion Criteria: * Complete spinal cord injury above the conus medullaris * Active inflammatory bowel disease flare requiring systemic therapy or not in clinical remission * Rectal prolapse requiring surgical intervention * Severe symptomatic hemorrhoids interfering with anorectal assessments or device use * Active anal fissure or perianal fistula * Active colorectal cancer or history of colorectal cancer within 5 years * Colorectal surgery within the previous 6 months * Pregnancy or planned pregnancy during study participation * Implanted cardiac pacemaker or defibrillator * Other implanted electrical devices contraindicating electrical stimulation * Previous specialized pelvic floor physiotherapy, biofeedback therapy, EMG-guided rehabilitation, or anal electrical stimulation within 3 months prior to randomization * Cognitive impairment preventing understanding of study procedures or informed consent * Uncontrolled severe diarrhea (\>5 liquid stools/day) * Anal stenosis preventing probe insertion * Severe anal sphincter defect (\>120ยฐ on ultrasound) requiring surgical repair * Isolated severe rectal sensory dysfunction without significant sphincter dysfunction * Previous pelvic radiotherapy * Concurrent participation in another interventional clinical trial
๐Ÿ’Š

What it tests

  • Home-based anal electrical stimulator
๐Ÿ“

Where

1 site
Clinic of Internal Medicine- Gastroenterology, University Hospital Martin
Martin, Slovakia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy