Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence

Recruiting now · Not applicable

Conditions studied: Fecal Incontinence

In brief

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.

Key facts

Study ID

NCT07604415

Run by

University Hospital, Martin

People needed

24

Starts

2026-05-15

Expected to finish

2029-05-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 (>120° on ultrasound) requiring surgical repair
• Isolated severe rectal sensory dysfunction without significant sphincter dysfunction
• Previous pelvic radiotherapy
• Concurrent participation in another interventional clinical trial

Where it is running

• Clinic of Internal Medicine- Gastroenterology, University Hospital Martin — Martin, Slovakia (enrolling)

Full record on ClinicalTrials.gov

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