RecruitingNot ApplicableNCT07604415

Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence

Sponsor

University Hospital, Martin

Enrollment

24 participants

Start Date

May 15, 2026

Study Type

INTERVENTIONAL

Conditions

Fecal Incontinence

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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

Exclusion Criteria18

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

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Interventions

DEVICEHome-based anal electrical stimulator

Home-based anal electrical stimulation delivered using the NeuroTrac Continence device. Stimulation parameters include frequency 40 Hz, pulse width 250 µs, 5 seconds ON and 10 seconds OFF cycles, 1-second ramp-up, session duration 25 minutes, and patient-adjusted intensity up to the maximum tolerable level without pain.