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Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence

NCT07604415 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Fecal Incontinence

Interventions

DEVICE

Home-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.

Sponsors & Collaborators

  • Comenius University

    collaborator OTHER

  • University Hospital, Martin

    lead OTHER

Principal Investigators

  • Peter Liptak, MD, PhD · Clinic of Internal Medicine- Gastroenterology, University Hospital Martin, Jessenous Faculty of Medicine in Martin, Comenius University, Slovakia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2029-05-31
Completion
2029-05-31

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07604415 on ClinicalTrials.gov