Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence

NCT07604415 | Recruiting

• 1 other identifier: EK38/2026
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fecal incontinence; anal stimulation; pelvic floor training

Outcome Measures

Primary Outcomes (1)

• Change in Vaizey (St. Mark's) Incontinence Score From Baseline to Week 12

  Mean change in Vaizey (St. Mark's) Incontinence Score between baseline and week 12. The Vaizey score ranges from 0 to 24, with higher scores indicating more severe fecal incontinence symptoms.

  Baseline to Week 12

Secondary Outcomes (9)

• Change in Weekly Fecal Incontinence Episodes From Baseline to Week 12

  Baseline to Week 12

• Proportion of Participants Achieving ≥30% Reduction in Vaizey Score at Week 12

  Week 12

• Sustained Improvement in Vaizey Score at Week 36

  Baseline to Week 36

• Change in Maximum Squeeze Pressure on High-Resolution Anorectal Manometry

  Baseline to Week 12

• Change in Resting Anal Pressure on High-Resolution Anorectal Manometry

  Baseline to Week 12

Study Arms (2)

Electrical Stimulation + Active Contraction

ACTIVE COMPARATOR

Home-based anal electrical stimulation combined with synchronized active voluntary anal sphincter contraction for 12 weeks

Device: Home-based anal electrical stimulator

Electrical Stimulation Alone

ACTIVE COMPARATOR

Home-based anal electrical stimulation alone without active voluntary sphincter contraction for 12 weeks.

Device: Home-based anal electrical stimulator

Interventions

Home-based anal electrical stimulator DEVICE

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.

Electrical Stimulation + Active Contraction; Electrical Stimulation Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospital, Martin: lead
• Comenius University: collaborator

Study Sites (1)

Clinic of Internal Medicine- Gastroenterology, University Hospital Martin

Martin, 03601, Slovakia

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Peter Liptak, MD, PhD

  Clinic of Internal Medicine- Gastroenterology, University Hospital Martin, Jessenous Faculty of Medicine in Martin, Comenius University, Slovakia

  STUDY DIRECTOR

Central Study Contacts

Peter Liptak, MD, PHD

CONTACT

+421904820189; peter.liptak@gmail.com

Adam Lukac, MD

CONTACT

adamlukac99@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, neither participants nor investigators can be blinded. Participants are aware whether they perform active voluntary sphincter contractions during stimulation, and investigators are involved in patient training and outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist and clinical researcher

Model Details: Participants will be randomized in a 1:1 ratio to receive either home-based anal electrical stimulation combined with active voluntary anal sphincter contraction or electrical stimulation alone. Both interventions will be performed for 12 weeks using identical stimulation parameters.

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary study results and ending 5 years after publication
• Access Criteria: Access will be provided to qualified researchers whose proposed use of the data has been approved by the study investigators and relevant institutional authorities. A data access agreement may be required.

Locations

SL (1)