Actively Recruiting
Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence
Led by University Hospital, Martin · Updated on 2026-05-28
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Martin
Lead Sponsor
C
Comenius University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate treatments for adults with fecal incontinence, a condition that significantly affects quality of life. The trial compares whether home-based anal electrical stimulation combined with active voluntary anal sphincter contraction is more effective than electrical stimulation alone. It is a prospective, randomized, parallel-group, open-label controlled trial enrolling patients with urge, passive, or mixed fecal incontinence. Participants are randomly assigned to one of two groups. The active group uses a NeuroTrac Continence device to deliver electrical stimulation while performing synchronized voluntary anal sphincter contractions during stimulation cycles. The control group receives the same electrical stimulation but remains relaxed without active contractions. Both groups receive standardized education and device training for a 12-week intervention period. Participants will be assessed at the start, after 12 weeks of treatment, and again at 36 weeks for follow-up. Evaluations include the Vaizey/St. Mark's Incontinence Score, quality of life scales, a 14-day bowel diary, anorectal manometry, adherence tracking, and safety monitoring. Optional ultrasound may be performed if clinically indicated. The main measure is change in incontinence score at 12 weeks, with additional outcomes such as episode frequency, manometry parameters, treatment adherence, adverse events, and sustained response over time.
CONDITIONS
Brief Title
Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older
- 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 or more
- Vaizey (St. Mark's) Incontinence Score of 8 or higher
- 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 will not qualify if you...
- 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 (more than 5 liquid stools per day)
- Anal stenosis preventing probe insertion
- Severe anal sphincter defect (more than 120 degrees on ultrasound) requiring surgical repair
- Isolated severe rectal sensory dysfunction without significant sphincter dysfunction
- Previous pelvic radiotherapy
- Concurrent participation in another interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants use home-based anal electrical stimulation with or without active voluntary anal sphincter contraction for 12 weeks, following device training and standardized patient education.
Baseline visit and regular interim phone or online follow-ups for adherence and safety
Duration - 24 weeks (up to week 36)
Participants are monitored for sustained clinical improvement and adverse events after treatment ends.
1 visit at week 36
Trial Site Locations
Total: 1 location
1
Clinic of Internal Medicine- Gastroenterology, University Hospital Martin
Martin, Slovakia, 03601
Actively Recruiting
Research Team
P
Peter Liptak, MD, PHD
A
Adam Lukac, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here