Active vs. Passive Anal Sphincter Training in Fecal Incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, randomized, parallel-group, open-label study compares two home-based rehabilitation approaches for fecal incontinence. Participants are adults with urge, passive, or mixed fecal incontinence and are randomized 1:1 to either electrical stimulation with synchronized active sphincter contraction or electrical stimulation alone for 12 weeks. Primary outcome is change in Vaizey/St. Mark's Incontinence Score from baseline to week 12, with secondary outcomes including incontinence episodes, quality of life, anorectal manometry, adherence, safety, and sustained response during follow-up. The study will be conducted at University Hospital Martin in Slovakia, with potential inclusion of another center, and uses a NeuroTrac Continence device with standardized stimulation parameters. All participants receive education and device training as part of the intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Clinic of Internal Medicine- Gastroenterology, University Hospital Martin
  Martin, Slovakia Recruiting

Study contacts

• Study coordinator: Peter Liptak, MD, PHD
• Email: peter.liptak@gmail.com
• Phone: +421904820189

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.