NCT07604415 Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence
| NCT ID | NCT07604415 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Martin |
| Condition | Fecal Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-05-15 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Peter Liptak, MD, PhD
STUDY DIRECTOR
Clinic of Internal Medicine- Gastroenterology, University Hospital Martin, Jessenous Faculty of Medicine in Martin, Comenius University, Slovakia
Frequently Asked Questions
Who can join the NCT07604415 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fecal Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07604415 currently recruiting?
Yes, NCT07604415 is actively recruiting participants. Contact the research team at peter.liptak@gmail.com for enrollment information.
Where is the NCT07604415 trial being conducted?
This trial is being conducted at Martin, Slovakia.
Who is sponsoring the NCT07604415 clinical trial?
NCT07604415 is sponsored by University Hospital, Martin. The principal investigator is Peter Liptak, MD, PhD at Clinic of Internal Medicine- Gastroenterology, University Hospital Martin, Jessenous Faculty of Medicine in Martin, Comenius University, Slovakia. The trial plans to enroll 24 participants.