Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence
ConditionFecal Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Martin
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Home-based anal electrical stimulator
DeviceHome-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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Electrical Stimulation + Active ContractionActive comparator 1 intervention
Group B: Electrical Stimulation AloneActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to Week 12Secondary outcomes
1
Change in Weekly Fecal Incontinence Episodes From Baseline to Week 12
Mean change in the number of weekly fecal incontinence episodes recorded in a 14-day bowel diary.
Time frame
Baseline to Week 122
Proportion of Participants Achieving ≥30% Reduction in Vaizey Score at Week 12
Percentage of participants achieving at least a 30% reduction in Vaizey (St. Mark's) Incontinence Score compared with baseline.
Time frame
Week 123
Sustained Improvement in Vaizey Score at Week 36
Mean change in Vaizey (St. Mark's) Incontinence Score at long-term follow-up compared with baseline.
Time frame
Baseline to Week 364
Change in Maximum Squeeze Pressure on High-Resolution Anorectal Manometry
Mean change in maximum squeeze pressure measured by high-resolution anorectal manometry (HRAM).
Time frame
Baseline to Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Martin
Lead sponsor
Comenius University
Collaborator
Source ClinicalTrials.gov