Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence (ACTIPAST)

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.

Study Overview

• Status: Recruiting
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Home-based anal electrical stimulator

Detailed Description

This prospective randomized controlled trial will compare two home-based rehabilitation approaches for fecal incontinence. Eligible adult patients with urge, passive, or mixed fecal incontinence will be enrolled at study site: University Hospital Martin, Slovakia. Possibility to incorporate another study centre with be allowed. Participants will be randomized in a 1:1 ratio to one of two treatment arms.

In the active treatment arm, participants will use anal electrical stimulation combined with active voluntary anal sphincter contraction. Electrical stimulation will be delivered using the commercially available NeuroTrac Continence device with a frequency of 40 Hz, pulse width of 250 µs, 5-second ON and 10-second OFF cycles, 1-second ramp-up, and a session duration of 25 minutes. Stimulation intensity will be adjusted by the patient up to the maximum tolerable level without pain. Participants will be instructed to perform a maximum voluntary anal sphincter contraction for 5 seconds at the start of each stimulation ON cycle and to relax during the rest phase.

In the control intervention arm, participants will use identical electrical stimulation parameters but will remain relaxed during stimulation and will not perform active voluntary sphincter contractions. Both groups will receive standardized patient education, including device training and written instructions.

The intervention period will last 12 weeks. Study assessments will include the Vaizey/St. Mark's Incontinence Score, Fecal Incontinence Quality of Life scale, 14-day bowel diary, adherence assessment, adverse event monitoring, and high-resolution anorectal manometry. Optionally patients will be also assessed by endoanal ultrasound to detect possible structural abnormalities where clinical suspicion of these will be present. Assessments will be performed at baseline, week 12, and week 36 (as a post treatment follow up), with interim phone or secure online follow-up for adherence and safety. The primary endpoint is the mean change in Vaizey/St. Mark's Incontinence Score from baseline to week 12. Secondary endpoints include changes in weekly fecal incontinence episodes, FIQL subscales, anorectal manometry parameters, treatment adherence, adverse events, and sustained clinical improvement during follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Liptak, MD, PhD; Phone Number: +421904820189; Email: peter.liptak@gmail.com
• Study Contact Backup: Name: Adam Lukac, MD; Email: adamlukac99@gmail.com

Study Locations

• Slovakia
  • Martin, Slovakia, 03601
    • Recruiting
    • Clinic of Internal Medicine- Gastroenterology, University Hospital Martin
    • Contact: Peter Liptak, MD, PhD; Phone Number: +421904820189; Email: peter.liptak@gmail.com
    • Contact: Adam Lukac, MD; Email: adamlukac99@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Electrical Stimulation + Active Contraction; Home-based anal electrical stimulation combined with synchronized active voluntary anal sphincter contraction for 12 weeks	Device: Home-based anal electrical stimulator; 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.
Active Comparator: Electrical Stimulation Alone; Home-based anal electrical stimulation alone without active voluntary sphincter contraction for 12 weeks.	Device: Home-based anal electrical stimulator; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 12
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.	Week 12
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.	Baseline to Week 36
Change in Maximum Squeeze Pressure on High-Resolution Anorectal Manometry	Mean change in maximum squeeze pressure measured by high-resolution anorectal manometry (HRAM).	Baseline to Week 12
Change in Resting Anal Pressure on High-Resolution Anorectal Manometry	Mean change in resting anal pressure measured by high-resolution anorectal manometry (HRAM).	Baseline to Week 12
Change in Squeeze Endurance on High-Resolution Anorectal Manometry	Mean change in squeeze endurance measured during HRAM assessment.	Baseline to Week 12
Treatment Adherence Rate	Percentage of prescribed home stimulation sessions completed during the 12-week intervention period	During the 12-week intervention period
Incidence of Adverse Events and Device-Related Complications	Number and type of adverse events and device-related complications reported during the study period.	Baseline to Week 36
Change in Fecal Incontinence Quality of Life (FIQL) Scores	Mean change in FIQL subscale scores (Lifestyle, Coping/Behavior, Depression/Self-Perception, and Embarrassment) from baseline. FIQL subscale scores range from 1 to 4, with higher scores indicating better quality of life.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: University Hospital, Martin
• Collaborators: Comenius University
• Investigators: Study Director: Peter Liptak, MD, PhD, Clinic of Internal Medicine- Gastroenterology, University Hospital Martin, Jessenous Faculty of Medicine in Martin, Comenius University, Slovakia

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: May 17, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: fecal incontinence; pelvic floor training; anal stimulation
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: EK38/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the reported study results may be shared upon reasonable request to the principal investigator following publication of the primary results. Data sharing will be considered for methodologically sound research proposals and in accordance with institutional policies, ethical approval requirements, and applicable data protection regulations (including GDPR).
• IPD Sharing Time Frame: Beginning 6 months after publication of the primary study results and ending 5 years after publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No