Fecal IncontinenceACTIPASTNCT07604415
Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence
A study testing Home-based anal electrical stimulator in people with Fecal Incontinence, run by University Hospital, Martin at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Home-based anal electrical stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSlovakia
- Study dates
- 15 May 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Adam Lukac, MD contact
Slovakia1 site, 1 recruiting
- Recruiting
Clinic of Internal Medicine- Gastroenterology, University Hospital Martin
Martin, 03601
Peter Liptak, MD, PhD, +421904820189, peter.liptak@gmail.com
Adam Lukac, MD, adamlukac99@gmail.com
About this study
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.
Read the 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.
- Conditions
- Fecal Incontinence
- Being tested
- Home-based anal electrical stimulator
- Keywords
- fecal incontinence, anal stimulation, pelvic floor training
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based anal electrical stimulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation + Active Contraction | Active comparator | Home-based anal electrical stimulation combined with synchronized active voluntary anal sphincter contraction for 12 weeks Receives: Device: Home-based anal electrical stimulator |
| Electrical Stimulation Alone | Active comparator | Home-based anal electrical stimulation alone without active voluntary sphincter contraction for 12 weeks. Receives: Device: Home-based anal electrical stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline to Week 12
Change in Squeeze Endurance on High-Resolution Anorectal Manometry
Mean change in squeeze endurance measured during HRAM assessment.
Measured: Baseline to Week 12
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.
Measured: Baseline to Week 12
Treatment Adherence Rate
Percentage of prescribed home stimulation sessions completed during the 12-week intervention period
Measured: 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.
Measured: Baseline to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 May 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either home-based anal electrical stimulation combined with active voluntary anal sphincter contraction or electrical stimulation alone. Both interventions will be performed for 12 weeks using identical stimulation parameters.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Collaborators
- Comenius University
- Responsible party
- Principal investigator, Peter Liptak, University Hospital, Martin
- Investigators
- Peter Liptak, MD, PhD, Study director, Clinic of Internal Medicine- Gastroenterology, University Hospital Martin, Jessenous Faculty of Medicine in Martin, Comenius University, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604415
- Sponsor's protocol ID
- EK38/2026
- Acronym
- ACTIPAST
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence
- ClinicalTrials.gov ID
- NCT07604415
- Acronym / sponsor ID
- ACTIPAST / EK38/2026
- Conditions
- Fecal Incontinence
- Keywords
- fecal incontinence, anal stimulation, pelvic floor training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, MartinUniversity, hospital or other
- Collaborators
- Comenius University
- Study start
- 15 May 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either home-based anal electrical stimulation combined with active voluntary anal sphincter contraction or electrical stimulation alone. Both interventions will be performed for 12 weeks using identical stimulation parameters.
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation + Active Contraction | Active comparator | Device: Home-based anal electrical stimulatorHome-based anal electrical stimulation combined with synchronized active voluntary anal sphincter contraction for 12 weeks |
| Electrical Stimulation Alone | Active comparator | Device: Home-based anal electrical stimulatorHome-based anal electrical stimulation alone without active voluntary sphincter contraction for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based anal electrical stimulatorHome-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. | Device | Electrical Stimulation + Active Contraction, Electrical Stimulation Alone |
Primary outcome
Change in Vaizey (St. Mark's) Incontinence Score From Baseline to Week 12
Time frame: 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.
9 secondary outcomes
Change in Weekly Fecal Incontinence Episodes From Baseline to Week 12
Time frame: Baseline to Week 12
Proportion of Participants Achieving ≥30% Reduction in Vaizey Score at Week 12
Time frame: Week 12
Sustained Improvement in Vaizey Score at Week 36
Time frame: Baseline to Week 36
Change in Maximum Squeeze Pressure on High-Resolution Anorectal Manometry
Time frame: Baseline to Week 12
Change in Resting Anal Pressure on High-Resolution Anorectal Manometry
Time frame: Baseline to Week 12
Change in Squeeze Endurance on High-Resolution Anorectal Manometry
Time frame: Baseline to Week 12
Change in Fecal Incontinence Quality of Life (FIQL) Scores
Time frame: Baseline to Week 12
Treatment Adherence Rate
Time frame: During the 12-week intervention period
Incidence of Adverse Events and Device-Related Complications
Time frame: Baseline to Week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Lukac, MD contact
Peter Liptak, MD, PhD study director
Clinic of Internal Medicine- Gastroenterology, University Hospital Martin, Jessenous Faculty of Medicine in Martin, Comenius University, Slovakia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based anal electrical stimulator in people with Fecal Incontinence, run by University Hospital, Martin at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Liptak, MD, PHD (+421904820189, peter.liptak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vaizey (St. Mark's) Incontinence Score From Baseline to Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.