RecruitingNot Applicable

Mechanisms of Improving Fecal Continence Muscles Motor Function

United States340 participantsStarted 2025-07-15

Plain-language summary

The investigators hypothesize that different continence muscles have different fatigue characteristics and fatigue induced by resisted contractions will result in significant increase in contractility of the continence muscles and improvement of fecal incontinence severity.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy volunteers without past or present history of fecal incontinence * Patients age 18 years and older with reduced anal resting and or squeeze pressure, reflecting weakness of the anal sphincters who can perform the study Exclusion Criteria: * Any one less than 18 years old * Neurological disorders like dementia, cerebrovascular diseases * Muscle diseases like muscular dystrophy, myopathies * Inflammatory bowel disease or celiac disease * Neuro-muscular junction disorders/myasthenia gravis, Eaton-Lambert syndrome * Organ prolapse, large rectocele(\>2cm), rectal intussusception * Hip dysplasia or recent hip surgery and immobile patients. * Patients with complete normal anal resting and squeeze pressure * Impaired rectal evacuation (dyssynergy defecation) * Fecal incontinence completely due to loss of rectal sensation * Subjects unable to contract their external anal sphincter at all

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

anal pressure

Timeframe: during kegel like exercise

anal pressure

Timeframe: after 6 weeks' exercise, during kegel like exercise

Vaginal pressure

Timeframe: during kegel like exercise

Vaginal pressure

Timeframe: after 6 weeks' exercise, during kegel like exercise

Fecal Incontinence severity

Timeframe: before and after 6 weeks' exercise

Quality of life measure

Timeframe: before and after 6 weeks' exercise

Trial details

NCT IDNCT06532123

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-03-01

View on ClinicalTrials.gov More Fecal Incontinence trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

anal pressure

Timeframe: during kegel like exercise

anal pressure

Timeframe: after 6 weeks' exercise, during kegel like exercise

Vaginal pressure

Timeframe: during kegel like exercise

Vaginal pressure

Timeframe: after 6 weeks' exercise, during kegel like exercise

Fecal Incontinence severity

Timeframe: before and after 6 weeks' exercise

Quality of life measure

Timeframe: before and after 6 weeks' exercise