Improving continence muscle control and strength.
Mechanisms of Improving Fecal Continence Muscles Motor Function in Health and Disease
This study will try a small resistance balloon device to strengthen the anal and pelvic floor muscles in adults with weak anal sphincters or healthy volunteers to see if muscle contractility improves and fecal leakage decreases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT06532123 on ClinicalTrials.gov |
What this trial studies
Researchers will use a novel continence muscle resistance device (c-RED), combined with state-of-the-art recording modalities, to apply controlled resistance and induce fatigue in the anal sphincter complex and puborectalis muscle. They will characterize fatigue responses using repetitive isotonic contractions with varying loads, intervals, and repetitions recorded intra-anally and intra-vaginally. Participants will perform a 6-week daily fatigue protocol to determine effects on muscle motor function, incontinence severity, and patient-reported quality of life. The protocol will examine differences across the adult age spectrum and between sexes.
Who should consider this trial
Good fit: Adults aged 18 or older with fecal incontinence and measurable reduced anal resting or squeeze pressures who can voluntarily contract their external anal sphincter are ideal candidates.
Not a fit: Patients whose incontinence is entirely due to loss of rectal sensation, those with neuromuscular or primary muscle diseases, complete inability to contract the sphincter, large pelvic organ prolapse or rectocele, or other listed exclusions are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could strengthen continence muscles, reduce fecal incontinence episodes, and improve quality of life.
How similar studies have performed: Conventional pelvic floor muscle training has demonstrated benefit for fecal incontinence, but using controlled resistance-induced fatigue with the c-RED balloon device is a novel approach that has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.