Improving continence muscle control and strength.
Official title: Mechanisms of Improving Fecal Continence Muscles Motor Function in Health and Disease
Run by Medical College of Wisconsin · NCT06532123 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 340 (estimated) |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Status | Recruiting |
| Started | July 15, 2025 |
| Main results expected | March 1, 2030 |
| Study ends | March 1, 2030 |
| Registry record updated | October 23, 2025 |
| Trial ID | NCT06532123 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Medical College of Wisconsin
Milwaukee, Wisconsin, United States Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Active vs. Passive Anal Sphincter Training in Fecal Incontinence
This home-based trial tests whether adding active sphincter contractions to electrical stimulation helps adults with fecal incontinence more than stimulation alone.
-
Beta-glucan cream added to standard skin care for IAD in hospitalized adults
This study tests whether adding a 0.5% beta-glucan moisturizing cream to usual skin care helps adults with incontinence-associated dermatitis heal faster and feel better.
-
R20 Sacral Neuromodulation for Fecal Incontinence: Post‑Market Follow‑Up
This registry test checks how well the Axonics R20 rechargeable device works for adults with fecal incontinence after it’s on the market.
-
High-intensity electromagnetic stimulation for bowel control after J-pouch surgery
Aims to see if the Emsella chair can help people with a J pouch who have fecal incontinence after ulcerative colitis surgery.
-
Intra-rectal Botulinum Toxin Injection for Children with Non-Retentive Fecal Incontinence
This trial tests whether injecting botulinum toxin into the rectum can help children who have frequent non-retentive fecal incontinence that isn’t caused by constipation.
-
Investigating the effects of sacral neuromodulation on fecal incontinence and the external anal sphincter
This study is trying to see how a treatment called sacral neuromodulation can help people with fecal incontinence by looking at changes in the muscles around the anus.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.