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Behavioural Intervention

Resistance Device for Bowel Incontinence

N/A

Waitlist Available

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy volunteers without past or present history of fecal incontinence

Be older than 18 years old

Must not have

Neurological disorders like dementia, cerebrovascular diseases

Muscle diseases like muscular dystrophy, myopathies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 6 weeks' exercise, during kegel like exercise

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how different muscles involved in controlling bowel movements get tired and if exercising them against resistance can make them stronger, leading to better control over bowel movements.

Who is the study for?

This trial is for adults over 18 with weak anal sphincters but no history of fecal incontinence. It's not for those with neurological disorders, muscle diseases, inflammatory bowel conditions, complete normal pressure in anal muscles, total loss of rectal sensation or contraction ability, under 18s, certain hip conditions or severe defecation issues.

What is being tested?

The study tests a resistance device designed to strengthen continence muscles. The hypothesis is that resisted contractions will combat fatigue in these muscles and improve control over bowel movements in individuals with weakened anal sphincters.

What are the potential side effects?

Since the intervention involves physical exercise using a resistance device for continence muscles, potential side effects may include muscle soreness or strain similar to what might be experienced after starting any new workout regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had issues controlling my bowel movements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have dementia or diseases related to brain blood vessels.

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I have a muscle disease such as muscular dystrophy.

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I have inflammatory bowel disease or celiac disease.

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I do not have any neuro-muscular junction disorders.

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I am under 18 years old.

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I have a significant pelvic organ prolapse or rectal issue.

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I have hip dysplasia, recent hip surgery, or I cannot move much.

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I have difficulty emptying my bowels due to muscle coordination problems.

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My fecal incontinence is solely because I can't feel my rectum.

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I cannot tighten the muscles around my anus at all.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after 6 weeks' exercise

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after 6 weeks' exercise

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after 6 weeks' exercise for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fecal Incontinence severity

Quality of life measure

Vaginal pressure

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: fatigability of various striated continence muscles healthy adultsActive Control1 Intervention

Device: anorectal manometry/vaginal manometry (female) with and without applying c-RED Participants will do repetitive anal contraction and sustained contraction without device and with device in a random order. For contraction with the device, three different resistance level will be applied as described previously. For isometric contraction, the annal balloon of the device will be inflated to internal pressure of 500mmHg, which is noncompressible. Participants will repeat the repetitive contraction and sustained contraction.

Group II: contribution of continence muscles motor function enhancement in improving fecal incontinenceActive Control1 Intervention

Device: anorectal manometry/vaginal manometry (female) with c-RED Patients will then be assigned to one of the exercise protocols for 6 weeks. Protocol 1: 20 Kegel like repetitive short contractions against a progressively increased intra-vaginal resistance Protocol 2: 40 Kegel like repetitive short contractions against a progressively increased intra-vaginal resistance Protocol 3: 20 Kegel like repetitive short contractions against a progressively increased intra-anal resistance Protocol 4: 40 Kegel like repetitive short contractions against a progressively increased intra-anal resistance Protocol 5: 20 Kegel like repetitive short contractions without device Protocol 6: 40 Kegel like repetitive short contractions without device Protocol 7: 20 Kegel like repetitive short contractions against the non-compressible balloon as previously mentioned Protocol 8:40 Kegel like repetitive short contractions against the non-compressible balloon as previously mentioned

0 / 11Eligibility criteria met