RecruitingNot ApplicableNCT06532123

Mechanisms of Improving Fecal Continence Muscles Motor Function

Mechanisms of Improving Fecal Continence Muscles Motor Function in Health and Disease

Sponsor

Medical College of Wisconsin

Enrollment

340 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

Fecal Incontinence

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria11

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

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Interventions

DEVICEcontinence muscles resistance device

The c-RED consists of a noncompliant cylindrical balloon (intra-anal balloon) that is connected to a small compliant balloon (external balloon) by a 2 mm diameter tube and a stopcock to allow for air to be filled and sealed in the system. The system is prefilled with air to determine the amount of air needed for a given internal pressure, or desired resistance of the intra-anal balloon. This is determined using a sphygmomanometer gauge in a sealed system.