Mechanisms of Improving Fecal Continence Muscles Motor Function
ConditionFecal Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
continence muscles resistance device
DeviceThe 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.
Treatment groups
340 Participants
are divided into 2 treatment groupsGroup A: fatigability of various striated continence muscles healthy adultsActive comparator 1 intervention
Group B: contribution of continence muscles motor function enhancement in improving fecal incontinenceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
anal pressure
Maximum squeeze pressure, mean squeeze pressure and anal squeeze contractile integral
Time frame
during kegel like exercise2
anal pressure
Maximum squeeze pressure, mean squeeze pressure and anal squeeze contractile integral
Time frame
after 6 weeks' exercise, during kegel like exercise3
Vaginal pressure
Maximum squeeze pressure, mean squeeze pressure and vaginal squeeze contractile integral
Time frame
during kegel like exercise4
Vaginal pressure
Maximum squeeze pressure, mean squeeze pressure and vaginal squeeze contractile integral
Time frame
after 6 weeks' exercise, during kegel like exerciseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov