Status:
COMPLETED
Physical Therapy for Anal Incontinence
Lead Sponsor:
San Diego State University
Collaborating Sponsors:
University of California, San Diego
Conditions:
Anal Incontinence
Fecal Incontinence
Eligibility:
FEMALE
22+ years
Phase:
NA
Brief Summary
Anal incontinence is a significant public health problem estimated to affect 7-15% of women in the United States. Traditional rehabilitation strategies include biofeedback and Kegel exercises for pelv...
Detailed Description
The current proposal is focused on examining whether a novel resistance exercise program for the pelvic floor will strengthen pelvic floor muscles and improve symptoms in women with anal incontinence....
Eligibility Criteria
Inclusion
- AI based on FISI questionnaire
- FISI scores between 10 and 45
- able to voluntarily contract pelvic floor muscles based on manometry measures
Exclusion
- FISI score below 10 (mild disease) or greater than 45 (severe disease)
- manometry measure below the 10th percentile of normal (lack of muscle) or above 70th percentile of normal (little room to improve strength)
- history of large external hemorrhoids or history of bleeding hemorrhoids; co-existing inflammatory bowel disease
- constipation that is directly linked to neurological conditions such as spinal and peripheral nerve pathologies
- large pelvic organ prolapse (greater than stage 3)
- inability to contract the pelvic floor muscles on command
- pregnancy
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT03252951
Start Date
September 1 2017
End Date
June 30 2022
Last Update
October 25 2022
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92102