Fecal Incontinence Clinical Trial
Official title:
An Innovative Rehabilitation Approach for Women With Anal Incontinence
NCT number | NCT03252951 |
Other study ID # | 141728 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2017 |
Est. completion date | June 30, 2022 |
Verified date | October 2022 |
Source | San Diego State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 pelvic floor muscle strengthening, but this strategy does not incorporate strategies for resistance training that are known to cause muscle strengthening and hypertrophy in other muscles in the body. This study aims to investigate whether a novel pelvic floor resistance exercise program will increase pelvic floor muscle strength and improve anal incontinence and has the potential to impact rehabilitation strategies for the millions of women affected anal incontinence.
Status | Completed |
Enrollment | 71 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: - AI based on FISI questionnaire - FISI scores between 10 and 45 - able to voluntarily contract pelvic floor muscles based on manometry measures Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
San Diego State University | University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Length Tension Manometry after 1 year | change from baseline to 12 months | 12 months | |
Other | Change in Length Tension Manometry after 2 years | change from baseline to 24 months | 24 months | |
Other | Change in Muscle Hypertrophy (ultrasound) after 1 year | change from baseline to 12 months | 12 months | |
Other | Change in Muscle Hypertrophy (ultrasound) after 2 years | change from baseline to 24 months | 24 months | |
Other | Change in FISI score after 1 year | change from baseline to 12 months | 12 months | |
Other | Change in FISI score after 2 years | change from baseline to 24 months | 24 months | |
Primary | Change in Length Tension Manometry after 12 weeks | change from baseline to 12 weeks | 12 weeks | |
Secondary | Change in Muscle Hypertrophy (Ultrasound) after 12 weeks | change from baseline to 12 weeks | 12 weeks | |
Secondary | Change in FISI score after 12 weeks | change from baseline to 12 weeks | 12 weeks |
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