Status:
COMPLETED
Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
Office of Research on Women's Health (ORWH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Fecal Incontinence
Eligibility:
FEMALE
Brief Summary
This study focuses on the validation of the Adaptation Index instrument as a measurement of adaptive behaviors used to reduce symptoms of FI and to describe the use of adaptive behaviors among women w...
Detailed Description
It is common knowledge that women with pelvic floor dysfunction will develop, initiate and adopt behaviors which mitigate their symptoms or impairment. For some women, this involves wearing a pad and ...
Eligibility Criteria
Inclusion
- Primary complaint of FI with liquid, solid stool, or mucous incontinence, occurring at least monthly for 3 consecutive months. These women are planning to have treatment for FI.
- Women with prior treatment, including surgery for their FI, UI, and/or POP may be included if they now have a primary complaint of FI as defined above and are planning to have additional or new treatment for FI.
Exclusion
- Diagnosis of interstitial cystitis, , bladder or colo-rectal malignancy or inflammatory bowel disease
- Refusal or inability to provide written consent
- Inability to complete telephone interviews conducted in English or Spanish
- Prior pelvic irradiation
- Incontinence only to flatus
- Prior removal of any portion of the colon or rectum
- Current or history of rectovaginal fistula(e)
- Rectal prolapse
- Neurologic disorders known to affect continence, including Multiple Sclerosis, Spinal Cord Injury, Debilitating Stroke, and Parkinson's Disease
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00729144
Start Date
June 1 2008
End Date
July 1 2010
Last Update
January 11 2011
Active Locations (8)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
University of California, San Diego Medical Center
La Jolla, California, United States, 92037
3
Kaiser Permanente
San Diego, California, United States, 92120
4
Loyola University Medical Center
Maywood, Illinois, United States, 60153