Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial
- Conditions
- Fecal Incontinence
- Registration Number
- NCT00729144
- Lead Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- 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 with FI.
- 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 for others, knowledge of restroom locations. Little is known about the role of such behaviors in helping women adapt to urinary incontinence (UI), pelvic organ prolapse (POP), or fecal incontinence (FI). Additionally, there are no studies that address the persistence of these behaviors following treatment as measured by traditional outcomes. Results of a pilot study that assessed quality of life (QOL) in women with pelvic floor disorders (PFD) indicated that women relied heavily on behavioral adaptation in order to cope with PFD symptoms. Subsequently, a draft Adaptation Index was developed with input from investigators of the Pelvic Floor Disorders Network (PFDN). This measure was further refined by focus groups as part of the 1J06 protocol. The 1J06 study is investigating the properties of this tool in subjects with UI and POP. This study focuses on the validation of this instrument as a measurement of adaptive behaviors used to reduce symptoms of FI and to describe the use of adaptive behaviors among women with FI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 133
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adaptation Index and domains baseline, 2 wk, 3 mo, 12 mo
- Secondary Outcome Measures
Name Time Method Fecal Incontinence Severity Index (FISI) baseline, 2 wk, 3 mo, 12 mo Medical Outcome Study Short-Form (SF-12) baseline, 3 mo, 12 mo Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) baseline, 3 mo, 12 mo Modified Manchester Health Questionnaire baseline, 3 mo, 12 mo Patient Global Impression of Improvement (PGI-I) 3 mo, 12 mo
Trial Locations
- Locations (8)
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
University of California, San Diego Medical Center
🇺🇸La Jolla, California, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
Duke University
🇺🇸Durham, North Carolina, United States