Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial
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Purpose
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.
| Condition |
|---|
|
Fecal Incontinence |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial |
- Adaptation Index and domains [ Time Frame: baseline, 2 wk, 3 mo, 12 mo ] [ Designated as safety issue: No ]
- Fecal Incontinence Severity Index (FISI) [ Time Frame: baseline, 2 wk, 3 mo, 12 mo ] [ Designated as safety issue: No ]
- Medical Outcome Study Short-Form (SF-12) [ Time Frame: baseline, 3 mo, 12 mo ] [ Designated as safety issue: No ]
- Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) [ Time Frame: baseline, 3 mo, 12 mo ] [ Designated as safety issue: No ]
- Modified Manchester Health Questionnaire [ Time Frame: baseline, 3 mo, 12 mo ] [ Designated as safety issue: No ]
- Patient Global Impression of Improvement (PGI-I) [ Time Frame: 3 mo, 12 mo ] [ Designated as safety issue: No ]
| Enrollment: | 133 |
| Study Start Date: | June 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
women with a primary complaint of FI (with or without UI or POP) who are seeking treatment
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| United States, Alabama | |
| The University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35249 | |
| United States, California | |
| University of California, San Diego Medical Center | |
| La Jolla, California, United States, 92037 | |
| Kaiser Permanente | |
| San Diego, California, United States, 92120 | |
| United States, Illinois | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| University of Texas Southwestern | |
| Dallas, Texas, United States, 75390 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| Study Chair: | Holly E Richter, PhD, MD | The University of Alabama at Birmingham |
| Study Chair: | Alayne Markland, MD | The University of Alabama at Birmingham |
More Information
Additional Information:
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Susan Meikle, MD, NICHD |
| ClinicalTrials.gov Identifier: | NCT00729144 History of Changes |
| Other Study ID Numbers: | 1J06-FI, U01HD041249, U10HD041250, U10HD041261, U10HD041267, U10HD054136, U10HD054214, U10HD054215, U10HD054241 |
| Study First Received: | August 5, 2008 |
| Last Updated: | January 9, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
fecal incontinence bowel incontinence pelvic floor disorder |
Additional relevant MeSH terms:
|
Fecal Incontinence Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013