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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Collaborators: |
Office of Research on Women's Health (ORWH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00729144 |
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 |
| 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:
Exclusion Criteria:
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
| 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 |
|
fecal incontinence bowel incontinence pelvic floor disorder |
|
Fecal Incontinence Urinary Incontinence Rectal Diseases Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms |