Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00729144
First received: August 5, 2008
Last updated: January 9, 2011
Last verified: October 2010
  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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Adaptation Index and domains [ Time Frame: baseline, 2 wk, 3 mo, 12 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

women with a primary complaint of FI (with or without UI or POP) who are seeking treatment

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729144

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
Sponsors and Collaborators
Investigators
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 April 15, 2014