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

August 5, 2008
January 9, 2011
June 2008
July 2010   (final data collection date for primary outcome measure)
Adaptation Index and domains [ Time Frame: baseline, 2 wk, 3 mo, 12 mo ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00729144 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial
Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Fecal Incontinence
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Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00729144
1J06-FI, U01HD041249, U10HD041250, U10HD041261, U10HD041267, U10HD054136, U10HD054214, U10HD054215, U10HD054241
Yes
Susan Meikle, MD, NICHD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Office of Research on Women's Health (ORWH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Chair: Holly E Richter, PhD, MD The University of Alabama at Birmingham
Study Chair: Alayne Markland, MD The University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP