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Completed

NCT Number: NCT00729144

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

The University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Adaptation Index and domains

    Time frame: baseline, 2 wk, 3 mo, 12 mo

Secondary outcomes

  1. Fecal Incontinence Severity Index (FISI)

    Time frame: baseline, 2 wk, 3 mo, 12 mo

  2. Medical Outcome Study Short-Form (SF-12)

    Time frame: baseline, 3 mo, 12 mo

  3. Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ)

    Time frame: baseline, 3 mo, 12 mo

  4. Modified Manchester Health Questionnaire

    Time frame: baseline, 3 mo, 12 mo

  5. Patient Global Impression of Improvement (PGI-I)

    Time frame: 3 mo, 12 mo

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Office of Research on Women's Health (ORWH)

Registry information

Acronym: ABBI

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 7, 2008
Registry last updated
Jan 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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