Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial (ABBI)

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence

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.

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • The University of Alabama at Birmingham
  • California
    • La Jolla, California, United States, 92037
      • University of California, San Diego Medical Center
    • San Diego, California, United States, 92120
      • Kaiser Permanente
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adaptation Index and domains	baseline, 2 wk, 3 mo, 12 mo

Secondary Outcome Measures

Outcome Measure	Time Frame
Fecal Incontinence Severity Index (FISI)	baseline, 2 wk, 3 mo, 12 mo
Medical Outcome Study Short-Form (SF-12)	baseline, 3 mo, 12 mo
Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ)	baseline, 3 mo, 12 mo
Modified Manchester Health Questionnaire	baseline, 3 mo, 12 mo
Patient Global Impression of Improvement (PGI-I)	3 mo, 12 mo

Collaborators and Investigators

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Office of Research on Women's Health (ORWH)
• 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

Publications and helpful links

General Publications

• 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.
• Jelovsek JE, Chen Z, Markland AD, Brubaker L, Dyer KY, Meikle S, Rahn DD, Siddiqui NY, Tuteja A, Barber MD. Minimum important differences for scales assessing symptom severity and quality of life in patients with fecal incontinence. Female Pelvic Med Reconstr Surg. 2014 Nov-Dec;20(6):342-8. doi: 10.1097/SPV.0000000000000078.

Helpful Links

• Pelvic Floor Disorders Network

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: August 5, 2008
• First Submitted That Met QC Criteria: August 5, 2008
• First Posted (Estimate): August 7, 2008

Study Record Updates

• Last Update Posted (Estimate): January 11, 2011
• Last Update Submitted That Met QC Criteria: January 9, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: fecal incontinence; bowel incontinence; pelvic floor disorder
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 1J06-FI; U01HD041249 (U.S. NIH Grant/Contract); U10HD041250 (U.S. NIH Grant/Contract); U10HD041261 (U.S. NIH Grant/Contract); U10HD041267 (U.S. NIH Grant/Contract); U10HD054215 (U.S. NIH Grant/Contract); U10HD054214 (U.S. NIH Grant/Contract); U10HD054136 (U.S. NIH Grant/Contract); U10HD054241 (U.S. NIH Grant/Contract)