Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial

NCT00729144 | Completed DMC

• 9 other identifiers: 1J06-FIU01HD041249U10HD041250U10HD041261U10HD041267U10HD054136U10HD054214U10HD054215U10HD054241
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Fecal Incontinence

Keywords

fecal incontinence; bowel incontinence; pelvic floor disorder

Outcome Measures

Primary Outcomes (1)

• Adaptation Index and domains

  baseline, 2 wk, 3 mo, 12 mo

Secondary Outcomes (5)

• 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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (8)

The University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

University of California, San Diego Medical Center

La Jolla, California, 92037, United States

Location

Kaiser Permanente

San Diego, California, 92120, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (2)

• 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.

  PMID: 25185630 DERIVED

• 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.

  PMID: 21344495 DERIVED

MeSH Terms

Conditions

Fecal Incontinence; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Holly E Richter, PhD, MD

  The University of Alabama at Birmingham

  STUDY CHAIR

• Alayne Markland, MD

  The University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 7, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 11, 2011

Record last verified: 2010-10

Locations

US (8)