Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial

Fecal Incontinence Clinical Trial

— ABBI  

Official title:

Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729144
• Other study ID #: 1J06-FI
• Secondary ID: U01HD041249U10HD
• Status: Completed
• Phase: N/A
• First received: August 5, 2008
• Last updated: January 9, 2011
• Start date: June 2008
• Est. completion date: July 2010

Study information

• Verified date: October 2010
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fecal Incontinence

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	University of California, San Diego Medical Center	La Jolla	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Utah	Salt Lake City	Utah
United States	Kaiser Permanente	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Research on Women's Health (ORWH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adaptation Index and domains		baseline, 2 wk, 3 mo, 12 mo	No
Secondary	Fecal Incontinence Severity Index (FISI)		baseline, 2 wk, 3 mo, 12 mo	No
Secondary	Medical Outcome Study Short-Form (SF-12)		baseline, 3 mo, 12 mo	No
Secondary	Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ)		baseline, 3 mo, 12 mo	No
Secondary	Modified Manchester Health Questionnaire		baseline, 3 mo, 12 mo	No
Secondary	Patient Global Impression of Improvement (PGI-I)		3 mo, 12 mo	No

External Links

•   Pelvic Floor Disorders Network