Biofeedback for Fecal Incontinence

Not Applicable

Completed

• Conditions: Fecal Incontinence

• Registration Number: NCT00124904
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

Fecal incontinence affects 2% of adults in the United States. Biofeedback has been recommended for the treatment of fecal incontinence because uncontrolled studies over the past 25 years suggest that these treatments are as effective as medical or surgical management and involve no risk. However, placebo-controlled trials are still lacking.

The aims of this study are: (1) to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit; (2) to identify which patients are most likely to benefit; and (3) to assess the impact of treatment on quality of life.

Detailed Description

Study I is a long-term, prospective, single-blind study comparing biofeedback for fecal incontinence to a standard therapy (Kegel exercises) that is associated with a similar expectation of improvement (i.e., comparable placebo effect). Prior to randomization, patients will receive medical therapy (antidiarrheal medications as appropriate) and education for 4 weeks, and only patients who remain incontinent will be randomized. Anal canal squeeze pressures and rectal sensory thresholds will be tested before and after treatment. Patients will keep a diary throughout baseline and treatment, and they will be re-assessed at 3, 6, and 12 months. Treatment will consist of 6 clinic visits at 2-week intervals. The primary outcome is the patient's response to the question, "Have you had satisfactory relief of fecal incontinence (yes/no)?" This question is asked at 3 months following the end of treatment and at each follow-up visit. The investigators will develop a detailed treatment manual for fecal incontinence which would permit other investigators to replicate our study.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 2005-07-27
• Study First Submitted QC: 2005-07-27
• Study First Posted: 2005-07-28
• Study Completion: 2006-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Males or females age 16 or above who have an average of one or more episodes of fecal incontinence per week

Exclusion Criteria

• Previous biofeedback treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of subjects reporting adequate relief per treatment group

Secondary Outcome Measures

Name	Time	Method
Demonstrate association of improvement in quality of life with treatment outcome
Identify predictors of successful treatment outcome

Trial Locations

Locations (1)

University of North Carolina Department of Medicine; 🇺🇸 Chapel Hill, North Carolina, United States