Clinical Trial: Biofeedback for Fecal Incontinence

This study is currently recruiting patients.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) July 2005

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00124904

Purpose

Fecal incontinence affects 2% of adults in the U.S. 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.
Condition Intervention
Fecal Incontinence
 Behavior: Biofeedback
 Behavior: Kegel exercises

MedlinePlus related topics:  Anal and Rectal Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Biofeedback for Fecal Incontinence and Constipation

Further Study Details: 
Primary Outcomes: Proportion of subjects reporting adequate relief per treatment group
Secondary Outcomes: Demonstrate association of improvement in quality of life with treatment outcome; Identify predictors of successful treatment outcome
Expected Total Enrollment:  165

Study start: September 1999;  Expected completion: June 2007
Last follow-up: December 2006;  Data entry closure: December 2006

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. We will develop a detailed treatment manual for fecal incontinence which would permit other investigators to replicate our study.

Eligibility

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria: Males or females age 16 or above who have an average of one or more episode of fecal incontinence per week

Exclusion Criteria: Previous biofeedback treatment

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00124904

Steve Heymen, MS      919-966-2515    steve_heymen@med.unc.edu

North Carolina
      University of North Carolina Department of Medicine, Chapel Hill,  North Carolina,  27599,  United States; Recruiting
Tony G Waldrop, PhD  919-966-3411    tony_waldrop@unc.edu 
William E Whitehead, PhD,  Principal Investigator
Steve Heymen, MS,  Sub-Investigator
Yolanda Scarlett, MD,  Sub-Investigator
Yehuda Ringel, MD,  Sub-Investigator
Douglas A Drossman, MD,  Sub-Investigator

Study chairs or principal investigators

William E Whitehead, PhD,  Principal Investigator,  University of North Carolina   

More Information

Center website

Publications

Palsson OS, Heymen S, Whitehead WE. Biofeedback treatment for functional anorectal disorders: a comprehensive efficacy review. Appl Psychophysiol Biofeedback. 2004 Sep;29(3):153-74. Review.

Heymen S. Psychological and cognitive variables affecting treatment outcomes for urinary and fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S146-51. Review.

Heymen S, Jones KR, Ringel Y, Scarlett Y, Whitehead WE. Biofeedback treatment of fecal incontinence: a critical review. Dis Colon Rectum. 2001 May;44(5):728-36.

Study ID Numbers:  RO1 DK57048a
Last Updated:  July 29, 2005
Record first received:  July 27, 2005
ClinicalTrials.gov Identifier:  NCT00124904
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-02



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