Biofeedback for Fecal Incontinence

This study has been completed.

Sponsor:

Information provided by:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

ClinicalTrials.gov Identifier:

NCT00124904

First received: July 27, 2005

Last updated: January 12, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 27, 2005

Last Updated Date

January 12, 2010

Start Date ^ICMJE

September 1999

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Proportion of subjects reporting adequate relief per treatment group

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00124904 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Demonstrate associate of improvement in quality of life with treatment outcome
Identify predictors of successful treatment outcome

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Biofeedback for Fecal Incontinence

Official Title ^ICMJE

Biofeedback for Fecal Incontinence and Constipation

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Condition ^ICMJE

Fecal Incontinence

Intervention ^ICMJE

Behavioral: Biofeedback
Behavioral: Kegel exercises

Study Arm (s)

Not Provided

Publications *

Heymen S, Scarlett Y, Whitehead WE. Anorectal physiology predicts response to conservative medical management of fecal incontinence. Am J Gastroenterol Suppl 2004;99:M1583.
Heymen S, Scarlett Y, Whitehead WE. Education and medical management resolve fecal incontinence in 35%, but depression and greater symptom severity predict a poor response. Am J Gastroenterol Suppl 2004;99:T1374.
Heymen S, Scarlett Y, and Whitehead WE. Elevated Beck Depression Inventory (BDI) Scores Predict Biofeedback Treatment Failure for Fecal Incontinence and Constipation (abstract). Gastroenterology 2003,124:4(suppl 1)A-685.
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.
Jones KR, Heymen S, Whitehead WE. Biofeedback for Anorectal Disorders. In: Drutz HP, Herschorn S, Diamant NE (Eds), Female Pelvic Medicine and Reconstructive Pelvic Surgery. London, Springer-Verlag, 2003. Pp 313-325.
Whitehead WE, Heymen S, Schuster MM. Motility as a therapeutic modality: biofeedback treatment of gastrointestinal disorders. Chapter 27. In MM Schuster, MD Crowell, KL Koch (Eds.), Schuster Atlas of Gastrointestinal Motility in Health and Disease. London, BC Decker Inc. 2002; 381-397.
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.
Heymen S, Jones KR, Ringel Y, Scarlett Y, Drossman D, Whitehead WE (abstract). Biofeedback for fecal incontinence and constipation: the role of medical management and education. Gastro 2001 (suppl 1):120, A397.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

165

Completion Date

December 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00124904

Other Study ID Numbers ^ICMJE

RO1 DK57048a (completed)

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

William E Whitehead, PhD

University of North Carolina, Chapel Hill

Information Provided By

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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