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Biofeedback for Fecal Incontinence

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ClinicalTrials.gov Identifier: NCT00124904
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : January 13, 2010
Information provided by:
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.

Condition or disease Intervention/treatment
Fecal Incontinence Behavioral: Biofeedback Behavioral: Kegel exercises

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Biofeedback for Fecal Incontinence and Constipation
Study Start Date : September 1999
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Primary Outcome Measures :
  1. Proportion of subjects reporting adequate relief per treatment group

Secondary Outcome Measures :
  1. Demonstrate association of improvement in quality of life with treatment outcome
  2. Identify predictors of successful treatment outcome

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124904

United States, North Carolina
University of North Carolina Department of Medicine
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: William E Whitehead, PhD University of North Carolina, Chapel Hill

Additional Information:
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.
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, Drossman D, Whitehead WE (abstract). Biofeedback for fecal incontinence and constipation: the role of medical management and education. Gastro 2001 (suppl 1):120, A397.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00124904     History of Changes
Other Study ID Numbers: RO1 DK57048a (completed)
First Posted: July 28, 2005    Key Record Dates
Last Update Posted: January 13, 2010
Last Verified: January 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases