Biofeedback for Dyssynergic Constipation - Full Text View

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:	NCT00127257

Purpose

Constipation affects 4% of adults in the United States (U.S.). An estimated half of constipated patients are unable to relax pelvic floor muscles during defecation, a type of constipation called pelvic floor dyssynergia (PFD). Biofeedback has been recommended for the treatment of constipation because uncontrolled studies over the past 10 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:

to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit;
to identify which patients are most likely to benefit; and
to assess the impact of treatment on quality of life.

Condition	Intervention
Constipation	Behavioral: Biofeedback Drug: Diazepam Behavioral: Pelvic floor retraining

MedlinePlus related topics: Constipation Pelvic Support Problems

Drug Information available for: Diazepam

U.S. FDA Resources

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

Primary Outcome Measures:

Proportion of subjects reporting adequate relief per treatment group

Secondary Outcome Measures:

Demonstrate association of improvement in quality of life with treatment outcome
Identify predictors of successful treatment outcome
Describe physiological mechanism of treatment effects

Estimated Enrollment:	117
Study Start Date:	September 1999
Estimated Study Completion Date:	June 2006

Detailed Description:

This study is a long-term prospective, single-blind study comparing biofeedback for pelvic floor dyssynergia to a skeletal muscle relaxant drug (diazepam 5 mg two hours before attempted defecation) and to placebo medication. Prior to randomization, patients will first receive medical therapy (laxatives and education) for 4 weeks and only those remaining constipated will be randomized. Physiological tests of anal canal pressure during straining to defecate and ability to pass a 50-ml air filled balloon will be tested before and after treatment. Patients will keep a diary throughout baseline and treatment, and they will be reassessed at 3, 6, and 12 months follow-up. Treatment will consist of 6 clinic visits at 2-week intervals. The investigators will develop a detailed treatment manual for this disorder which would permit other investigators to replicate their study.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females ages 16 or above who have symptoms of constipation due to pelvic floor dyssynergia

Exclusion Criteria:

Pregnancy (because of the possibility of randomization into the diazepam group)
Prior history of biofeedback treatment for pelvic floor disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127257

Locations

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)

Investigators

Principal Investigator:

William E Whitehead, PhD

The University of North Carolina, Chapel Hill

More Information

Publications of Results:

Heymen S, Scarlett Y, Whitehead WE. Constipated subjects reporting physical abuse are more likely to fail an education/medical management intervention. Am J Gastroenterol Suppl 2004;99:T1364

Heymen S, Scarlett Y, Whitehead WE. Severity of constipation and anxiety predict failure to improve with conservative medical treatment for constipation. Am J Gastroenterol Suppl 2004;99:T1370

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.

Other 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, Jones KR, Scarlett Y, Whitehead WE. Biofeedback treatment of constipation: a critical review. Dis Colon Rectum. 2003 Sep;46(9):1208-17. Review.

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.

Study ID Numbers:	RO1 DK57048b
Study First Received:	August 4, 2005
Last Updated:	August 24, 2007
ClinicalTrials.gov Identifier:	NCT00127257
Health Authority:	United States: Federal Government

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

Constipation
Biofeedback
Dyssynergia
Pelvic floor dyssynergia
Outlet dysfunction

Study placed in the following topic categories:

Signs and Symptoms
Fecal Incontinence
Signs and Symptoms, Digestive

Diazepam
Constipation
Urinary Incontinence

ClinicalTrials.gov processed this record on January 16, 2009