Biofeedback for Dyssynergic Constipation

Condition(s) targeted: Constipation

Intervention: Biofeedback (Behavioral); Diazepam (Drug); Pelvic floor retraining (Behavioral)

Phase: N/A

Status: Completed

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

Official(s) and/or principal investigator(s):
William E Whitehead, PhD, Principal Investigator, Affiliation: University of North Carolina

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.

Official title: Biofeedback for Fecal Incontinence and Constipation

Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Proportion of subjects reporting adequate relief per treatment group

Secondary outcome:

Demonstrate association of improvement in quality of life with treatment outcome

Identify predictors of successful treatment outcome

Describe physiological mechanism of treatment effects

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.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

University of North Carolina Department of Medicine, Chapel Hill, North Carolina 27599, United States

Related 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.

Starting date: September 1999
Ending date: June 2006
Last updated: August 24, 2007