Constipation Clinical Trial
Official title:
Biofeedback for Fecal Incontinence and Constipation
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.
Status | Completed |
Enrollment | 117 |
Est. completion date | June 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina Department of Medicine | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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.
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. — View Citation
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.
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
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. — View Citation
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects reporting adequate relief per treatment group | |||
Secondary | Demonstrate association of improvement in quality of life with treatment outcome | |||
Secondary | Identify predictors of successful treatment outcome | |||
Secondary | Describe physiological mechanism of treatment effects |
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