Fecal Incontinence Clinical Trial
Official title:
Biofeedback for Fecal Incontinence and Constipation
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.
Status | Completed |
Enrollment | 165 |
Est. completion date | December 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 |
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, Ringel Y, Scarlett Y, Whitehead WE. Biofeedback treatment of fecal incontinence: a critical review. Dis Colon Rectum. 2001 May;44(5):728-36. — 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. 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. Psychological and cognitive variables affecting treatment outcomes for urinary and fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S146-51. Review. — View Citation
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.
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 |
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