Biofeedback for Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

Biofeedback for Fecal Incontinence and Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124904
• Other study ID #: RO1 DK57048a (completed)
• Status: Completed
• Phase: N/A
• First received: July 27, 2005
• Last updated: January 12, 2010
• Start date: September 1999
• Est. completion date: December 2006

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2006
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Behavioral:
• Biofeedback

• Kegel exercises

Locations

Country	Name	City	State
United States	University of North Carolina Department of Medicine	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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.

Outcome

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

External Links

•   Center website