Clinical Trial: Biofeedback Treatment for Functional Constipation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Biofeedback for Functional Constipation: Efficacy and Predictive Factors of Success

Brief Summary:

The purpose of this randomized, controlled trial is to examine how well biofeedback treatment works to improve constipation. The study is comparing two kinds of biofeedback treatment: 1) anorectal-specific biofeedback therapy and 2) generalized biofeedback therapy using relaxation techniques.

The study will also examine which medical and psychological factors determine biofeedback success for treating constipation, such as bowel habits, emotional reactions to constipation, and levels of stress and psychological distress.

Detailed Summary:

This is a randomized controlled trial (RCT) to evaluate the efficacy of anorectal biofeedback therapy for functional constipation secondary to pelvic floor dyssynergia. Participants will be randomized to either six sessions of anorectal biofeedback or to six sessions of generalized biofeedback.

Participants will complete questionnaires at baseline, at completion of randomized treatment(12 weeks), and six months after completion of treatment to measure change in bowel habits, constipation severity, constipation-related quality of life, and constipation-related disability. An examination of psychosocial factors will also be conducted prior to treatment to distinguish which ones are predictive of biofeedback success for functional constipation.

Sponsor: University of California, San Francisco

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, San Francisco

Dates:
Date Received: July 16, 2007
Date Started: March 2005
Date Completion:
Last Updated: June 24, 2010
Last Verified: August 2009