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Clinical Trials/NCT00502957
NCT00502957
Completed
Not Applicable

Biofeedback for Functional Constipation: Efficacy and Predictive Factors of Success

University of California, San Francisco1 site in 1 country15 target enrollmentMarch 2005
ConditionsConstipation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Constipation
Sponsor
University of California, San Francisco
Enrollment
15
Locations
1
Status
Completed
Last Updated
15 years ago

Overview

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 Description

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.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
November 2007
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • chronic constipation
  • medical recommendation to undergo biofeedback training

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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