Biofeedback Treatment for Functional Constipation

NCT ID: NCT00502957

Last Updated: 2010-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-11-30

Brief Summary

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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

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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.

Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Biofeedback

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* chronic constipation
* medical recommendation to undergo biofeedback training
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Principal Investigators

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Madhulika G Varma, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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Hart SL, Lee JW, Berian J, Patterson TR, Del Rosario A, Varma MG. A randomized controlled trial of anorectal biofeedback for constipation. Int J Colorectal Dis. 2012 Apr;27(4):459-66. doi: 10.1007/s00384-011-1355-9. Epub 2011 Dec 9.

Reference Type DERIVED
PMID: 22159695 (View on PubMed)

Other Identifiers

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H9654-26326

Identifier Type: -

Identifier Source: org_study_id

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