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Biofeedback Treatment for Functional Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00502957
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : June 25, 2010
Sponsor:
Information provided by:
University of California, San Francisco

Study Description
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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.


Condition or disease Intervention/treatment Phase
Constipation Behavioral: Biofeedback Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biofeedback for Functional Constipation: Efficacy and Predictive Factors of Success
Study Start Date : March 2005
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic constipation
  • medical recommendation to undergo biofeedback training
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502957


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Madhulika G Varma, MD University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00502957    
Other Study ID Numbers: H9654-26326
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: June 25, 2010
Last Verified: August 2009
Keywords provided by University of California, San Francisco:
biofeedback
constipation
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive