Biofeedback Treatment for Functional Constipation
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|ClinicalTrials.gov Identifier: NCT00502957|
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : June 25, 2010
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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.
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Behavioral: Biofeedback||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biofeedback for Functional Constipation: Efficacy and Predictive Factors of Success|
|Study Start Date :||March 2005|
|Actual Study Completion Date :||November 2007|
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.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- chronic constipation
- medical recommendation to undergo biofeedback training
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
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Madhulika G Varma, MD||University of California, San Francisco|
|Other Study ID Numbers:||
|First Posted:||July 18, 2007 Key Record Dates|
|Last Update Posted:||June 25, 2010|
|Last Verified:||August 2009|
Signs and Symptoms, Digestive