Biofeedback Treatment for Functional Constipation
Primary Purpose
Constipation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring biofeedback, constipation
Eligibility Criteria
Inclusion Criteria:
- chronic constipation
- medical recommendation to undergo biofeedback training
Sites / Locations
- University of California, San Francisco
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00502957
First Posted
July 16, 2007
Last Updated
June 24, 2010
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00502957
Brief Title
Biofeedback Treatment for Functional Constipation
Official Title
Biofeedback for Functional Constipation: Efficacy and Predictive Factors of Success
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
biofeedback, constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic constipation
medical recommendation to undergo biofeedback training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhulika G Varma, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22159695
Citation
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.
Results Reference
derived
Learn more about this trial
Biofeedback Treatment for Functional Constipation
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