Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-05 @ 5:52 PM
Study NCT ID:
NCT00502957
Status:
COMPLETED
Last Update Posted:
2010-06-25
First Post:
2007-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biofeedback Treatment for Functional Constipation
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Biofeedback for Functional Constipation: Efficacy and Predictive Factors of Success
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: