Constipation Clinical Trial
Official title:
Biofeedback for Functional Constipation: Efficacy and Predictive Factors of Success
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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