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Randomized Controlled Trial of Biofeedback Therapy for Dyssynergic Defecation

NCT00257842 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-09-17

No results posted yet for this study

Summary

Constipation is a common disorder and current treatments are unsatisfactory. Biofeedback may help patients with constipation and dyssynergic defecation, but its efficacy is unproven and whether this is due to behavioral modification or excessive attention is unknown. Methods: In a prospective randomized trial, the investigators investigated the efficacy of Biofeedback (manometric- assisted anal relaxation, muscle coordination and simulated defecation training), with either sham feedback therapy (Sham) or standard therapy (diet, exercise, laxatives; Standard) in 77 subjects (69 women) with dyssynergic defecation. Primary outcome measures included presence of dyssynergia, balloon expulsion time, number of complete spontaneous bowel movements (CSBM), and global bowel satisfaction. Data analyzed per protocol.

Conditions

  • Dyssynergia

Interventions

PROCEDURE

Standard treatment, sham feedback and biofeedback therapy

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Satish SC Rao, MD, PhD. · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00257842 on ClinicalTrials.gov