Randomized Controlled Trial of Biofeedback Therapy for Dyssynergic Defecation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00257842
Recruitment Status : Terminated
First Posted : November 23, 2005
Last Update Posted : September 17, 2014
Information provided by (Responsible Party):
Satish Rao, Georgia Regents University

Brief 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.

Condition or disease Intervention/treatment
Dyssynergia Procedure: Standard treatment, sham feedback and biofeedback therapy

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:Patients were included if they fulfilled Rome II criteria for functional constipation, and during attempted defecation demonstrated a dyssynergic pattern of defecation, and either had prolonged difficulty with expelling a simulated stool (> 1 minute) or prolonged delay (> 20% marker retention) in colonic transit.

Exclusion Criteria: They were required to have no evidence of structural or metabolic diseases that could cause constipation, as assessed by colonoscopy/barium enema and routine hematological, biochemical and thyroid function tests. Patients taking drugs known to be constipating, for example opioids were either excluded or were asked to discontinue the drug prior to enrollment. Other exclusion criteria included: severe cardiac or renal disease, previous gastrointestinal, spinal or pelvic surgery except cholecystectomy, hysterectomy or appendectomy, neurologic diseases such as multiple sclerosis, stroke or spinal injury, impaired cognizance (mini-mental score < 15), legal blindness, pregnancy, rectal prolapse, anal fissure, and alternating constipation and diarrhea.

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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 identifier (NCT number): NCT00257842

United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Augusta University
Principal Investigator: Satish SC Rao, MD, PhD. University of Iowa

Responsible Party: Satish Rao, pi, Georgia Regents University Identifier: NCT00257842     History of Changes
Other Study ID Numbers: R01DK057100-05 ( U.S. NIH Grant/Contract )
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014