Randomized Controlled Trial of Biofeedback Therapy for Dyssynergic Defecation

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT00257842
First received: November 21, 2005
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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 Intervention
Dyssynergia
Procedure: Standard treatment, sham feedback and biofeedback therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Iowa:

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00257842

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

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT00257842     History of Changes
Other Study ID Numbers: RO1 DK 57100-05
Study First Received: November 21, 2005
Last Updated: April 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ataxia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014