NCT00257842

Terminated

Randomized Controlled Trial of Biofeedback Therapy for Dyssy...

Augusta University Source

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Other study identifiers

Sponsor study identifier

R01DK057100-05

NIH

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 21, 2005
Actual (reported)
First Posted
November 23, 2005
Actual (reported)

Last Updated: September 17, 2014
Status Verified: September 2014
Last Update Submitted: September 16, 2014

Conditions

Dyssynergia

Interventions

Standard treatment, sham feedback and biofeedback therapyProcedure

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Eligibility Criteria

Age15 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Augusta University
Otherlead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

MeSH Terms

Conditions

Ataxia

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapy

Study Officials

Satish SC Rao, MD, PhD.
University of Iowa
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: pi

Study Record Dates

First Submitted

November 21, 2005

First Posted

November 23, 2005

Last Updated

September 17, 2014

Record last verified: 2014-09

Source record

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Source: ClinicalTrials.gov.

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