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Biofeedback for Dyssynergic Constipation

NCT00127257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2010-01-13

No results posted yet for this study

Summary

Constipation affects 4% of adults in the United States (U.S.). An estimated half of constipated patients are unable to relax pelvic floor muscles during defecation, a type of constipation called pelvic floor dyssynergia (PFD). Biofeedback has been recommended for the treatment of constipation because uncontrolled studies over the past 10 years suggest that these treatments are as effective as medical or surgical management and involve no risk. However, placebo-controlled trials are still lacking. The aims of this study are:

* to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit;
* to identify which patients are most likely to benefit; and
* to assess the impact of treatment on quality of life.

Conditions

Interventions

BEHAVIORAL

Biofeedback

DRUG

Diazepam

BEHAVIORAL

Pelvic floor retraining

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • William E Whitehead, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-09-30
Completion
2006-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00127257 on ClinicalTrials.gov