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Completed

NCT Number: NCT00127257

Biofeedback for Dyssynergic Constipation

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.

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Key information

Conditions

Constipation Ataxia Dyskinesias Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina Department of Medicine

Chapel Hill, North Carolina, 27599, United States

About this study

This study is a long-term prospective, single-blind study comparing biofeedback for pelvic floor dyssynergia to a skeletal muscle relaxant drug (diazepam 5 mg two hours before attempted defecation) and to placebo medication. Prior to randomization, patients will first receive medical therapy (laxatives and education) for 4 weeks and only those remaining constipated will be randomized. Physiological tests of anal canal pressure during straining to defecate and ability to pass a 50-ml air filled balloon will be tested before and after treatment. Patients will keep a diary throughout baseline and treatment, and they will be reassessed at 3, 6, and 12 months follow-up. Treatment will consist of 6 clinic visits at 2-week intervals. The investigators will develop a detailed treatment manual for this disorder which would permit other investigators to replicate their study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females ages 16 or above who have symptoms of constipation due to pelvic floor dyssynergia

Exclusion criteria

  • Pregnancy (because of the possibility of randomization into the diazepam group)
  • Prior history of biofeedback treatment for pelvic floor disorders

Treatment and study plan

Biofeedback

Behavioral

Diazepam

Drug

Pelvic floor retraining

Behavioral

Primary outcomes

  1. Proportion of subjects reporting adequate relief per treatment group

Secondary outcomes

  1. Demonstrate association of improvement in quality of life with treatment outcome

  2. Identify predictors of successful treatment outcome

  3. Describe physiological mechanism of treatment effects

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

Biofeedback for Fecal Incontinence and Constipation

Important dates

Study start
1999
Study completion
2006
First posted
Aug 5, 2005
Registry last updated
Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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