Biofeedback for Dyssynergic Constipation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Constipation |
Behavioral: Biofeedback Drug: Diazepam Behavioral: Pelvic floor retraining |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Biofeedback for Fecal Incontinence and Constipation |
- Proportion of subjects reporting adequate relief per treatment group
- Demonstrate association of improvement in quality of life with treatment outcome
- Identify predictors of successful treatment outcome
- Describe physiological mechanism of treatment effects
| Estimated Enrollment: | 117 |
| Study Start Date: | September 1999 |
| Estimated Study Completion Date: | June 2006 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| University of North Carolina Department of Medicine | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | William E Whitehead, PhD | University of North Carolina, Chapel Hill |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00127257 History of Changes |
| Other Study ID Numbers: | RO1 DK57048b (completed) |
| Study First Received: | August 4, 2005 |
| Last Updated: | January 12, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
Constipation Biofeedback Dyssynergia Pelvic floor dyssynergia Outlet dysfunction |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms Diazepam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Hypnotics and Sedatives |
Central Nervous System Depressants Muscle Relaxants, Central Neuromuscular Agents Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia |
ClinicalTrials.gov processed this record on May 23, 2013