Biofeedback for Dyssynergic Constipation
Completed · Not applicable
Conditions studied: Constipation
In brief
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.
Key facts
- Study ID
- NCT00127257
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 117
- Starts
- 1999-09-01
- Expected to finish
- 2006-06-01
- Last updated by the study team
- 2010-01-13
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females ages 16 or above who have symptoms of constipation due to pelvic floor dyssynergia
You may not qualify if…
- Pregnancy (because of the possibility of randomization into the diazepam group)
- Prior history of biofeedback treatment for pelvic floor disorders
Where it is running
- University of North Carolina Department of Medicine — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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