Overview

Biofeedback for Dyssynergic Constipation

Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
Diazepam
Criteria
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