Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
This is a randomized clinical trial study to test the efficacy and safety of amitriptyline in
the treatment of patients newly diagnosed with painful bladder syndrome (PBS). PBS is defined
by symptoms--frequent urination day and night and increasing pain as the bladder
fills--according to the International Continence Society. The syndrome includes interstitial
cystitis (IC), which has been estimated to affect as many as 700,000 people, mostly women.
Estimates for PBS vary widely, but as many as 10 million people may suffer from this
condition. Although amitriptyline is a Food and Drug Administration (FDA)-approved medication
used for depression, the way it works makes it useful for treating the pain of fibromyalgia,
multiple sclerosis, and other chronic pain syndromes. Prior small studies in interstitial
cystitis (IC) suggested the drug may be a wise choice for this syndrome as well, because it
blocks nerve signals that trigger pain and may also decrease muscle spasms in the bladder,
helping to relieve the symptoms of pain and frequent urination.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator:
University of Pennsylvania
Treatments:
Amitriptyline Amitriptyline, perphenazine drug combination