Contact:Barbara Crawford ([email protected])
Ellen Beth Levitt ([email protected])
410-328-8919
UNIVERSITY OF MARYLAND BEGINS NIH-FUNDED CLINICAL TRIAL
FOR INTERSTITIAL CYSTITIS
Oral Drugs Studied for Painful Bladder Problem
Doctors at the University of Maryland Medical Center are seeking participants for a clinical trial to evaluate treatments for interstitial cystitis (IC), a persistent and often painful bladder syndrome affecting about a million people in the United States, mostly women.
The study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases, is being conducted at eight medical centers in the United States, including the University of Maryland Medical Center in Baltimore. Investigators will use two oral medications - pentosan polysulfate sodium (Elmiron) and hydroxyzine hydrochloride (Atarax) - to treat people who have IC and constant urinary frequency and pain or discomfort lasting at least 24 weeks.
"Interstitial cystitis can significantly impair a person's ability to handle daily activities," says John Warren, M.D., professor of medicine at the University of Maryland School of Medicine and head of the Division of Infectious Diseases. "Currently, there is no single therapy for interstitial cystitis that works effectively for a large number of patients. This study is the first of several trials that will enable us to recommend to physicians which therapies are the most effective for different groups of patients," says Dr. Warren, who is lead investigator of the study.
Elmiron and Atarax, both oral medications, were selected for testing because previous studies showed that they target different aspects of IC. In some patients, Elmiron reinforces the bladder lining, which usually creates a barrier to urine's toxicity. Elmiron is the only oral drug approved by the Food and Drug Administration for IC. Atarax is FDA-approved as an antihistamine. Atarax helps reduce the activity of certain cells that cause bladder inflammation and pain in IC patients. The two drugs may also work together, leading to quicker, more potent symptom relief.
Participants in the study will be divided into four groups and receive either a placebo, Elmiron only, Atarax only, or both drugs for 6 to 16 months, depending on when they join the study. At the end of the study, doctors will compare the symptom improvement of patients in the placebo group with those in the drug groups.
The cause of interstitial cystitis is unknown. Often mistaken for a bladder infection, IC may elude diagnosis for years. Unlike a bladder infection, IC comes and goes and is not caused by a bacteria. Symptoms of IC include the urge to pass urine when the bladder is not full, frequent urination and bladder pain.
"There are hundreds of thousands of IC sufferers whose lives may be significantly improved by more conclusive information about IC therapies," says Dr. Warren. "If the results of these trials are promising, larger studies will be conducted, which could have an important impact on the quality of life of IC patients."
For more information about the study or to find out about participation, please call 410-706-7560.
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