Oral drugs studied for painful bladder problem

Doctors have opened enrollment for a clinical trial of oral drugs for interstitial cystitis (IC), a persistent and often painful bladder syndrome affecting about a million people, mostly women.

The Interstitial Cystitis Clinical Trials Group will use pentosan polysulfate sodium (ElmironR) and hydroxyzine hydrochloride (AtaraxR) to treat 136 people who have IC and unremitting urinary frequency and pain or discomfort lasting at least 24 weeks.

ElmironR and AtaraxR were selected first for testing because patients prefer oral treatments and studies suggest that each drug uniquely targets different aspects of IC. In some patients, ElmironR reinforces the bladder lining, usually a barrier to urine's toxicity. ElmironR is the only oral drug approved by the Food and Drug Administration for IC. AtaraxR is an antihistamine that reduces the activity of mast cells, which may cause bladder inflammation and pain. The two drugs may also work synergistically, leading to quicker, more potent symptom relief.

"IC leaves many people unable to cope with basic daily functions," says Leroy M. Nyberg Jr., Ph.D., M.D., director of urology research at the National Institute of Diabetes and Digestive and Kidney Diseases, which is funding the clinical trial. "This is the first of a series of rigorous treatment trials. Our ultimate goal is to be able to recommend to physicians those therapies most likely to relieve symptoms in subgroups of patients." The cause of interstitial cystitis is unknown and no one therapy works effectively in a large number of patients. Often mistaken for a bladder infection, IC may elude diagnosis for years.

Clinical trial participants will be divided into four groups to receive either (1) a placebo, (2) ElmironR, (3) AtaraxR, or (4) both active drugs for 6 to 16 months, depending on when they join. A
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Contact: Mary Harris
HarrisMM@extra.niddk.nih.gov
301-496-3583
NIH/National Institute of Diabetes and Digestive and Kidney Diseases
9-Aug-1999