NIH News Release
NATIONAL INSTITUTES OF HEALTH
National Institute of Diabetes
and Digestive and Kidney Diseases

FOR IMMEDIATE RELEASE
Monday, August 9, 1999

Contact: Mary Harris
(301) 496-3583
Mary_Harris@nih.gov

First NIH Clinical Trial for Interstitial Cystitis Begins
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 (Elmiron®) and hydroxyzine hydrochloride (Atarax®) to treat 136 people who have IC and unremitting urinary frequency and pain or discomfort lasting at least 24 weeks.

Elmiron® and Atarax® 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, Elmiron® reinforces the bladder lining, usually a barrier to urine's toxicity. Elmiron® is the only oral drug approved by the Food and Drug Administration for IC. Atarax® 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) Elmiron®, (3) Atarax®, or (4) both active drugs for 6 to 16 months, depending on when they join. At the end of the study, doctors will compare self-reported symptom improvement between the placebo group and drug groups.

"If the results are promising, we want to study more patients over a longer time. This would allow us to gather more solid information about the therapies and how we can help patients," says Nyberg. "And we are exploring other possible treatments to evaluate in subsequent trials."

J. Richard Landis, Ph.D., at the University of Pennsylvania School of Medicine in Philadelphia is coordinating data collection and analysis.

Notes: A fact sheet on IC is at http://www.niddk.nih.gov/health/urolog/pubs/cystitis/cystitis.htm. A list of centers and doctors is attached and at http://www.niddk.nih.gov/patient/studies.htm.


Interstitial Cystitis Clinical Trials Group

Maryland
John Warren, M.D.
University of Maryland, Baltimore
(410) 706-7560
New York
Edward M. Messing, M.D.
University of Rochester, Rochester
(716) 275-3345
Massachusetts
Grannum R. Sant, M.D.
Tufts University School of Medicine
New England Medical Center, Boston
(617) 636-7956
Oklahoma
Daniel J. Culkin, M.D.
University of Oklahoma,
Oklahoma City
(405) 271-6900
Michigan
Ananias C. Diokno, M.D.
William Beaumont Hospital, Royal Oak
(248) 551-0387

David Burks, M.D.
Henry Ford Hospital, Detroit
(313) 916-2075

Pennsylvania
Alan J. Wein, M.D.
University of Pennsylvania,
Philadelphia
Marilou Foy, R.N. C.C.R.C.
(215) 349-5874

Kristine E. Whitmore, M.D.
Graduate Hospital, Philadelphia
Marilou Foy, R.N., C.C.R.C.
(215) 349-5874