New Drug Trial for Interstitial Cystitis Begins

February 03, 1999

A study to determine the effectiveness of a new drug therapy against interstitial cystitis, is currently being conducted by researchers at the University of Rochester's Strong Memorial Hospital.

Nearly 500,000 million Americans, the majority of them women, suffer from interstitial cystitis (IC), a painful bladder disease characterized by urinary frequency, urgency, pelvic pain, difficulty voiding, and excessive urination during the nighttime hours. Interstitial cystitis is synonymous with poor quality of life and in some cases, sufferers become disabled. In Monroe County alone, as many as 250 people are believed to be afflicted with the disease.

Despite its existence for more than a century, interstitial cystitis continues to frustrate patients, physicians, and researchers alike. The disease has no known cause, and manifests itself through a number of different symptoms, including physical and psychological symptoms, which can also be indicative of other conditions. Diagnosis is further complicated by the fact that symptoms vary from patient to patient, with no definite pattern emerging. As a result, interstitial cystitis is often misdiagnosed as a pelvic disease, a urinary tract infection, prostatitis, or a gastrointestinal disorder.

"Increasing numbers of studies have been conducted over the last decade by investigators, but definitive knowledge about the disease continues to be elusive," said Robert D. Mayer, M.D., associate professor of urology and principal investigator of the Medical Center’s IC study. "The information that does exist has largely failed to suggest successful treatments for interstitial cystitis. Complete and sustained response to treatment is rare and unfortunately, symptom reduction is usually achieved only after patients undergo a lengthy series of failed treatments."

Several current treatments for IC exist, including a variety of drug therapies, surgery, exercise, diet modification, and electrical nerve stimulation, but the abundance of different therapies, coupled with their use in small patient populations and in uncontrolled studies, have experts continually questioning their efficacy.

The interstitial cystitis study at Strong Memorial Hospital seeks to determine the effectiveness of a new drug therapy, BCG. The abbreviated term for Bacillus Calmette-Guerin, BCG has been in existence for several years, used primarily to treat bladder cancer. "This is basically a new use for an existing drug, which we hope will prove to be successful," said Mayer.

The study will evaluate the success of 40 IC patients, half of who will receive BCG and the other half of whom will receive a placebo. The study is open to persons suffering from chronic IC symptoms, which have not responded well to antibiotic therapy. Participants are excluded from the study if they are suffering from a confirmed urinary tract infection, receiving chemotherapy for any type of cancer, taking the IC drug Elmiron, receiving anti-coagulation therapy, receiving chronic steroid therapy, or have a positive skin test for tuberculosis. In addition, participants must have experienced the symptoms of interstitial cystitis for nine months or longer.

Participants will receive a free physical exam, undergo bladder testing, and be evaluated from time to time by research staff. Mayer believes that when the study is completed, its results will shed light on more effective treatments for those suffering from interstitial cystitis.

Individuals interested in participating in the study can call the interstitial cystitis study office at (716) 275-2486.

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