New Drug Being Tested for Painful Bladder Disease
UR Team Hopes to Validate New Drug Therapy for Interstitial Cystitis
July 23, 2002
Researchers at the University of Rochester Medical Center hope that a bacteria related to tuberculosis holds promise for the close to one million Americans—mostly women—that suffer from interstitial cystitis (IC), a debilitating and chronic bladder condition. Recently, a small study showed that Bacillus Calmette-Guérin (BCG) relieved the pelvic pain and frequent urination that are hallmarks of IC among 75 percent of study participants, even after the treatment dose ended. If this efficacy rate holds in the new study, BCG will become the best treatment option available to IC patients today.
Nine other institutions are involved in this National Institutes of Health-funded study, which will track the effects of BCG in 260 women over one year. Edward Messing, M.D., chairman of the urology department at the University of Rochester Medical Center, is the principal investigator of the research study. It was Messing who greatly heightened awareness of IC in 1978 by describing ways to diagnose the disease.
“We still do not know the cause of IC, nor have we found an effective treatment that will alleviate the pain and suffering of the majority of patients. In fact, the best treatment we have right now is only effective 30 to 40 percent of the time," Messing said. “With this study, we hope to confirm that BCG is indeed a promising treatment for women with IC.”
A Mysterious Disease
It's estimated that as many as one million Americans may experience pain and urgency consistent with interstitial cystitis. Physicians do not know why some people develop IC, and do not understand why it is a female-skewed disease—about 90 percent of all patients with IC are women. Symptoms vary from a relatively mild need to frequently urinate at night, to such severe pain that patients experience sleep deprivation. It is estimated that only about 50 percent of IC patients are able to work full time, accounting for $1.7 billion in lost wages and medical expenses. About a quarter of patients are younger than 30 years.
A leading medical theory behind IC is that it occurs when normal chemicals in the urine penetrate the normally impervious lining of the bladder and irritate cells deep inside the bladder wall. But researchers do not have a thorough understanding of how this leaky bladder defect occurs.
Nor is there an understanding of how BCG might be working on IC patients. A vaccine for tuberculosis and a treatment for superficial bladder cancer, research suggests BCG may stimulate a protective immune response and downplay a harmful one in the IC bladder. If BCG fulfills the promise of earlier studies, it could profoundly alter disease management and patients’ quality of life, which has been described as worse than being on kidney dialysis.
"Unfortunately, while this syndrome is now relatively easy to diagnose, it can be devastating for patients, both because of the severity of symptoms and our inability to treat it consistently," Messing said. “BCG has the very real potential of revolutionizing therapy for IC, because for the first time, IC patients will have a drug therapy available that will provide prolonged relief to the majority of sufferers.”
Participants in the study will be randomly assigned to have either a BCG or saline solution temporarily placed in the bladder during each of six clinic visits. Neither doctors nor patients will know who received the BCG until the study’s end. Patients whose symptoms are not relieved by the initial series will be offered open-label BCG.
IC patients are still needed for the study here in Rochester. Those who have been diagnosed with IC are asked to call 585/275-0126 to see if they are eligible to participate in the study.