The Challenges of IC Research: Past, Present and Future.

• The Role of Hydrodistention May Change
• Future of Hydrodistention/ Cystoscopy
• Elmiron
• Potassium Sensitivity Testing
• BCG: Is it the Holy Grail for IC?
• The NIDDK Research Studies
• Current Study Information & Announcements

In 1987, the NIDDK established the first set of diagnostic criteria for interstitial cystitis. It focused on the presence of glomerulations (Click here for pictures) and/or Hunner's Ulcers on the bladder wall during hydrodistention, as well as the presence bladder pain, urinary frequency or urgency. The diagnostic criteria was designed to be strict and to be used primarily in IC research studies. However, it became a defacto definition for the disease for some urologists.

Is the NIDDK diagnostic criteria effective in a clinical setting? Dr. Payne is not the first physician to express concern that it failed to recognize patients with symptoms, yet no glomerulations. He said "SA Awads study in 1992 established that there is a subset of patients who had no cystoscopic findings for IC, yet had symptoms and responded to treatment."

"Waxmans study in Nov 1998 really got our attention and has questioned the very definition of IC," he continued. Released in the Journal of Urology (Cystoscopic findings consistent with interstitial cystitis in normal women undergoing tubal ligation - November, 1998), Waxman studied twenty women who were scheduled for tubal ligation and volunteered to be tested for the presence of glomerulations. Waxman found that 45% of these "normal" patients would have been classified as having IC even though they had no symptoms. In other words, he found that some normal patients have glomerulations. Dr. Payne offered "Hydrodistention may not be as important or as critical to the diagnosis of IC as we had thought."

The National Institutes of Health Interstitial Cystitis Database study provides some evidence which supports the diminished role of hydrodistention. The NIH studied a group of patients for four years to gain information on IC. Dr. Payne stated "They followed patients throughout the duration of the study but offered no intervention. They collected information from the physicians."

Hanno published the results of the study in the February 1999 Journal of Urology ("The diagnosis of interstitial cystitis revisited: lessons learned from the National Institutes of Health Interstitial Cystitis Database study") and found that 90% of the NIDDK patients were diagnosed by just by their case history via experienced clinicians. In addition, clinicians felt that 29% of the patients participating did not have IC and that 60% of patients might have been misdiagnosed based upon the strict NIDDK criteria. Dr. Payne summarized " The criteria was too strict.... hydrodistention was not critical in making a diagnosis."

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What is the future of hydrodistention?

In Parsons study, it was found that 32% of the patients had a 50% response versus 16% of placebo. Dr. Payne outlined additional problems in the original Elmiron Data. "It is poorly absorbed... only 3% is absorbed, most goes out in stool.... There was no test to measure the elmiron levels in blood or urine.. The research lasted only three months.... The end points were soft.... The European studies had low results."

In an effort to more thoroughly test Elmiron, there are 20 medical centers across the USA currently conducting higher dose and Elmiron effectiveness studies. These studies will be randomized double blinded. It will have three dosage groups (300mg, 600mg, 900mg). Treatment duration has been extended to eight months, significantly more than the original studies. They will also be assessing the effectiveness of potassium sensitivity testing. Results of the study will be based on data obtained from voiding diaries, patient assessments of their program and KCL results.

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Potassium Sensitivity Testing

Dr. Payne commended the BCG research of Dr. Ken Peters as the best IC study ever done. (Read the transcript from Dr. Peters 5/99 appearance on the ICN here). The study tested nine severe IC patients who had failed multiple therapies. Half received BCG and the other half water, for a total of six instillations. The initial results were promising, with a 60% response rate in contrast to a 27% placebo response.

Dr. Payne is currently participating in a new, much larger, national study testing BCG. Current studies have a strict protocol. Treatments will consist of six weekly instillations with evaluation at six months. It is a double blind, placebo study. At the end of the study, patients receiving placebo will be given the option of receiving BCG. They hope that these research studies will offer similar results to Dr. Peters initial studies, as well as to determine just how BCG works in an IC bladder.

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Current NIDDK Research Studies

Dr. Payne offered a somewhat cautious impression of the future of IC research. With the very definition of IC being questioned (i.e. the presence of glomerulations), he felt that today's clinical trials can make or break the future of IC research. He emphasized the benefits of clinical trials and encouraged IC patients to become involved. Clinical trials are essential because they promote IC treatments and additional IC research. They will establish the value and risk of therapies (i.e. for insurance company payments). Most importantly, they will provide a closer evaluation of IC and can create the foundation for new and improvement IC treatments."

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Current Study Information & Announcements

Dr. Payne is currently looking for patients to participate in his BCG, Elmiron or Menstrual Studies. For more information, please contact his office at: Christopher Payne, MD, Department of Neurourology, Clinical Science Building Room S287, Stanford University School of Medicine, Stanford, CA 94305. Phone: (650)723-3391

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