The primary objectives of this proposal are to initiate a collaborative study to develop an interstitial cystitis (IC) database through the collection and analysis of information and clinical samples from patients with the disorder. The objectives will be attained by: (1) Designing a protocol and manual of operations in conjunction with a Steering Committee, consisting of members of the clinical centers, data coordinating center, and the NIDDK project coordinator. The database protocol will contain alll information required to apply the interstitial cystitis diagnostic criteria which were established at the NIH workshop on interstitial cystitis. (2) Recruiting and admitting patients into the study who meet agreed upon diagnostic entry criteria, have standard demographic information, symptoms related to interstitial cystitis, and clinical samples collected from them at established intervals.
The specific aims of the patient database are: (1) To identify the age, sex, race, and other demographic characteristics of patients with interstitial cystitis. (2) To determine the natural history of the disorder. (3) To collect and distribute patient samples and to analyze bladder biopsies. (4) To act as a data and patient sample repository for use by other investigators wishing to conduct epidemiological and clinical studies. Our center will recruit a minimal of 50 patients. The principal investigator (Dr. Anthony J. Schaeffer, Northwestern University Medical School) and co-investigator (Dr. Edward M. Messing, University of Wisconsin) each have more than 10 years of experience in diagnosis and treatment of IC, are highly qualified to identify patients with IC, and have large patient populations and potential referral populations to meet these needs. The NIH diagnostic criteria for IC that have been established and published (Journal of Urology 142 (1): 139, 1989) will be utilized. There will be an initial 5 month period of collaborative protocol development prior to patient enrollment, 48 months of patient recruitment, and 6 months of final data analysis and reporting of results at the conclusion of recruitment. The data obtained from this study will improve our understanding of the pathogenesis and management of IC.
