THE INTERSTITIAL CYSTITIS DATA-BASE STUDY - CONCEPTS AND PRELIMINARY BASE-LINE DESCRIPTIVE STATISTICS

Objectives. To describe the design, patient population, and data and s pecimen collection aspects of the Interstitial Cystitis Data Base (ICD B) Study and to provide preliminary descriptive statistics and inferen tial results from an interim analysis. Methods. All 424 study particip ants successfully enrolled in the ICDB Study prior to December 31, 199 5, were selected for an interim analysis and were classified into 1 of 3 symptom severity subgroups. Statistical tests for associations amon g these symptom severity subgroups and a broad range of baseline chara cteristics were conducted using Mantel-Haenszel procedures to adjust f or variation among clinical centers. Results. ICDB Study patients are predominantly female (91.5%), white (91.0%), with an average age at en rollment of 44.3 years. Nearly 45% of these patients underwent a cysto scopy at baseline screening, among whom there was an overall prevalenc e of 10.5% for Hunner's patch and 90% for glomerulations. Urodynamic e valuation for the entire 424 patients demonstrated that volumes at fir st sensation and at maximal capacity were inversely associated with sy mptom severity subgroups. A broad range of symptoms were analyzed, ind icating that nearly 40% of patients reported urinating 15 times or mor e during awake hours, and more than 20% reported voiding at least 4 ti mes per night. Almost half (47.9%) reported constant urgency and 23.6% reported having severe pain. Patients in the severe symptom subgroup reported greater limitations in selected quality-of-life indicators th an those with less severe symptoms. Conclusions. This interim analysis of the ICDB Study data was compared to previous epidemiologic studies of IC and provides an essential foundation for further analytic inves tigations of baseline associations and longitudinal trends. (C) 1997 b y Elsevier Science Inc.