The primary objectives of this proposal are to continue our participation in the Interstitial Cystitis Clinical Research Network (ICCRN), (formerly Interstitial Cystitis Clinical Trials Group) in order to develop and conduct randomized controlled multicenter studies of therapies for interstitial cystitis. The objectives will be achieved by: a. Establishment of a collaborative group of clinical trials centers with clinical expertise in chronic pelvic pain, clinical pain management and interstitial cystitis. b. Development and design of randomized therapy protocols for interstitial cystitis. c. Development and completion of ancillary studies that will provide further understanding of interstitial cystitis. d. Determination if there is a different response to therapy between newly diagnosed and chronic, long term patients with the disorder. e. Recruitment of sufficient numbers of patients into these clinical trials. f. Collaboration with other ICCRN sites and Data Coordinating Center to analyze and interpret results. g. Participation in the Urological Chronic Pelvic Pain Syndrome Collaborative Group to facilitate clinical trials and to develop a clinically relevant definition of the urologic chronic pelvic pain syndromes. There will be an initial 12-month period of collaborative protocol/manual operations development followed by 48 months of patient recruitment with concurrent data analysis and reporting. The data obtained from these randomized controlled studies will define the effectiveness of various therapies for interstitial cystitis, further our understanding of the factors initiating the diseases' development, progression, remissions and responses(s) to treatment and improve the quality of life of patients suffering from interstitial cystitis.
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