Prostatitis is a chronic, disabling condition affecting untold numbers of men of all ages and ethnic origins. We will participate in the Chronic Prostatitis Collaborative Research Network (CPCRN). Long-term goals are to prevent and effectively treat this condition.
Specific aims are to cooperate and interact with the other clinical centers, the Data Coordinating Center (DCC) and NIDDK staff to: 1) establish a collaborative group of clinical trial centers with expertise in chronic pelvic pain, clinical pain management, and chronic prostatitis 2) design randomized controlled clinical trials to treat the symptoms associated with chronic prostatitis 3) develop and conduct ancillary studies, which will provide further understanding of chronic prostatitis 4) determine if there is a different response to therapy between sub-groups of patients, including newly diagnosed and chronic, long-term patients 5) recruit a sufficient numbers of patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), including an adequate number of newly diagnosed cases 6) jointly work with other CPCRN investigators, including the DCC, to analyze and interpret trial results 7) participate in the Urological Chronic Pelvic Pain Syndromes Collaborative Group (UCPPSCG) and 8) develop a clinically relevant definition of the urologic chronic pelvic pain syndromes, based on the clinical findings from these and other related clinical studies. Previous success in CP/CPPS studies allows us to meet the special requirements for this research including: the ability to recruit (and retain a high proportion of) at least 4-6 participants each month during years 2-4, the ability to recruit newly diagnosed cases, willingness to participate in a collaborative and interactive manner to develop the study protocols (both clinical trial and ancillary studies) and carry out the CPCRN trials, and willingness to participate in the UCPPSCG. We propose the following trial concept for consideration. Prior studies focused on refractory cases from tertiary referral centers. We propose to test the hypothesis that treatment outcomes in newly diagnosed cases are substantially better than in tertiary referral cases. We will screen the general population in Penang, Malaysia for new cases to compare with chronic cases from UW and other tertiary centers. Following clinical evaluation, CP/CPPS patients will be enrolled in a randomized clinical trial with a factorial design comparing alpha-blocker therapy, nonsteroidal anti-inflammatory therapy (or other therapies selected by the CPCRN), the combination, or placebo. Potential outcomes include: symptom indexes (e.g., the NIH-CPSI), urodynamics and inflammation.
