This study is designed to form an interactive research network of clinical centers to develop and conduct randomized clinical trials to evaluate novel therapies in patients with category III prostatitis. The research group will conduct ancillary studies to investigate the etiology and pathogenesis of chronic prostatitis, and also participate with researchers performing similar studies in patients with Interstitial Cystitis (IC) in an organization which will investigate both entities. This is a proposal to be chosen as one of the clinical centers which will be carrying out these studies. Temple University is particularly qualified to do so for a number of reasons. We have extensive experience with both Chronic Prostatitis and Interstitial Cystitis, and were one of the participating centers in the Chronic Prostatitis Collaborative Research Network (CPCRN). We have been very successful in past clinical trials recruiting and retaining men for studies of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The investigators have expertise in both clinical and basic science investigation in chronic pelvic pain. We are located in an urban area and have access to a large minority population. To fulfill the aims of this study we propose a randomized placebo controlled trial of an antidepressant medication which has shown efficacy in chronic neuropathic pain conditions. We have detailed our experience with successfully recruiting and retaining men for trials of chronic prostatitis, as well as our experience with pitfalls in trial design. Plans for subgroups analyses are provided. We will also participate in the Urologic Chronic Pelvic Pain Syndromes Collaborative Group. We provide evidence of our ongoing interest and studies in the comparison and characterization of both CP/CPPS and IC. Issues in developing a clinically relevant definition of urologic chronic pelvic pain syndromes are discussed.
| Pontari, Michel A; Krieger, John N; Litwin, Mark S et al. (2010) Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial. Arch Intern Med 170:1586-93 |
| Nickel, J Curtis; Alexander, Richard B; Anderson, Rodney et al. (2008) Category III chronic prostatitis/chronic pelvic pain syndrome: insights from the National Institutes of Health Chronic Prostatitis Collaborative Research Network studies. Curr Urol Rep 9:320-7 |
| Nickel, J Curtis; Krieger, John N; McNaughton-Collins, Mary et al. (2008) Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome. N Engl J Med 359:2663-73 |
