Adult urologyDesign of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome1 ☆,
Section snippets
Study organizations
The CPCRN currently consists of 10 clinical centers that will recruit participants for the trial, a Data Coordinating Center, and representatives from the NIDDK. The CPCRN External Advisory Committee serves as the Data Safety and Monitoring Board for this trial.
Study design
This placebo-controlled, double-blind, randomized clinical trial will use a 2 by 2 factorial design to evaluate the following four treatments: placebo, tamsulosin hydrochloride alone, ciprofloxacin alone, and the combination of
Choice of patient population
The trial entry criteria allow for the evaluation of a homogeneous group of men in whom other factors that could confound analysis of treatment effect are excluded. The target population for all CPCRN clinical trials is patients with symptoms consistent with CP/CPPS, specifically Category III.1 Although up to 98% of these patients have previously received antimicrobial therapy,5 such treatment has rarely resulted in durable, complete symptom remission. This population of men represents the
Conclusions
Ideally, the results of this clinical trial will guide recommendations for the standard treatment of CP/CPPS and possibly suggest a “control” arm for future studies of CP/CPPS. This trial will also provide valuable information for the design and conduct of clinical trials of CP/CPPS. Furthermore, although subgroup analyses in a clinical trial should be primarily hypothesis generating, secondary analyses of this trial may also provide some insight into the pathogenesis of symptoms. For example,
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This study was supported by grants R01 DK53736, R01 DK53752, R01 DK53732, R01 DK53730, R01 DK53734, and R01 DK53746 from the National Institute of Diabetes, Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.