Elsevier

Urology

Volume 59, Issue 6, June 2002, Pages 870-876
Urology

Adult urology
Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome1 ,

https://doi.org/10.1016/S0090-4295(02)01601-1Get rights and content

Abstract

Objectives. To describe the study design and rationale for the first placebo-controlled, randomized clinical trial to be conducted by the Chronic Prostatitis Collaborative Research Network sponsored by the National Institutes of Health.

Methods. The clinical trial will use a 2 by 2 factorial design to evaluate four treatments: placebo, tamsulosin hydrochloride alone, ciprofloxacin alone, and tamsulosin hydrochloride and ciprofloxacin combined. The primary objectives are to compare the efficacy and safety endpoints in patients with chronic prostatitis/chronic pelvic pain syndrome. The study population consists of men with symptoms of discomfort or pain in the pelvic region for at least a 3-month period. One hundred eighty-four participants will be treated for 6 weeks and followed up for an additional 6 weeks. The primary endpoint is the change in the overall National Institutes of Health Chronic Prostatitis Symptom Index from baseline to 6 weeks. Secondary endpoints include a patient-reported global assessment of response and white blood cell counts and cultures in urine, expressed prostatic secretions, and semen. The evaluation of changes from 6 to 12 weeks will be used to assess the durability of the response.

Results. This trial was opened to enrollment in July 2001. The study is expected to require 14 months of accrual and follow-up.

Conclusions. The issues considered in the design of this clinical trial may provide guidelines for future clinical trials in chronic prostatitis/chronic pelvic pain syndrome.

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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  • Cited by (0)

    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.

    1

    A complete list of the Chronic Prostatitis Collaborative Research Network participants is given in the Appendix.

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