Alfuzosin and Symptoms of Chronic Prostatitis–Chronic Pelvic Pain Syndrome

J. Curtis Nickel, M.D., John N. Krieger, M.D., Mary McNaughton-Collins, M.D., Rodney U. Anderson, M.D., Michel Pontari, M.D., Daniel A. Shoskes, M.D., Mark S. Litwin, M.D., Richard B. Alexander, M.D., Paige C. White, M.D., Richard Berger, M.D., Robert Nadler, M.D., Michael O'Leary, M.D., Men Long Liong, M.D., Scott Zeitlin, M.D., Shannon Chuai, Ph.D., J. Richard Landis, Ph.D., John W. Kusek, Ph.D., Leroy M. Nyberg, M.D., Anthony J. Schaeffer, M.D., for the Chronic Prostatitis Collaborative Research Network

ABSTRACT

Background In men with chronic prostatitis–chronic pelvic pain syndrome, treatment with alpha-adrenergic receptor blockers early in the course of the disorder has been reported to be effective in some, but not all, relatively small randomized trials.

Methods We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of alfuzosin, an alpha-adrenergic receptor blocker, in reducing symptoms in men with chronic prostatitis–chronic pelvic pain syndrome. Participation in the study required diagnosis of the condition within the preceding 2 years and no previous treatment with an alpha-adrenergic receptor blocker. Men were randomly assigned to treatment for 12 weeks with either 10 mg of alfuzosin per day or placebo. The primary outcome was a reduction of at least 4 points (from baseline to 12 weeks) in the score on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (range, 0 to 43; higher scores indicate more severe symptoms). A 4-point decrease is the minimal clinically significant difference in the score.

Results A total of 272 eligible participants underwent randomization, and in both study groups, 49.3% of participants had a decrease of at least 4 points in their total NIH-CPSI score (rate difference associated with alfuzosin, 0.1%; 95% confidence interval, –11.2 to 11.0; P=0.99). In addition, a global response assessment showed similar response rates at 12 weeks: 33.6% in the placebo group and 34.8% in the alfuzosin group (P=0.90). The rates of adverse events in the two groups were also similar.

Conclusions Our findings do not support the use of alfuzosin to reduce the symptoms of chronic prostatitis–chronic pelvic pain syndrome in men who have not received prior treatment with an alpha-blocker. (ClinicalTrials.gov number, NCT00103402 [ClinicalTrials.gov] .)