Alfuzosin treatment for chronic prostatitis/chronic pelvic pain syndrome:: A prospective, randomized, double-blind, placebo-controlled, pilot study

Objectives. To perform a prospective, placebo-controlled study to examine the long-term efficacy of alfuzosin compared with placebo and standard therapy in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), because alpha-blockers have been suggested for the treatment of CP/CPPS. Methods. One hundred twenty consecutive men diagnosed with CP/CPPS were prospectively screened and then asked to participate in a prostatitis treatment trial. Patients who agreed to be randomized were subsequently randomized to alfuzosin 5 mg twice daily or placebo and patients who agreed to participate but not be randomized were entered into a control or standard (except alpha-blockers) therapy group. Patients were prospectively treated for 6 months and then followed up for an additional 6 months. The change from baseline in the total and domain scores of the validated Finnish version of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) was the primary outcome parameter for this study. Results. Seventy subjects agreed to participate in the study. The data from 66 patients were available for evaluation (17 in the alfuzosin, 20 in the placebo, and 29 in the control/standard group). At the end of 6 months of active therapy, the alfuzosin group had had a statistically significant decrease in total NIH-CPSI score compared with the placebo and control/standard groups (9.9, 3.8, and 4.3 decrease, respectively, P = 0.0 1). A statistically significant improvement occurred in the pain score in the alfuzosin group at 6 months compared with the placebo and control/standard groups (P = 0.01), but not in the voiding or quality-of-life score among the three groups. Of the patients in the alfuzosin group, 65% had a greater than 33% improvement in the mean NIH-CPSI total score compared with 24% and 32% of the placebo and control/standard groups, respectively (P = 0.02). At 12 months (6 months after the alfuzosin/placebo treatment was discontinued), the symptom scores in all domains of the NIH-CPSI showed deterioration compared with original baseline score in the alfuzosin and placebo groups but not in the control/standard group (NIH-CPSI score 3.5, 0.1, and 5.6 points below baseline, respectively). Gastrointestinal symptoms and a decrease in ejaculate volume were noted by I and 4 patients, respectively, in the alfuzosin group. No patients dropped out of the study because of an adverse event. Conclusions. Six months of alfuzosin therapy for CP/CPPS is safe and well tolerated and results in a modest, but statistically significant, improvement in the NIH-CPSI, particularly in the pain domain, compared with placebo and standard/traditional treatment. The beneficial effect is only apparent after several months of treatment and disappears when treatment is discontinued.