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

Urology. 2003 Sep;62(3):425-9. doi: 10.1016/s0090-4295(03)00466-7.


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 = 0.01). 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 1 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.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adrenergic alpha-Antagonists / therapeutic use*
  • Adult
  • Aged
  • Chronic Disease
  • Double-Blind Method
  • Humans
  • Male
  • Middle Aged
  • Pain Measurement
  • Pelvic Pain / drug therapy
  • Pelvic Pain / etiology
  • Pilot Projects
  • Prospective Studies
  • Prostate-Specific Antigen / analysis
  • Prostatitis / complications
  • Prostatitis / diagnosis
  • Prostatitis / drug therapy*
  • Prostatitis / physiopathology
  • Quinazolines / therapeutic use*
  • Treatment Outcome
  • Urodynamics


  • Adrenergic alpha-Antagonists
  • Quinazolines
  • alfuzosin
  • Prostate-Specific Antigen