Treatment of chronic prostatitis/chronic pelvic pain syndrome with tamsulosin: A randomized double blind trial

Purpose: We compared the efficacy of tamsulosin with placebo for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Materials and Methods: In a double blind phase II trial, 58 patients 55 years old or younger with moderate to severe CP/CPPS were randomized to receive 0.4 mg tamsulosin or placebo for 6 weeks. Patients were assessed on days -14 and -1 during a 2-week washout, and on days 15 and 45. The primary end point was the change from baseline in total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score on day 45. Secondary end points were the change from baseline in total NIH-CPSI score on day 15 and the change from baseline in pain, urinary symptoms and quality of life/impact domains of the NTH-CPSI on days 15 and 45. Analyses of responders were performed post hoe. Results: On day 45 the treatment effect (difference between treatment groups in change from baseline) was -3.6 (p=0.04) in favor of tamsulosin. The overall effect of tamsulosin was a function of the baseline total NIH-CPSI score. Treatment effect increased significantly as the baseline score increased (for total NIH-CPSI p<0.01). Tamsulosin efficacy was superior to placebo at the 75th percentile of baseline score for the total NIH-CPSI score (-8.3, p<0.01), the pain domain (-2.9, p=0.02), the urinary symptoms domain (-2.3, p<0.01) and the impact/quality of life domain (-2.1, p=0.02). The efficacy of tamsulosin increased with time (no significant treatment difference at 15 days) and tamsulosin was well tolerated. Conclusions: Tamsulosin was superior to placebo in providing symptomatic relief in men with CP/CPPS, particularly in those with more severe symptoms.