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

J Urol. 2004 Apr;171(4):1594-7. doi: 10.1097/01.ju.0000117811.40279.19.


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 NIH-CPSI on days 15 and 45. Analyses of responders were performed post hoc.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenergic alpha-1 Receptor Antagonists*
  • Adult
  • Chronic Disease
  • Double-Blind Method
  • Humans
  • Male
  • Middle Aged
  • Pelvic Pain / drug therapy*
  • Pelvic Pain / etiology
  • Pilot Projects
  • Prostatitis / complications
  • Prostatitis / drug therapy*
  • Sulfonamides / therapeutic use*
  • Syndrome
  • Tamsulosin


  • Adrenergic alpha-1 Receptor Antagonists
  • Sulfonamides
  • Tamsulosin