Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial

Ann Intern Med. 2004 Oct 19;141(8):581-9. doi: 10.7326/0003-4819-141-8-200410190-00005.


Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in men is principally defined by pain in the pelvic region lasting more than 3 months. No cause of the disease has been established, and therapies are empirical and mostly untested. Antimicrobial agents and alpha-adrenergic receptor blockers are frequently used.

Objective: To determine whether 6-week therapy with ciprofloxacin or tamsulosin is more effective than placebo at improving symptoms in men with refractory, long-standing CP/CPPS.

Design: Randomized, double-blind trial with a 2 x 2 factorial design comparing 6 weeks of therapy with ciprofloxacin, tamsulosin, both drugs, or placebo.

Setting: Urology outpatient clinics at 10 tertiary care medical centers in North America.

Patients: Patients were identified from referral-based practices of urologists. One hundred ninety-six men with a National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 15 and a mean of 6.2 years of symptoms were enrolled. Patients had received substantial previous treatment.

Measurements: The authors evaluated NIH-CPSI total score and subscores, patient-reported global response assessment, a generic measure of quality of life, and adverse events.

Interventions: Ciprofloxacin, 500 mg twice daily; tamsulosin, 0.4 mg once daily; a combination of the 2 drugs; or placebo.

Results: The NIH-CPSI total score decreased modestly in all treatment groups. No statistically significant difference in the primary outcome was seen for ciprofloxacin versus no ciprofloxacin (P = 0.15) or tamsulosin versus no tamsulosin (P > 0.2). Treatments also did not differ significantly for any of the secondary outcomes.

Limitations: Treatment lasting longer than 6 weeks was not tested. Patients who had received less pretreatment may have responded differently.

Conclusion: Ciprofloxacin and tamsulosin did not substantially reduce symptoms in men with long-standing CP/CPPS who had at least moderate symptoms.

Publication types

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

MeSH terms

  • Adrenergic alpha-Antagonists / therapeutic use*
  • Adult
  • Anti-Infective Agents / therapeutic use*
  • Chronic Disease
  • Ciprofloxacin / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Humans
  • Male
  • Middle Aged
  • Pelvic Pain / drug therapy*
  • Placebos
  • Prostatitis / drug therapy*
  • Sulfonamides / therapeutic use*
  • Syndrome
  • Tamsulosin
  • Treatment Failure


  • Adrenergic alpha-Antagonists
  • Anti-Infective Agents
  • Placebos
  • Sulfonamides
  • Ciprofloxacin
  • Tamsulosin