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

Richard B. Alexander*, Kathleen J. Propert, Anthony J. Schaeffer, J. Richard Landis, J. Curtis Nickel, Michael P. O'Leary, Michel A. Pontari, Mary McNaughton-Collins, Daniel A. Shoskes, Craig V. Comiter, Nand S. Datta, Jackson E. Fowler, Robert B. Nadler, Scott I. Zeitlin, Jill S. Knauss, Yanlin Wang, John W. Kusek, Leroy M. Nyberg, Mark S. Litwin

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

192 Scopus citations

Abstract

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 α-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.

Original languageEnglish (US)
Pages (from-to)581-589
Number of pages9
JournalAnnals of internal medicine
Volume141
Issue number8
DOIs
StatePublished - Oct 19 2004

ASJC Scopus subject areas

  • Internal Medicine

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