Ciprofloxacin or Tamsulosin in Men with Chronic Prostatitis/Chronic Pelvic Pain Syndrome

A Randomized, Double-Blind Trial

  1. Richard B. Alexander, MD;
  2. Kathleen J. Propert, ScD;
  3. Anthony J. Schaeffer, MD;
  4. J. Richard Landis, PhD;
  5. J. Curtis Nickel, MD;
  6. Michael P. O'Leary, MD;
  7. Michel A. Pontari, MD;
  8. Mary McNaughton-Collins, MD, MPH;
  9. Daniel A. Shoskes, MD;
  10. Craig V. Comiter, MD;
  11. Nand S. Datta, MD;
  12. Jackson E. Fowler, Jr, MD;
  13. Robert B. Nadler, MD;
  14. Scott I. Zeitlin, MD;
  15. Jill S. Knauss, MS;
  16. Yanlin Wang, MS;
  17. John W. Kusek, PhD;
  18. Leroy M. Nyberg, Jr, MD, PhD;
  19. Mark S. Litwin, MD, MPH; and
  20. and the Chronic Prostatitis Collaborative Research Network*
  1. From Veterans Affairs Maryland Health Care System and University of Maryland School of Medicine, Baltimore, Maryland; University of Pennsylvania and Temple University, Philadelphia, Pennsylvania; Northwestern University, Chicago, Illinois; Queen's University, Kingston, Ontario, Canada; Brigham and Women's Hospital and Massachusetts General Hospital, Boston, Massachusetts; Cleveland Clinic Florida, Weston, Florida; University of Arizona, Tucson, Arizona; Charles Drew University and University of California, Los Angeles, California; University of Mississippi, Jackson, Mississippi; and the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland.

    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 × 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.

    *For the members of the Chronic Prostatitis Collaborative Research Network, see the Appendix.

    Article and Author Information

    • Acknowledgments: The investigators are indebted to the patients who participated in this study.

    • Grant Support: By National Institutes of Health cooperative agreements U01 DK53572, U01 DK53730, U01 DK53736, U01 DK53734, U01 DK53732, U01 DK53746, and U01 DK53738. Boehringer Ingelheim provided tamsulosin and matching placebo; Bayer Corporation provided ciprofloxacin and matching placebo.

    • Potential Financial Conflicts of Interest:Consultancies: J.C. Nickel (Bayer, Boehringer Ingelheim), S.I. Zeitlin (Bayer); Honoraria: R.B. Alexander (Boehringer Ingelheim), J.C. Nickel (Bayer, Boehringer Ingelheim), D.A. Shoskes (Boehringer Ingelheim), S.I. Zeitlin (Bayer, Boehringer Ingelheim); Grants received: J.C. Nickel (Bayer, Boehringer Ingelheim); Other: S.I. Zeitlin (Bayer, Boehringer Ingelheim).

    • Requests for Single Reprints: Richard B. Alexander, MD, Urology (112), Veterans Affairs Maryland Health Care System, 10 North Greene Street, Baltimore, MD 21201; e-mail, ralexander{at}smail.umaryland.edu.

    • Current Author Addresses: Dr. Alexander: Urology (112), Veterans Affairs Maryland Health Care System, 10 North Greene Street, Baltimore, MD 21201.

    • Drs. Propert and Landis, Ms. Lang, and Ms. Knauss: Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Blockley Hall 6th Floor, 423 Guardian Drive, Philadelphia, PA 19104.

    • Drs. Schaeffer and Nadler: Department of Urology—Tarry 16-703, Feinberg School of Medicine, Northwestern University, 303 East Chicago Avenue, Chicago, IL 60611.

    • Dr. Nickel: Department of Urology, Queen's University, Kingston General Hospital, Kingston, Ontario K7L2V7, Canada.

    • Dr. O'Leary: Brigham and Women's Hospital, 45 Francis Street, ASB11-3, Boston, MA 02115.

    • Dr. Pontari: Department of Urology, Temple University School of Medicine, 3401 North Broad Street, Philadelphia, PA 19140.

    • Dr. McNaughton-Collins: General Medicine Division, Massachusetts General Hospital, 50 Staniford Street, 9th Floor, Boston, MA 02114.

    • Dr. Shoskes: Department of Urology, Cleveland Clinic Florida, 2950 Cleveland Clinic Boulevard, Weston, FL 33331.

    • Dr. Comiter: University of Arizona, 1501 North Campbell Avenue, Tucson, AZ 85724.

    • Dr. Datta: Martin Luther King Hospital, Charles Drew University, 12021 South Wilmington Avenue, Los Angeles, CA 90059.

    • Dr. Fowler: Department of Surgery, Division of Urology, University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216.

    • Dr. Zeitlin: University of California, Los Angeles, Department of Urology, 66-131 Center for the Health Sciences, Los Angeles, CA 90095.

    • Dr. Kusek: Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 617, 6707 Democracy Boulevard, Bethesda, MD 20892.

    • Dr. Nyberg: Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 627, 6707 Democracy Boulevard, Bethesda, MD 20892.

    • Dr. Litwin: University of California, Los Angeles, Department of Urology, 66-121 Center for the Health Sciences, Box 951738, Los Angeles, CA 90095.

    • Author Contributions: Conception and design R.B. Alexander, K.J. Propert, A.J. Schaeffer, J.R. Landis, J.C. Nickel, M.P. O'Leary, M.A. Ponteri, M. McNaughton-Collins, D.A. Shoskes, N.S. Datta, R.B. Nadler, S.I. Zeitlin, J.W. Kusek, L.M. Nyberg Jr., M.S. Litwin.

    • Analysis and interpretation of the data: R.B. Alexander, K.J. Propert, A.J. Schaeffer, J.R. Landis, J.C. Nickel, M.P. O'Leary, M. McNaughton-Collins, D.A. Shoskes, N.S. Datta, R.B. Nadler, S.I. Zeitlin, J.S. Knauss, Y. Wang, J.W. Kusek, M.S. Litwin.

    • Drafting of the article: R.B. Alexander, K.J. Propert, A.J. Schaeffer, J.C. Nickel, M.P. O'Leary, S.I. Zeitlin, J.W. Kusek, M.S. Litwin.

    • Critical revision of the article for important intellectual content: R.B. Alexander, K.J. Propert, A.J. Schaeffer, J.C. Nickel, M.P. O'Leary, M.A. Ponteri, M. McNaughton-Collins, D.A. Shoskes, R.B. Nadler, J.W. Kusek, M.S. Litwin.

    • Final approval of the article: R.B. Alexander, K.J. Propert, A.J. Schaeffer, J.R. Landis, J.C. Nickel, M.P. O'Leary, M.A. Ponteri, M. McNaughton-Collins, D.A. Shoskes, N.S. Datta, R.B. Nadler, L.M. Nyberg Jr., M.S. Litwin.

    • Provision of study materials or patients: R.B. Alexander, A.J. Schaeffer, J.C. Nickel, M.P. O'Leary, M.A. Ponteri, M. McNaughton-Collins, D.A. Shoskes, C.V. Comiter, N.S. Datta, J.E. Fowler Jr., R.B. Nadler, S.I. Zeitlin, M.S. Litwin.

    • Statistical expertise: K.J. Propert, J.R. Landis, J.S. Knauss, Y. Wang.

    • Obtaining of funding: A.J. Schaeffer, J.R. Landis, M.A. Ponteri, M. McNaughton-Collins, C.V. Comiter, J.W. Kusek, M.S. Litwin.

    • Administrative, technical, or logistic support: J.E. Fowler Jr., L.M. Nyberg Jr., M.S. Litwin.

    • Collection and assembly of data: R.B. Alexander, A.J. Schaeffer, J.C. Nickel, M.P. O'Leary, C.V. Comiter, R.B. Nadler, S.I. Zeitlin.

    Summary for Patients

    • Summaries for Patients:Treating Men with Chronic Prostatitis/Chronic Pelvic Pain Syndrome Ann Intern Med October 19, 2004 141:I-8
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    1. Ann Intern Med October 19, 2004 vol. 141 no. 8 581-589
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