Clinical Efficacy of Roxithromycin in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Overview

Roxithromycin is effective in the treatment of intracellular organisms, including chlamydia and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory diseases. To explore the potential therapeutic benefit of roxithromycin in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), this study compared the effect of roxithromycin with ciprofloxacin and aceclofenac.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2012

Detailed Description

A total of 75 patients with CP/CPPS were randomized to three groups in open-label: group 1, ciprofloxacin; group 2, aceclofenac; and group 3, roxithromycin. The patients were treated for 4 weeks and were subsequently followed for 12 weeks. Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated.

Clinical Trial Outcome Measures

Primary Measures

  • NIH-CPSI score
    • Time Frame: 12 weeks
    • Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of category IIIa of IIIb chronic prostatitis – NIH-CPSI (National Institute of Health Chronic Prostatitis Symptom Index) score ≥ 15 Exclusion Criteria:

  • Urinary tract infection or uropathogen within the past 12 months – Serious medical problems – NIH consensus exclusion criteria13 (presence of active urethritis, urogenital cancer, urinary tract disease, functionally significant urethral stricture, neurological disease affecting the bladder, etc.) – Drug therapy that might affect lower urinary tract functions within the past 3 months

Gender Eligibility: Male

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Catholic University of Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hyun-Sop Choe, Doctor – The Catholic University of Korea
  • Overall Official(s)
    • Hyun-Sop Choe, Dr, Principal Investigator, Saint Vincent’s Hospital, Korea

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