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

The Catholic University of Korea75 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Prostatitis Chronic Pelvic Pain Syndrome

Eligibility

Sex: MALEHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The Catholic University of Korea, St. Vincent's Hospital

Suwon, South Korea

Outcomes

Primary Outcomes

NIH-CPSI score

Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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