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

Completed

• Conditions: Chronic Prostatitis; Chronic Pelvic Pain Syndrome

• Registration Number: NCT01843946
• Lead Sponsor: The Catholic University of Korea

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-04
• Study First Submitted: 2013-04-27
• Study First Submitted QC: 2013-04-30
• Last Update Submitted: 2013-04-30
• Study First Posted: 2013-05-01
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Catholic University of Korea, St. Vincent's Hospital; 🇰🇷 Suwon, Korea, Republic of