An observational study to monitor the efficacy and tolerability of levofloxacin 500 mg once daily for treatment of chronic bacterial prostatitis in Saudi Arabia

INTRODUCTION: Chronic prostatitis is a common urological problem in men <50-year-old. Untypical uropathogens and an intact blood prostate barrier cause difficulty in using antibiotics to treat the infection. PATIENTS AND METHODS: In this open-label, observational study, levofloxacin 500 mg was given once daily for 28 days for treatment of chronic prostatitis. The primary efficacy measurement was the disappearance of all pre-treatment symptoms. Efficacy analysis is based on the per protocol population (PPP), all other analyses use the intent to treat (ITT) population. RESULTS: The ITT included 154 men and the PPP included 151 (results are for the ITT unless otherwise indicated). Mean age was 42 ± 9 years, common concomitant conditions were diabetes mellitus (7%) and hypertension (5%). All symptoms decreased at day 28. Notably, the rate of dysuria decreased from 86.1% to 10.6%, painful ejaculation from 71% to 2.6% and perineal discomfort from 60.3% to 7.3%. A cure of condition was identified in 58.9%. No treatment failures were reported. Physician-reported adherence to study medication was 96.8%. CONCLUSION: Levofloxacin appears to be an effective antibiotic for treating symptoms of chronic bacterial prostatitis. Levofloxacin was well-tolerated in this population.