Silodosin is safe and effective for treating lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH), findings from a European phase 4 study published online ahead of print in the International Journal of Urology.

The study, by Francesco Montorsi, MD, of IRCCS Ospedale San Raffaele in Milan, Italy, and colleagues, included 1,036 men aged 60 years and older with BPH and an International Prostate Symptom Score (IPSS) of 12 or higher. Patients received silodosin 8 mg for 24 weeks.

Of the 1,036 patients, 766 (77.1%) had a 25% or greater decrease in IPSS, the primary endpoint of the study. The mean IPSS decreased from 18.9 to 10.6. The storage subscore declined from 8.1 to 4.9 and the voiding subscore decreased from 10.8 to 5.7. The mean IPSS quality of life suubscore decreased from 4.0 to 2.2. Results showed that 74.2% of men were satisfied with treatment.

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