Silodosin is safe and effective for treating nocturia in men with benign prostatic hyperplasia (BPH), new study findings suggest.
Kang Jun Cho, MD, of The Catholic University of Korea in Seoul, and colleagues arrived at this conclusion based on a 12-week, single-arm, open-label prospective phase IV trial that included BPH patients aged 50 years or older with nocturia, defined as 2 or more nocturia events per night, based on a voiding diary. The men had an International Prostate Symptom Score (IPSS) of 8 or higher. The patients received 8 mg of silodosin once daily for 12 weeks.
The investigators included 118 patients in the safety evaluation analysis and 112 in the full analysis set group.
After 12 weeks of treatment, the mean number of nocturia episodes decreased significantly by 1.12, Dr Cho and colleagues reported in Urology. The investigators documented significant improvements in IPSS, overactive bladder symptom score, and International Consultation on Incontinence Questionnaire-Nocturia score. The most common adverse drug reaction was ejaculation disorder, occurring in 7.6% of patients. No significant adverse drug reactions were reported.
Cho KJ, Lee JZ, Song YS, et al. Evaluating the efficacy and safety of silodosin on nocturia in patients with benign prostatic hyperplasia: A multicenter, prospective, open-label, single-arm phase IV trial. Urology. Published online ahead of print.