To evaluate the efficacy and safety of silodosin on nocturia in patients with benign prostatic hyperplasia (BPH).
This was a 12-week, single-arm, open-label, prospective, multicenter study. The study included men 50 years or older with nocturia (≥2 events/night) based on a voiding diary, an International Prostate Symptom Score (IPSS) ≥8, and a quality of life score ≥3. Enrolled patients received 8 mg of silodosin once daily for 12 weeks. We evaluated changes in the mean number of nocturia episodes (using a voiding diary) from baseline to the final assessment. Safety assessments included the rate of adverse events and adverse drug reactions.
There were 118 patients included in the safety evaluation analysis, and 112 patients in the full analysis set group. The number of nocturia episodes decreased significantly after 12 weeks of treatment with silodosin (-1.12±1.05, P<0.0001). The secondary efficacy variables, including IPSS, overactive bladder symptom score and International Consultation on Incontinence Questionnaire-Nocturia score, also improved with treatment (P<0.0001). There were abnormal drug reactions in 11.8% of patients. The most common adverse drug reaction was an ejaculatory disorder (7.6%). There were no significant adverse drug reactions reported.
Silodosin was found to be safe and effective in the treatment of nocturia in patients with BPH.
Urology. 2018 Aug 08 [Epub ahead of print]
Kang Jun Cho, Jeong Zoo Lee, Yun Seob Song, Jong Bo Choi, Dae Kyung Kim, Yong Tae Kim, Joon Chul Kim
Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea., Department of Urology, Pusan National University, School of Medicine, Busan, Korea., Department of Urology, Soonchunhyang University Seoul Hospital, Soonchunghyang University College of Medicine, Seoul, Korea., Department of Urology, Ajou University school of Medicine, Suwon, Korea., Department of Urology, Eulji University School of Medicine, Daejeon, Korea., Department of Urology, Hanyang University College of Medicine, Seoul, Korea., Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea. Electronic address: .