ABSTRACT
INTRODUCTION: Benign prostatic hyperplasia (BPH) is one of the most common diseases in men over 50 years. The prevalence of the BPH increases with age, and pathologic features of BPH are found in about 90% of men over 80 years. AIM: The aim of the study was to study the efficacy and safety of Afalaza for the treatment of lower urinary tract symptoms (LUTS) in treatment-nave patients with BPH. MATERIALS AND METHODS: A multicenter study of using Afalaza for the treatment of LUTS in treatment-nave patients with BPH was carried out in 9 urological centers in Moscow. A total of 80 treatment-nave patients with BPH were enrolled. The improvement in the total score of IPSS, IIEF-5 and QoL after 30 weeks of therapy was evaluated as well as changes in prostate volume and maximum urinary flow rate (Qmax). RESULTS: After 30 weeks of therapy, there was a significant decrease in the total IPSS score. A decrease in the total IPSS score by 5.5 points (+37.9%) from 14.5+/-4.0 at the baseline to 9.0+/-4.1 at the visit 9 was seen. The QoL decreased by 1.8 (-38.3%) points from 4.7+/-1.0 at the baseline. The Qmax also changed from 12.7+/-4.6 to 16.4+/-5.7 (+28.3%) after 30 weeks of therapy. At the visit 9, the total IIEF5 score increased by 3.4+/-4.4 (+19.9%) from 17.1+/-4.3 at the baseline. In addition, prostate volume decreased from 42.7+/-11.1 at baseline to 41.0+/-9.8 cc post-treatment (-5.15%). A reduction of post-void residual urine volume from 26.0+/-25.3 at baseline to 17.7+/-24.2 (-31.9%) post-treatment was also shown. CONCLUSION: The results of a multicenter study demonstrate the efficacy of Afalaza for treatment of treatment-nave patients with LUTS/BPH. Afalaza reduces prostate volume and improves an erectile function.
