Comparison of Erectile Dysfunction Treatment Efficacy of Mirodenalfil 50mg Once Daily and 100mg On-Demand in Patients with Benign Prostatic Hyperplasia and Erectile Dysfunction: Multicenter, Randomized

ABSTRACT

PURPOSE: To Compare the improvement of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) as well as the efficacy of mirodenalfil 50mg once daily and 100mg on-demand in patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). MATERIALS AND METHODS: Prospective study was done with 220 patients who had BPH and ED from June 2013 to October 2014. Out of 220 individuals, 260 met inclusion criteria and 204 finished the research. Patients were divided into two groups. Group 1 had mirodenafil 50mg once daily and Group 2 had mirodenafil 100mg on-demand. The five-item version of the International Index of Erectile Function (IIEF-5), International Prostate Symptom Score (IPSS), Qmax, and residual urine volume(PVR) were assessed immediately before initiation of treatment (V1) and after four (V2) and twelve weeks of treatment (V3). RESULTS: No difference of IIEF-5, IPSS, Qmax, and PVR between two groups in V1. At V3, both groups had improvements of IPSS and group 1 had better improvements (-5.1+/-4.4 vs. -3.1+/-3.9 p<0.001). And Group 1 had larger improvements than Group 2 in Qmax significantly. No difference in PVR in both groups comparing V1 vs. V2 and V1 vs V3. Group 1 had better improved IIEF-5 than Group 2 (V1 vs. V3 4.8+/-5.8 vs. 4.4+/-5.1; p=0.032). There was no drop out patients due to cardiovascular problems. CONCLUSIONS: Once daily mirodenafil 50mg was more efficacious in treating both ED and LUTS than on-demand dosing mirodenafil 100mg without any complication of cardiovascular problems.