Korean J Urol Oncol.  2015 Dec;13(3):115-121. 10.0000/kjuo.2015.13.3.115.

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

Affiliations
  • 1Department of Urology, Hanyang University College of Medicine, Seoul, Korea. swleepark@hanyang.ac.kr
  • 2Department of Urology, Dong-A University College of Medicine, Busan, Korea.
  • 3Department of Urology, Kwangju Christian Hospital, Gwangju, Korea.
  • 4Department of Urology, Korea University College of Medicine, Seoul, Korea.
  • 5Department of Urology, Hanlim University College of Medicine, Seoul, Korea.
  • 6Department of Urology, Yonsei University College of Medicine, Seoul, Korea.
  • 7Department of Urology, Seoul National University College of Medicine, Seoul, Korea.
  • 8Department of Urology, KEPCO Medical Center, Seoul, Korea.

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.

Keyword

Mirodenafil; Lower urinary tract symptoms; Erectile dysfunction; Benign prostatic hyperplasia

MeSH Terms

Erectile Dysfunction*
Humans
Lower Urinary Tract Symptoms
Male
Outpatients
Prospective Studies
Prostate
Prostatic Hyperplasia*
Treatment Outcome*
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