Efficacy and Safety of Udenafil Once Daily in Patients with Erectile Dysfunction after Bilateral Nerve-Sparing Robot-Assisted Laparoscopic Radical Prostatectomy: A Randomized, Double-Blind, Placebo-Controlled Study

Autor: Jae Hoon Chung, Tae Gyun Kwon, Cheol Kwak, Gyung Tak Sung, Soo Dong Kim, Jin Seon Cho, Hyung Jin Kim, Hanjong Ahn, Seong Soo Jeon
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: The World Journal of Men's Health, Vol 41, Iss 3, Pp 612-622 (2023)
Druh dokumentu: article
ISSN: 2287-4208
2287-4690
DOI: 10.5534/wjmh.220057
Popis: Purpose: To evaluate the efficacy and safety of udenafil 75 mg once daily in patients with erectile dysfunction following bilateral nerve-sparing robot-assisted laparoscopic radical prostatectomy (BNS-RALP). Materials and Methods: A multi-center, prospective, randomized, controlled, double-blind study was conducted. Among patients with localized prostate cancer with international index of erectile function-erectile function domain (IIEF-EF) score of 18 or higher before BNS-RALP, those who developed postoperative erectile dysfunction (IIEF-EF score 14 or less at 4 weeks after BNS-RALP) were enrolled. Enrolled patients were randomly assigned to the udenafil 75 mg daily group or the placebo group in a 2:1 ratio. Each subject was followed up at 8 weeks (V2), 20 weeks (V3), and 32 weeks (V4) to evaluate the efficacy and safety of udenafil. Results: In all, 101 patients were screened, of whom 99 were enrolled. Of the 99 patients, 67 were assigned to the experimental group and 32 to the control group. Ten (14.93%) patients in the experimental group and 10 (31.25%) in the control group dropped out of the study. After 32 weeks of treatment, IIEF-EF score of 22 or higher was seen in 36.51% (23/63) of patients in the experimental group and 13.04% (3/23) patients in the control group (p=0.021). The proportion of patients with IIEF-EF improvement of 25% or more compared to the baseline was 82.54% (52/63) in the experimental group and 62.96% (17/27) in the control group (p=0.058). Conclusions: Udenafil 75 mg once daily after BNS-RALP improved the erectile function without any severe adverse effects.
Databáze: Directory of Open Access Journals
Externí odkaz: