Yu Seob Shin, Sung Won Lee, Kwangsung Park, Woo Sik Chung, Sae Woong Kim, Jae Seog Hyun, Du Geon Moon, Sang-Kuk Yang, Ji Kan Ryu, Dae Yul Yang, Ki Hak Moon, Kweon Sik Min, Jong Kwan Park
Department of Urology, Chonbuk National University Medical School, and Institute for Medical Sciences, Chonbuk National University and Biomedical Research Institute and Clinical Trial Center of Medical Device of Chonbuk National University Hospital, Jeonju 561-712, South Korea; Department of Urology, Sungkyunkwan University School of Medicine, Seoul, Korea; Department of Urology,Chonnam National University Medical School, Gwangju, Korea; Department of Urology, Ewha Womans University School of Medicine, Seoul, Korea; Department of Urology, The Catholic University of Korea College of Medicine, Seoul, Korea; Department of Urology, Gyeongsang National University School of Medicine, Jinju, Korea; Department of Urology, Korea University College of Medicine, Seoul, Korea; Department of Urology, Konkuk University School of Medicine, Chungju, Korea; Department of Urology, Inha University School of Medicine, Incheon, Korea; Department of Urology, Hallym University College of Medicine, Chuncheon, Korea; Department of Urology, Yeungnam University College of Medicine, Daegu, Korea; Department of Urology, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea
Introduction: To investigate the change of erection duration measured by stopwatch with flexible dose vardenafil administered for 8-week in subjects with erectile dysfunction (ED).
Material and methods: Effect of levitra on sustenance of erection (EROS) was an open-label, prospective, multicenter, single-arm study designed to measure the duration of erection in men with ED receiving a flexible dose of vardenafil over an 8-week treatment period. Patients were instructed to take vardenafil 10 mg 60 min prior to attempting intercourse. Vardenafil could be increased to 20 mg or decreased to 5 mg concerning patients’ efficacy and safety. Following initial screening, patients entered a 4-week treatment-free run-in phase and 8-week treatment period, during which they were instructed to attempt intercourse at least four times on 4 separate days.
Results: Ninety five men were enrolled in ten centers. During the 8-week treatment period, the mean duration of erection leading to successful intercourse was statistically superior when patients were treated with vardenafil.There were significant benefits with vardenafil in all domains of International Index of Erectile Function. Secondary efficacy end-points included success rate of penetration, maintaining, ejaculation, satisfaction were superior when patients were treated with vardenafil. There was a significant correlation between duration of erection with other sexual factors. Also partner’s sexual satisfaction increased with vardenafil. Most adverse events were mild or moderate in severity.
Conclusions: Vardenafil was safe and well tolerated. Vardenafil therapy provided a statistically superior duration of erection leading to successful intercourse in Korean men with ED with female partner.
Keywords: Stopwatch; vardenafil; phosphodiesterase type 5 (PDE5) inhibitor; erectile dysfunction (ED); partner
doi: 10.3978/j.issn.2223-4683.2014.s170
