(139) Efficacy of a New Vacuum Erection Device (Vigor 2020) for Erectile Dysfunction in a Retrospective Study in Japan

Phosphodiesterase 5 inhibitors (PDE5i) are the first-line treatment for erectile dysfunction (ED), but there is in approximately 30% of ineffective patients or contraindicated in patients taking nitrate medications. Although vacuum erection device (VED) is the second line in ED guidelines, they have long been unavailable in Japan, due to the withdrawal of their manufacturers. A new VED, Vigor 2020, has now been manufactured and received medical approval by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. It is very important to be able to sexual intercourse with VED, recommended in the ED guidelines. We conducted a retrospective observational study of patients with Vigor 2020 in clinical practice. We analyzed male patients aged 20 years or older who presented to an outpatient clinic with ED and were treated with Vigor 2020 as a second-line treatment, because PDE5i was ineffective or contraindicated. Sexual and ejaculatory function were assessed using questionnaires [Erection Hardness Score (EHS), International Index of Erectile Function (IIEF), Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ-EjD), the numerical rating scale (NRS)]. There were 34 participants who could be evaluated before and after the use of Vigor 2020, with a mean age of 57.85 (27–86) years. Significant improvement in EHS and IIEF total score were observed with the use of Vigor 2020 in all participants. There was a significant improvement in MSHQ-EjD and NRS for participants who had an EHS of 3 or higher after the use of Vigor 2020. But no significant improvement in MSHQ-EjD and NRS for participants who had an EHS of 2 or lower after the use of Vigor 2020. The participants experienced no significant adverse events. Vigor 2020 may be one treatment tool for ED, as defined in the ED guidelines. There is not only significant improvement of erection with Vigor 2020 but also improvement of ejaculation in cases of significant erectile efficacy. No.