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Objectives The vacuum erection device (VED) is a second‐line treatment tool recommended in erectile dysfunction (ED) guidelines but has long been unavailable in Japan. A new VED, Vigor 2020 ® (A & HB Company Limited, Tokyo, Japan), has now been manufactured and received medical approval from the Pharmaceuticals and Medical Devices Agency in Japan. We conducted a retrospective observational study of ED patients who used Vigor 2020 in clinical practice. Methods We analyzed male ED patients aged ≥20 years treated with Vigor 2020 in our outpatient clinics. The primary endpoint was improvement of erection as evaluated by an Erection Hardness Score (EHS) of ≥1 point. Secondary endpoints were improvement of sexual function and adverse events as evaluated by the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ‐EjD). Results Thirty‐three patients (mean age, 57.21 27–86 years) could be evaluated before and after using Vigor 2020. Among the 16 patients with baseline EHS ≤2, 14 (93.33%) improved by ≥1 point, and 10 of these 16 patients (62.50%) improved to EHS ≥3 and could insert vaginally. Significant improvement was observed for IIEF total score and for the MSHQ‐EjD in patients with an EHS of ≥3 after use of Vigor 2020. No patient experienced significant adverse events. Conclusions The Vigor 2020 may be an efficacious treatment tool for ED. Patients with significant ED experienced not only significant improvement of erection but also improvement of ejaculation with its use.
Shirai et al. (Tue,) studied this question.