Low-intensity shockwaves (LISW) are known to produce revascularization and have been in evaluation and in use to treat erectile dysfunction (ED). The present single-arm pilot study is aimed to assess the safety and efficacy of a dedicated shockwave device (Renova) on vasculogenic ED patients. Fifty-eight patients with mild to severe ED were treated by LISW and their erectile function was evaluated by the International Index of Erectile Function–Erectile Function Domain (IIEF–EF), Sexual Encounter Profile and Global Assessment Questions questionnaires, at baseline and at 1, 3 and 6 months post treatment. The average IIEF–EF increased significantly from 14.78 at baseline to 21.93 at 3 months post treatment and stabilized at 22.26 at 6 months post treatment. Out of 58 patients, 47 (81%) had a successful treatment. No adverse events were reported during the treatment and the follow-up duration. In conclusion, it suggests that the performance of LISW could add a new advanced treatment for ED.

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