Initial experience with linear focused shockwave treatment for erectile dysfunction: a 6-month follow-up pilot study.

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.