Low-intensity shockwave therapy (LiST) for erectile dysfunction: a randomized clinical trial assessing the impact of energy flux density (EFD) and frequency of sessions

The impact of energy flux density (EFD) used on low-intensity shockwave therapy (LiST) for erectile dysfunction (ED) has not been explored. Our aim was to compare EFD 0.05 versus 0.10 mJ/mm 2 regarding efficacy and safety of 12-treatment sessions when applied two or three times per week. Ninety-seven patients with vasculogenic ED, PDE5 inhibitors users were randomized into four groups, to receive 12 LiST sessions. Group A ( n = 24) : two sessions per week, EFD 0.05 mJ/mm 2 ; Group B ( n = 24): three sessions per week, EFD 0.05 mJ/mm 2 ; Group C ( n = 24): two sessions per week, EFD 0.10 mJ/mm 2 ; Group D ( n = 25): three sessions per week, EFD 0.10 mJ/mm 2 . International Index for Erectile Function—Erectile Function domain (IIEF-EF), Minimally clinical important differences (MCID), sexual encounter profile, and triplex ultrasonography parameters were used to asses erectile function. Eighty-nine patients completed the 6-month follow-up (FU). All four groups improved in mean IIEF-EF score, average SEP3 “Yes” response rates at 6-month FU visit compared with baseline ( p