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Purpose:

We conducted the first double-blind, randomized, sham-controlled trial evaluating the efficacy and safety of low-intensity shock wave therapy (LiST) exclusively in patients with moderate erectile dysfunction.

Materials and Methods:

Seventy patients were randomized to 12 sessions of LiST (35) or sham therapy (35) twice weekly. Patients were evaluated at 1 and 3 months after completion of treatment. The proportion of participants attaining minimal clinically important difference (MCID) in the International Index of Erectile Function–Erectile Function (IIEF-EF) and the effect of LiST on erectile function, as well as on safety, were the study outcomes.

Results:

At 3 months, MCID was attained by 27 (79%) patients in the LiST group compared to 0 patients in the sham group. The risk difference between the 2 groups was 79%(95% confidence interval [CI]: 66–93, p< 0.001) and the baseline-adjusted mean between …