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Objectives

To conduct the first double-blind, randomized, sham-controlled trial evaluating the efficacy and safety of low-intensity shockwave therapy (LiST) in patients with moderate vasculogenic erectile dysfunction (ED) and previous good or partial response to phosphodiesterase-type 5 inhibitors.

Methods

Seventy patients fulfilling the eligibility criteria were randomized to twelve sessions of LiST (n=35) or sham therapy (n=35) twice weekly. Patients were evaluated at one and three months after completion of treatment. The study outcomes were the proportion of participants attaining minimal clinically important difference (MCID) in the International Index of Erectile Function–Erectile Function (IIEF-EF), the effect of LiST on the IIEF-EF and Sexual Encounter Profile (SEP) diaries, as well as on safety.

Results

At three 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 two groups was 79% [95% confidence interval (CI): 65.8-93, p<0.001] and the baseline-adjusted mean between-group-difference in the IIEF-EF was 4.4 points (95%CI: 3.4-5.4, p<0.001). At one month, MCID was attained by 20 (58.8%) patients in the LiST group compared to 1 (2.9%) patient in the sham group. The risk difference between the two groups was 55.9% (95%CI: 38.4-73.4, p<0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 3.9 points (95%CI: 2.7-5.2, p<0.001). Similarly, the proportion of “yes” responses to question 3 of SEP diaries also presented a statistically significant improvement after LiST compared to sham therapy.

Issue Section:
B-03-04 > #127
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