Abstract

Abstract Introduction Multiple treatment modalities have been used to treat erectile dysfunction (ED), including focal shock waves. This therapy has demonstrated a short-term positive effect in patients who respond or not to PDE-5i, with variability in therapeutic protocols. Aim To evaluate the effectiveness of 3 shock wave protocols for the treatment of ED. Methods Randomized, multicenter clinical trial. 277 men with non-psychological ED, over 18 years of age, without cancer or major surgeries in the pelvic area or any neurological disease that affected their erectile function, were randomized to one of three groups: weekly (6 wave sessions (WS), 1 x wk), monthly (6 WS 1 x month) or reinforcement (6 WS, 1 x week + 5 sessions, 1 x month). The wave parameters were the same in all groups, no patient received medication. The primary outcome was the change in IIEF-EF score at 6 months of follow-up. The change in the IIEF at the end of therapy and at 3 months of follow-up, erection hardness with the EHS, self-esteem with the SEAR questionnaire, and side effects were also evaluated. Results 222 patients completed the study. In the 6-month evaluation, the average change in the IIEF-EF in the monthly schedule was 4.3 (+/-6.7), 1.9 (+/-6.5) in the weekly schedule, and 5.0 (+/-6.1) in the reinforcement schedule ( p=0.0086). At the end of therapy and at 3 months the change in the IIEF-EF was 3.2 (+/-5.8) and 2.9 (+/-5.5) in the monthly group, 2.7 (+/-4.5) and 3.0 (+/-5.3) in the weekly one, and 4.2 (+/-6.4) and 4.4 (+/-6.5) in the reinforcement one. No differences were found between the groups in the proportion of patients who increased at least one point in erection hardness, nor in the average in the SEAR questionnaire in the evaluations carried out. No patient reported adverse effects to the therapy. Conclusions The results suggest that monthly and reinforcement wave schemes present good results for the treatment of ED. Financing Boston Medical Group.

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