Extracorporeal shockwave therapy in the treatment of erectile dysfunction: a prospective, randomized, double-blinded, placebo controlled study.

OBJECTIVES To investigate the role of low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction. METHODS This was a double-blinded, single-center, prospective, randomized, placebo-controlled trial. After a 2-week phosphodiesterase type 5 inhibitor washout period, patients were assessed with Sexual Health Inventory for Men, International Index of Erectile Function-ED domain scores and Erection Hardness Score. Randomization into either the low-intensity extracorporeal shockwave therapy group or the sham group took place. After the 9-week treatment period, patients were followed up 4 weeks later. Follow-up assessment was in the form of International Index of Erectile Function-ED domain score and Erection Hardness Score. RESULTS A total of 70 patients were recruited into the study, 58 patients completed the study. A total of 28 patients were randomized into the sham therapy arm, and 30 patients were randomized into the low-intensity extracorporeal shockwave therapy arm. There was no significant difference between these two groups in baseline International Index of Erectile Function-ED domain score and Erection Hardness Score. The mean International Index of Erectile Function-ED domain score of the low-intensity extracorporeal shockwave therapy arm and sham arm in week 13 were 17.8 ± 4.8 and 15.8 ± 6.1, respectively (P = 0.156). The mean Erection Hardness Scores in week 13 were 2.7 ± 0.5 and 2.4 ± 0.9, respectively (P = 0.163). When patients were stratified into different baseline Sexual Health Inventory for Men subgroups, the pre-intervention and post-intervention difference in low-intensity extracorporeal shockwave therapy was found to be significant in the subgroup with severe erectile dysfunction (low-intensity extracorporeal shockwave therapy International Index of Erectile Function-ED domain improvement: 10.1 ± 4.1 vs sham therapy International Index of Erectile Function-ED domain improvement: 3.2 ± 3.3; P = 0.003). CONCLUSION The present trial shows the tolerability and clinical efficacy of low-intensity extracorporeal shockwave therapy in a subgroup of patients with erectile dysfunction.