Extracorporeal shockwave therapy in the treatment of erectile dysfunction: A prospective, randomized, double‐blinded, placebo controlled study

To investigate the role of low‐intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction.

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.

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).

The present trial shows the tolerability and clinical efficacy of low‐intensity extracorporeal shockwave therapy in a subgroup of patients with erectile dysfunction.