title: Extracorporeal shockwave therapy in the treatment of erectile dysfunction: a prospective, randomized, double-blinded, placebo controlled study.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  The present trial shows the tolerability and clinical efficacy of low-intensity extracorporeal shockwave therapy in a subgroup of patients with erectile dysfunction.
authors.affiliation: Division of Urology, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China.
authors.forename: Chi-Hang
authors.initials: CH
authors.lastname: Yee
authors.forename: Eddie Sy
authors.initials: ES
authors.lastname: Chan
authors.forename: Simon See-Ming
authors.initials: SS
authors.lastname: Hou
authors.forename: Chi-Fai
authors.initials: CF
authors.lastname: Ng
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000628:therapy*; D019220:High-Energy Shock Waves / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010410:Penile Erection; D011446:Prospective Studies; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
keywords: andrology; erectile dysfunction; randomized controlled trial; shockwave therapy