Evaluation of clinical efficacy, safety and patient satisfaction rate after low-intensity extracorporeal shockwave therapy for the treatment of male erectile dysfunction: an Australian first open-label single-arm prospective clinical trial.

OBJECTIVE To evaluate the efficacy, safety and patient satisfaction rate with low-intensity extracorporeal shockwave therapy (LiESWT) in Australian men with erectile dysfunction (ED), as LiESWT induces neovascularisation and potentially enhances penile perfusion and improves erectile function. PATIENTS AND METHODS Open-label single-arm prospective study of patients with ED with five-item version of the International Index of Erectile Function (IIEF-5) scores of >12 at baseline were enrolled after informed consent. Patient demographics, change in IIEF-5 and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores, and overall satisfaction score (on a 5-point scale) were recorded. Treatment consists of 3000 shockwaves (1000 shockwaves to the distal penis, base of penis and corporal bodies at the perineum) twice weekly for 6 weeks. RESULTS All patients had tried and failed oral phosphodiesterase type 5 inhibitors and most of the patients hah had ED for >18 months [mean (range) 21.8 (6-60) months]. No side-effects to LiESWT were reported. Most patients reported an improvement in IIEF-5 score by 5 points (60%) and EDITS Index score by >50% (70%). Most patients were satisfied (scoring 4 out of 5; 67%) and would recommend the therapy to their friends (80%). CONCLUSION LiESWT appears to improve erectile function, is safe and potential plays an important role in penile rehabilitation in men whom failed medical therapy.