INTRODUCTION: Previous studies have indicated that low-intensity extracorporeal shockwave therapy (Li-ESWT) may improve male erectile dysfunction (ED) of vascular aetiology. AIM: To investigate penile rehabilitation of Li-ESWT in a randomized, placebo-controlled trial in men with ED following robotic nerve-sparing radical prostatectomy (RARP). METHODS: Included were men with ED following nerve-sparing RP with a score <22 in the 5-item International Index of Erectile Function (IIEF-5) questionnaire. Participants were divided into an active A (n = 20) and a placebo/sham B group (n = 18). They were randomized consecutively upon study entry. Each study arm had one treatment a week for 5 weeks. MAIN OUTCOME MEASURES: Sexual outcomes were assessed by international validated questionnaires, Erection Hardness Score (EHS) and IIEF-5 at baseline and at 4 and 12 weeks after treatment. RESULTS:A total of 38 (n = 38) participants were enrolled; there were no dropouts. A significant increase was observed in IIEF-5 and EHS in group A at both 4 and 12 weeks. At 12 weeks, the mean IIEF-5 score had increased by 3.45 points (P = .026), while the mean EHS score had increased by 0.5 points (P= .019). CONCLUSION: This randomized study indicates that Li-ESWT for ED in men undergone RP might be effective and safe. However, further and more robust research is needed before Li-ESWT can be characterized as a reliable treatment modality. PBJ Ladegaard, J Mortensen, SM Skov-Jeppesen, et al. Erectile Dysfunction A Prospective Randomized Placebo-Controlled Study Evaluating the Effect of Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT) in Men With Erectile Dysfunction Following Radical Prostatectomy. J Sex Med 2021;XX:XXX-XXX.
RCT Entities:
INTRODUCTION: Previous studies have indicated that low-intensity extracorporeal shockwave therapy (Li-ESWT) may improve male erectile dysfunction (ED) of vascular aetiology. AIM: To investigate penile rehabilitation of Li-ESWT in a randomized, placebo-controlled trial in men with ED following robotic nerve-sparing radical prostatectomy (RARP). METHODS: Included were men with ED following nerve-sparing RP with a score <22 in the 5-item International Index of Erectile Function (IIEF-5) questionnaire. Participants were divided into an active A (n = 20) and a placebo/sham B group (n = 18). They were randomized consecutively upon study entry. Each study arm had one treatment a week for 5 weeks. MAIN OUTCOME MEASURES: Sexual outcomes were assessed by international validated questionnaires, Erection Hardness Score (EHS) and IIEF-5 at baseline and at 4 and 12 weeks after treatment. RESULTS: A total of 38 (n = 38) participants were enrolled; there were no dropouts. A significant increase was observed in IIEF-5 and EHS in group A at both 4 and 12 weeks. At 12 weeks, the mean IIEF-5 score had increased by 3.45 points (P = .026), while the mean EHS score had increased by 0.5 points (P= .019). CONCLUSION: This randomized study indicates that Li-ESWT for ED in men undergone RP might be effective and safe. However, further and more robust research is needed before Li-ESWT can be characterized as a reliable treatment modality. PBJ Ladegaard, J Mortensen, SM Skov-Jeppesen, et al. Erectile Dysfunction A Prospective Randomized Placebo-Controlled Study Evaluating the Effect of Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT) in Men With Erectile Dysfunction Following Radical Prostatectomy. J Sex Med 2021;XX:XXX-XXX.