A Randomized, Single-Blinded Clinical Trial Evaluating the Effect of Extracorporeal Shockwave Treatment (ESWT) as Add-On Therapy to Vacuum Erectile Device on Peyronie's Disease

Purpose: The aim of this study was to investigate whether ESWT with a higher energy as an add-on therapy to vacuum-pump followed by manipulation exercises could reduce the penile curvature, pain and improve IIEF-5 score. Materials and Methods: Men aged >18 and <80 years and diagnosed with PD in stable phase with no history of penile surgery or previous ESWT treatment were eligible to participate. They were randomised to either active ESWT (n = 16) or sham ESWT (n = 16). Both groups were treated once a week for five weeks. Each treatment session consisted of 2000 shockwaves at 0.5mJ/mm(2). All patients in both groups used a vacuum pump followed by manipulation exercises. Results: Thirty men completed the study protocol. Mean age in the treatment group was 61.7 (SD 8.3) and 63 (SD 7.35) in the control group. After six months, mean change in penile curvature was -12.8 (SD 13) degrees in the treatment group and -6.6 (SD 8.9) in the control group (p = 0.204). Mean IIEF-5 score decreased by 0.17 (SD 3) in the treatment group and 3.06 (SD 5.5) in the control group (p = 0.086) at six-month follow-up. Pain was assessed using both VAS and PDQ and demonstrated no difference between the groups after six months (p = 0.648). Conclusion: In the treatment group, we observed a greater but non-significant change in penile curvature and no adverse effects.