Presentation Authors: Jose Vinay*, Daniel Moreno, Osvaldo Rajmil, Eduardo Ruiz-Castañe, Josvany Sanchez-Curbelo, Barcelona, Spain
Introduction: Erectile dysfunction (ED) is a prevalent condition in males, affecting around 52% of men over 40 years. In recent years, the use of penile low intensity shockwave treatment (LI-ESWT) has been studied on vascular ED patients, because of its potential role in modifying several pathways of ED pathophysiology. The theoretical effect of LI-ESWT is based on its ability to increase the blood supply of treated areas. The objective of this trial is to investigate the effect of electromagnetic LI-ESWT on the erectile function of patients suffering phosphodiesterase type 5 inhibitor (PDE5i) refractory vascular ED
Methods: Randomized, simple-blind, sham-controlled study. 76 patients with PDE5i-refractory ED completed the study. 40 men were treated with linear electromagnetic penile LI-ESWT (1 session/ week for 4 weeks, 5000 shocks/session, using 0.09 mJ/mm2 of energy density) and 36 were treated with a sham probe. Baseline and post-treatment (1, 3 and 6 months) evaluations were done using validated erectile function questionnaires (IIEF-EF, EHS, SEP2, SEP3 and GAQ1). The groups were compared using Mann-Whitney-Wilcoxon and chi-squared tests, with results considered statistically significant at p < 0.05
Results: At baseline, active and sham groups were similar regarding age, erectile function and comorbidity load. Both groups had moderate ED, with a median IIEF-EF of 12 (IQR 8-17) in the treated group and 13 (IQR 8-17) in the sham group (p=0.352). Three months after treatment, changes in median IIEF-EF scores for active and sham groups were 3.5 (IQR 0-10) and -0.5 (IQR 8-17), respectively (p < 0.05). Six months after treatment, 21 patients (52.5%) in the active group and 10 patients (27.8%) in the sham group presented a EHS>2 (p < 0.05). At the same evaluation, 16 (40.0%) and 5 patients (13.9%) had positive answers to the GAQ-1 question (p < 0.05), in the treated and sham groups, respectively. No adverse events were observed during treatment or follow-up
Conclusions: Several studies have hypothesized that shockwaves could improve cavernous tissue blood supply through neo-angiogenesis, recruitment of progenitor cells, modulation of vasodilation and nerve regeneration. In this study, linear electromagnetic LIS-ESWT improved different erectile function parameters at 3 and 6 months of follow-up, when used on refractory ED patients. Only one previous group carried out a randomized clinical trial with patients presenting refractory ED, obtaining similar results to the current study with shorter follow up and smaller sample size.