Low-intensity Extracorporeal Shock Waves for Treatment of Erectile Dysfunction in Patients Not Responding to Phosphodiesterase Type 5 Inhibitors, Its Durability, and Factors That May Influence the Outcome: A Clinical Trial

Background: Non-invasive treatments, such as low-intensity extracorporeal shock waves treatment (Li-ESWT), can be a safe and effective alternative for patients with erectile dysfunction (ED) who are resistant to phosphodiesterase type 5 inhibitors (PDE5Is). Objectives: This clinical trial study aimed to evaluate the effect of Li-ESWT on ED in non-responders to PDE5Is, its durability, and factors predicting its success. Methods: This study was conducted on 128 patients with ED who were resistant to PDE5Is. Before any intervention, written informed consent was obtained, demographic characteristics were collected, and the severity of the ED score was determined using the international index of erectile function (IIEF). Patients were treated with Li-ESWT, and ED severity was remeasured by the IIEF scale at the end of the intervention, three months, and six months after the intervention. The data were analyzed by chi-square, repeated measure ANOVA, Bonferroni post hoc, and binary logistic regression tests. Results: A total of 128 patients with ED who had not responded to PDE5Is, with a mean age of 58.35 ± 8.28 and an average ED of 3.41 ± 1.78 years, were included. At the end of the intervention, the IIEF score significantly increased. Moreover, this score was significantly higher three months and six months after the intervention. Three and six months later, the IIEF score decreased significantly. However, the score was significantly higher all three times than before the intervention. Being younger than 60 years, having an ED duration of fewer than three years, being non-smoking, being non-diabetic, and having no lower urinary tract symptoms (LUTS) were the most prominent predictors of a successful ED treatment. Conclusions: Low-intensity extracorporeal shock waves treatment is a safe and effective method for short and long-term treatment of ED patients. Identifying predicting factors can be beneficial for urologists in selecting suitable patients and avoiding the overtreatment of those who are not suitable candidates.