P-01-046 Low intensity extracorporeal shock wave therapy in patients with vasculogenic erectile dysfunction: A placebo-controlled cross-over study in oral PDE5i non-responders

Low-intensity extracorporeal shock wave therapy (Li-ESWT) shows encouraging results in patients with vasculogenic erectile dysfunction (ED). This single-arm cross-over study investigated Li-ESWT efficacy in ED patients who were non-responders to oral phosphodiesterase type 5 inhibitors (PDE5i), with each patient serving as his own sham control. The Dornier Aries device was used on ED patients with multiple cardiovascular risk factors, IIEF-ED score ≤ 15, and who were non-responsive to oral PDE5i. After 1-month washout without oral PDE5i, patients received 5 once-a-week sessions with a sham applicator. After 1-week break, they received 5 once-a-week sessions with an active applicator. During active treatment, a total of 5000 shockwaves (energy flux density 0.051 mJ/mm2) were applied at the penile shaft and crus. Patients were not informed that the first 5 sessions were with a sham. IIEF-ED and penile hemodynamics were assessed at baseline, after sham treatment, and 1 and 3 months after active treatment. Patients were allowed to resume oral PDE5i after the 1-month follow-up (FU) assessment.