Low-Intensity Shockwave Therapy Improves Hemodynamic Parameters in Patients With Vasculogenic Erectile Dysfunction: A Triplex Ultrasonography-Based Sham-Controlled Trial

Background: Although several reports have documented the subjective improvement of erectile function after low-intensity extracorporeal shockwave therapy (LI-ESWT) in patients with vasculogenic erectile dysfunction (ED), objective assessment data of penile hemodynamics are lacking. Aim: To assess penile hemodynamics before and 3 months after LI-ESWT in a group of patients with documented vasculogenic ED. Methods: This was a double-blinded, randomized, sham-controlled trial. Forty-six patients with ED were randomized; 30 underwent LI-ESWT and 16 had a sham procedure in double-blinded fashion. All patients underwent penile triplex ultrasonography by the same investigator immediately before and 3 months after treatment. Patient demographics, International Index of Erectile Function erectile function domain (IIEF-ED) score, and minimal clinically important difference were assessed at baseline and 1, 3, 6, 9, and 12 months after treatment. Outcomes: Changes in peak systolic velocity and resistance index as measured by triplex ultrasonography at baseline and 3 months after treatment were the main outcomes of the study. Secondary outcomes were changes in the IIEF-EF score from baseline to 1, 3, 6, 9, and 12 months after treatment and the percentage of patients reaching a minimal clinically important difference during the same period for the two groups. Results: IIEF-EF minimal clinically important differences for the active vs sham group were observed for 56.7% vs 12.5% (P=.005) at 1 month, 56.7% vs 12.5% (P=.003) at 3 months, 63.3% vs 18.8% (P=.006) at 6 months, 66.7% vs 31.3% (P=.022) at 9 months, and 75% vs 25% (P=.008) at 12 months. Mean peak systolic velocity increased by 4.5 and 0.6 cm/s in the LI-ESWT and sham groups, respectively (P<.001). Clinical Implications: Such results offer objective and subjective documentation of the value of this novel treatment modality for men with vasculogenic ED. Strengths and Limitations: Strengths include the prospective, randomized, sham-controlled type of study and the assessment of penile hemodynamics. Limitations include the small sample and strict inclusion criteria that do not reflect everyday clinical practice. Conclusion: The present study confirms the beneficial effect of LI-ESWT on penile hemodynamics and the beneficial effect of this treatment up to 12 months. Copyright (C) 2017, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.