Shock Wave Therapy in the Treatment of Erection Dysfunction: How to Define Clinical Outcomes? A Comparison Between Penile Doppler Ultrasound and a New Visual Erec-tion Hardness Score (V-EHS) During a Blinded, Sham-Controlled Trial.

Background: In the last decade, several studies have proven the effectiveness of low-intensity shock waves (LI-ESWT), but with several factors that make it difficult to carry out systematic reviews.

Aim: To demonstrate the effectiveness of LI-ESWT and define the best tool for routine clinical assessment of erectile dysfunction.

Materials and methods: Twenty-one participants with purely vasculogenic erectile dysfunction were selected and randomized to LI-ESWT or placebo. All patients underwent evaluation with The International Index of Erectile Function (IIEF-5), V-EHS (new visual scale), and standardized penile doppler ultrasound before and after shock wave therapy.

Outcomes: LI-ESWT has proven effective in the treatment of moderate erectile dysfunction, and the new V-EHS has demonstrated greater accuracy than Doppler in the diagnosis and follow-up of erectile dysfunction.

Results: Using the IIEF-5 as a control tool, we observed a clinical response after 1 month, with a greater increase in the shock wave therapy arm of +3.21 points compared to + 0.57 in the sham group. At six months, the treated group showed a mean increase of 4.71 points compared to baseline (p = 0.006), while those who received sham therapy had a decrease (case = +4.71 points vs. sham control = -1.0, p = 0.006). Based on this observed difference, we performed a comparative analysis between the V-EHS and penile doppler ultrasound to observe whether the test results corroborated the IIEF-5 findings. The correlation between V-EHS and IIEF-5 in the therapy group in the pre-therapy period was strong (r = 0.816, p < 0.001), and at 6 months it increased to very strong (r = 0.928, p < 0.001). Penile Doppler ultrasound did not show the same correlation strength with IIEF-5, presenting a moderate correlation at 6 months (Pearson correlation score = 0.540), as also demonstrated in the ROC curve through the V-EHS AUC = 0.963 (p = 0.001) vs. Doppler AUC = 0.713 (p = 0,290). Strengths and Limitations: The main strengths of the present study are the blinded, randomized, placebo-controlled clinical trial and the comparison between penile Doppler and a new visual classification for erection hardness score. The limitations are the number of patients and the short follow-up.

Conclusions: LI-ESWT has proven effective in the treatment of moderate vasculogenic erectile dysfunction, with optimal results at 6 months. The new V-EHS offers a simple, reliable and reproducible assessment of erectile function.