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
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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