Development of a clinical scoring system to predict response to low-intensity shock wave therapy in clinically diagnosed vasculogenic erectile dysfunction: a prospective, non-randomized, single-arm, interventional study
Abstract
Background: Erectile dysfunction (ED) is a prevalent condition, with vasculogenic ED being the most common subtype, primarily related to endothelial dysfunction and cardiovascular risk factors. Low-intensity extracorporeal shock wave therapy (Li-ESWT) has emerged as a promising non-invasive treatment option. However, predictors of treatment response remain poorly defined.
Aim: To identify clinical and vascular predictors of treatment success following Li-ESWT in patients with vasculogenic ED and to develop a novel, practical, and non-invasive scoring system to predict therapeutic response.
Methods: This prospective study included 219 men aged 18-80 years with vasculogenic ED between January 2024 and January 2025. All patients underwent Li-ESWT (18 000 pulses over 3 weeks). Clinical and vascular parameters, including age, ED duration, body mass index, presence of cardiovascular risk factors, diabetes mellitus (DM), carotid intima-media thickness (cIMT), flow-mediated dilation rate (FMD), and prior phosphodiesterase type 5 inhibitor (PDE5i) response, were recorded. Treatment success at 6 months was defined as an increase of ≥1 point in the erection hardness score or ≥5 points in the International Index of Erectile Function-5 EF.
Outcomes: The primary outcome was treatment success at 6 months after Li-ESWT. Secondary outcomes included the development and validation of a predictive scoring system.
Results: Treatment success rate was 66.2% (145/219). Independent predictors of…
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. Reported size: 219 participants or records.
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