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.

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 treatment success were absence of DM (odds ratio [OR] = 2.67, Clinical Implications: This scoring system may help clinicians identify patients most likely to benefit from Li-ESWT, optimize patient selection, and improve individualized treatment strategies in vasculogenic ED. Strengths & Limitations: The study is strengthened by its prospective design, relatively large sample size, and inclusion of vascular function parameters (FMD, cIMT). Limitations include the lack of external validation and the absence of penile Doppler ultrasound confirmation in all patients. Conclusion: This study identified key demographic and vascular predictors of Li-ESWT response and introduces a novel, non-invasive clinical scoring system with strong predictive accuracy. This tool may enhance treatment personalization and support clinical decision-making in the management of ED.