Anıl H. et al., 2026: 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.

Anıl H, Yıldız A, Topuz AN, Kayra MV, Sözütok S, Altunkol A, Alma E, Topuz M, Bayazıt Y.
Sex Med. 2026 May 4;14(3):qfag025. doi: 10.1093/sexmed/qfag025

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 treatment success were absence of DM (odds ratio [OR] = 2.67, P = .012), ED duration <36 months (OR = 2.23, P = .026), cIMT <0.8 mm (OR = 2.04, P = .042), prior PDE5i benefit (OR = 2.47, P = .016), FMD ≥5% (OR = 2.57, P = .012), age <65 years (OR = 2.28, P = .032), and presence of cardiovascular risk factors (OR = 2.23, P = .036). A scoring system incorporating these 7 variables achieved an area under the curve of 0.819 (95% confidence interval [CI] 0.762-0.877). Using a cut-off of 4.5 points, the sensitivity was 73% and the specificity was 77% (P < .001).

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.

Comment Jens Rassweiler

Objective

The study aimed to identify clinical and vascular predictors of response to Li-ESWT in men with vasculogenic erectile dysfunction and to develop a practical non-invasive scoring system to predict treatment success.

Study Design

The study included 219 men aged 18-80 years with vasculogenic ED between January 2024 and January 2025. All patients underwent Li-ESWT using an electrohydraulic energy generator and a focusing probe (Modus ESWT, Inceler Medical, Ankara/Turkey). The device settings were 0.09 mJ/mm2 and 3 Hz (=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.

At 6 months after Li-ESWT, treatment success was defined as either:

• Increase of ≥1 point in Erection Hardness Score, or
• Increase of ≥5 points in IIEF-5 erectile function score

Results

The overall treatment response rate was 66.2% (145 responders out of 219 patients).

Independent predictors of treatment success were:

Based on this the authors proposed  a scoring system creating a 7-point clinical score. Each favorable factor gives 1 point:

• Cardiovascular risk factors present
• Age <65 years
• FMD ≥5%
• Previous PDE5 inhibitor benefit
• cIMT <0.8 mm
• No diabetes mellitus
• ED duration <36 months

Total score ranges from 0 to 7.

The optimal cut-off was 4.5 points, meaning patients scoring 5 or more were considered more likely to respond.

Predictive performance

The score performed fairly well with an AUC of 0.819, Sensitivity of 73%, Specificity of 77%, Positive predictive value of 0.86, Negative predictive value of 0.59, and an Overall accuracy of 74% suggesting the score is better at identifying likely responders than confidently excluding non-responders.

Clinical significance

The study suggests that Li-ESWT may be most beneficial in men with:

• Mild-to-moderate vasculogenic ED
• Shorter ED duration
• Preserved endothelial function
• Less systemic atherosclerotic burden
• Prior benefit from PDE5 inhibitors
• No diabetes
• Age under 65

The score could help clinicians decide which patients are more likely to benefit from Li-ESWT and avoid offering an expensive or time-consuming intervention to patients with a low predicted probability of response.

Discussion

Strengths of the study

This includes the prospective design, the relatively large sample size for a Li-ESWT study, the use of vascular markers: FMD and carotid intima-media thickness, the simple, clinically usable scoring system based on internal validation with bootstrapping resulting to an AUC of 0.819

Main limitations

- No randomized control or sham group: This is important because erectile dysfunction trials can have meaningful placebo effects.

- Single-arm design; Without a control group, it is difficult to determine how much improvement was truly caused by Li-ESWT.

- No external validation: The score was developed and internally tested in the same cohort. It needs testing in independent populations.

- Vasculogenic ED was clinically diagnosed: Penile Doppler ultrasound was not performed in all patients, so some patients may not have had objectively confirmed vasculogenic ED.

- The cardiovascular risk factor finding is counterintuitive: Presence of cardiovascular risk factors predicted better response, which is somewhat unexpected. This may reflect selection bias, disease stage differences, or confounding.

Conclusions

This study proposes a practical 7-point non-invasive scoring system to predict response to Li-ESWT in men with clinically diagnosed vasculogenic erectile dysfunction. The model showed good internal predictive performance, with an AUC of 0.819, but it requires external validation and ideally testing in randomized sham-controlled cohorts before routine clinical adoption.

Jens Rassweiler