Abstract Introduction Erectile dysfunction (ED) is a prevalent condition that significantly impairs male health and quality of life, with incidence rising alongside aging and chronic comorbidities. While phosphodiesterase type-5 inhibitors remain the first-line therapy, a considerable subset of patients shows suboptimal response. Low-intensity extracorporeal shockwave therapy (LI-ESWT) has emerged as a promising alternative, yet the clinical predictors of treatment success remain insufficiently defined. Objective The objective of this study was to identify demographic and clinical factors that predict favorable response to LI-ESWT and to evaluate treatment outcomes based on International Index of Erectile Function (IIEF) scores. Methods Between March 2024 and May 2025, a total of 38 patients diagnosed with mild-to-moderate erectile dysfunction (ED) were prospectively enrolled. Inclusion criteria were baseline International Index of Erectile Function (IIEF-5) erectile function domain scores between 11 and 25. Exclusion criteria included prior pelvic surgery, malignancy, Peyronie’s disease, and chronic prostatitis. Demographic and clinical parameters including age, body mass index (BMI), smoking status, and comorbidity burden were systematically assessed using the Charlson Comorbidity Index. All patients completed baseline clinical evaluation, and follow-up assessments were performed 4 weeks after completion of treatment using the IIEF-5 questionnaire. Treatment response was defined as ≥2-point increase in IIEF-5 for mild ED and ≥5-point increase for moderate ED. The intervention consisted of six weekly sessions (once per week) of low-intensity focused extracorporeal shockwave therapy (LI-ESWT), delivered with an electro-pneumatic shockwave generator (Dornier, Germany). Each session involved 1600 shockwaves at 0.9 bar pressure and 3 Hz frequency. Results A total of 38 patients with mild-to-moderate erectile dysfunction were included, with a mean age of 53 years (range: 28–69). Following LI-ESWT, 17 patients (44%) achieved a clinically meaningful response, while 21 patients (56%) showed no significant improvement. Responders were significantly younger compared to non-responders (mean age 49.8 vs. 56.8 years, p=0.022). Baseline IIEF-5 erectile function domain scores in responders improved from 15.1 ± 4.4 to 21.3 ± 3.4 post-treatment (p=0.003). In contrast, non-responders demonstrated no significant change (17.9 ± 4.7 to 17.3 ± 4.3). Comorbidity burden was a strong predictor of treatment success. Among responders, 88% had a Charlson Comorbidity Index of 0, while none of the patients with a score of 2 achieved clinical benefit (p=0.002). Smoking appeared more prevalent among non-responders (72% vs. 52%), although this trend did not reach statistical significance (p=0.133). Conclusions This prospective study shows that low-intensity extracorporeal shockwave therapy (LI-ESWT) can provide meaningful improvements in erectile function for selected men with mild-to-moderate ED. Treatment response was significantly associated with younger age and lower comorbidity burden, while advanced age and higher Charlson Comorbidity Index scores predicted poor outcomes. Although smoking was more frequent among non-responders, this trend did not reach statistical significance, suggesting further investigation is warranted. Overall, careful patient selection is essential to maximize ESWT effectiveness, with younger patients without major comorbidities representing the most suitable candidates for this non-invasive therapeutic option in erectile dysfunction management. Disclosure No
Ahmadzada et al. (Mon,) studied this question.