Abstract Introduction Erectile dysfunction (ED) is a highly prevalent condition, with phosphodiesterase type 5 inhibitors (PDE-5i) representing the most common first-line oral treatment. In recent years, Extracorporeal shockwave therapy (ESWT) has emerged as a promising non-pharmacological, potentially restorative treatment modality for ED. This has led to clinical interest in whether combining the restorative potential of ESWT with the symptomatic efficacy of PDE-5i offers a synergistic benefit over standard monotherapy. Objective This study aims to conduct a systematic review and meta-analysis to evaluate the synergistic effect of combining ESWT with PDE-5i compared to PDE-5i monotherapy. Methods We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing the efficacy of combined ESWT and PDE-5i therapy against PDE-5i monotherapy for patients with ED. The primary outcome was the mean difference (MD) in the International Index of Erectile Function-5 (IIEF-5) score at 1-month follow-up. Data were pooled using a fixed-effect model, and heterogeneity was assessed using the I2 statistic. Results Two RCTs (Setiawan et al. 2022 and Sönmez et al. 2017) were included in the meta-analysis. For the IIEF-5 score, the pooled analysis (N=49) demonstrated no statistically significant difference between the combination (ESWT + PDE-5i) and monotherapy (PDE-5i) groups at the 1-month follow-up (MD: 1.86; 95% CI -1.93, 5.65; p=0.34). This analysis showed no heterogeneity (I2=0%). Conclusions At 1-month follow-up, this meta-analysis found no statistically significant evidence that adding ESWT to PDE-5i therapy provides superior improvement in erectile function compared to PDE-5i monotherapy. The conclusion is limited by the small number of included studies, and further large-scale RCTs with longer-term follow-up are warranted to confirm these findings. Disclosure No
Mohamed et al. (Mon,) studied this question.