(281) Low-Intensity Shockwave Therapy Combined with Tadalafil 5mg Daily has Better Efficacy for Mild and Moderate Erectile Dysfunction: The Preliminary Results of a Multicenter Clinical Study in China

Introduction Most clinical studies have demonstrated that low-intensity extracorporeal shockwave therapy (Li-ESWT) can improved erectile function in patients with erectile dysfunction (ED). The EAU guideline recommended to use Li-ESWT for mild vasculogenic ED patients. However, the therapeutic advantages of Li-ESWT combined with phosphodiesterase type 5 inhibitors (PDE5i) have not been explored clearly in clinical practice for mild and moderate ED patients. Objective To compare the therapeutic effects of Li-ESWT and Li-ESWT combined with PDE5i in mild and moderate ED patients with 8≤IIEF-5≤16 from a multicenter clinical study in China. Methods Patients with ED which IIEF-5 score is less than 22 and aged 18–60 years old were enrolled from three clinical centers from Jun. 2019 to Mar. 2023. The demographic data, International Index of Erectile Function-5 (IIEF-5), erectile hardness score (EHS) and self-reported symptom questions were collected. Patients were treated by a linear low-energy shock waves generator (Renova). Low-intensity shock wave (energy density of 0.09mJ/mm2) treatments were applied (once a week, 4 weeks in total, 5000 shocks each time). Patients in Li-ESWT combined with PDE5i group took 5mg of tadalafil once a day for one continuous month during ESWT. Comparative analyses of pre- and post-treatment and intergroup were used for statistics. Results In total, 42 ED cases (37.43±11.86 years) in Li-ESWT group and 116 cases (37.41±10.14 years) in combined group were enrolled for analysis. The IIEF-5 score and EHS in both groups were significantly improved after 1 month treatment (p<0.01). Compared with Li-ESWT group, patients in combined group significantly had higher self-reported efficiency (61.2% vs. 47.6%, p=0.013), IIEF-5 scores (15.34±7.15 vs. 13.96±7.71, p=0.039) and EHS (2.85±0.82 vs. 2.69±0.89, p=0.050). In the mild and moderate ED (with 8≤IIEF-5≤16) sub-group, 30 ED cases (36.81±10.99 years) in Li-ESWT group and 96 cases (36.80±10.69 years) in combined group were enrolled for analysis. The combined regimen showed better therapeutic advantages, including effective parameters IIEF-5(14.50±6.74 vs. 12.87±8.54, p=0.040), EHS (2.85±0.75 vs. 2.81±0.67, p=0.046) and self-reported efficiency (64.2% vs. 54.1%, p=0.001). Conclusions Li-ESWT can effectively improve erectile function in this multicenter clinical study in China, and the combination of Li-ESWT with daily use PDE5i had a better therapeutic effect on Chinese ED patients, especially on mild and moderate ED. Long-term follow-up with large sample study need to be developed for exploring the optimal therapeutic regimen. Disclosure No.