Efficacy and safety of low-intensity shockwave therapy plus tadalafil 5 mg once daily in men with type 2 diabetes mellitus and erectile dysfunction: a matched-pair comparison study

Low-intensity extracorporeal shockwave therapy (LiESWT) represents a promising treatment for patients with erectile dysfunction (ED). We investigated the efficacy of LiESWT combined with tadalafil 5 mg once daily in men with type 2 diabetes mellitus (T2DM) and ED and compared LiESWT protocols administering different number of shockwaves. We performed a retrospective matched-pair comparison using data from a prospectively maintained database. Seventy-eight patients who received tadalafil 5 mg once daily for 12 weeks + LiESWT performed with an electrohydraulic source for 3 weeks (Group A) were matched 1:1 to patients who received tadalafil 5 mg once daily alone for 12 weeks (Group B). A subgroup analysis was performed according to the number of shockwaves delivered during each session (1500, 1800, and 2400 in subgroup A1, A2, and A3, respectively). The mean International Index of Erectile Function-5 (IIEF-5) score variations with respect to baseline recorded at 4, 12, and 24 weeks after the end of the treatment were investigated as treatment outcomes. The mean IIEF-5 scores significantly improved in all groups and subgroups at 4-week follow-up without intergroup differences. At 12- and 24-week follow-up, the mean IIEF-5 improvement was significantly higher among patients in the A3 subgroup (+5.0 ± 2.1 [P < 0.001] and +4.7 ± 2.3 [P < 0.001], respectively). The combined approach with tadalafil 5 mg once daily and LiESWT with a protocol involving 2400 shockwaves provides significant advantages in terms of IIEF-5 improvement and durability compared to tadalafil 5 mg once daily alone in patients with T2DM and ED.