Efficacy and safety of low-intensity pulsed ultrasound (LIPUS) combined with tadalafil in the treatment of severe erectile dysfunction: a retrospective cohort study.

Abstract

Background: Low-intensity pulsed ultrasound (LIPUS) is an effective and safe treatment for mild to moderate erectile dysfunction (ED). This study aimed to investigate the efficacy and safety of combining LIPUS with tadalafil in treating severe ED.

Methods: The data from 27 patients treated with LIPUS alone (group A) and 21 patients treated with a combination of LIPUS and daily 10 mg tadalafil (group B) were retrospectively analyzed. The LIPUS regimen consisted of twice-weekly treatments for 4 consecutive weeks. The treatment was considered effective if the change in International Index of Erectile Function-Erectile Function Domain (IIEF-EF) score after treatment was greater than or equal to the minimal clinically important difference (MCID) (the MCID for severe ED is 7 points). The effectiveness, IIEF-EF score, erectile hardness score (EHS), peak systolic velocity (PSV), end diastolic velocity (EDV), and adverse events were evaluated before treatment, 4 weeks after treatment, and 12 weeks after treatment.

Results: Compared to pre-treatment, both groups showed significant improvement in IIEF-EF score and EHS at 4 and 12 weeks after treatment (P<0.001), with no statistically significant difference between the two time points (P>0.05). The effective rate did not significantly differ between group A (9/27, 33.3%) and group B (10/21, 47.62%) at 4 weeks or between group A (9/27, 33.3%) and group B (12/21, 57.14%) at 12 weeks after treatment (P=0.32, P=0.10). However, in patients without comorbidities, the effective rate of group B (12/18, 66.67%) was higher than that of group A (9/25, 36.00%) at 12 weeks after treatment (P=0.047). After LIPUS treatment, the PSV level significantly increased and the EDV level significantly decreased compared with before treatment (P<0.05). No adverse events were reported.

Conclusions: The study suggests that LIPUS has a therapeutic effect on severe ED patients, especially those without comorbidities. It may have a synergistic or overlapping effect with phosphodiesterase type 5 inhibitors (PDE5Is) on severe ED patients without comorbidities.