The effect of combination treatment with low-intensity shockwave therapy and Tadalafil on mild and mild-to-moderate erectile dysfunction: A double-blind, randomized, placebo-controlled clinical trial

Abstract

ABSTRACT Introduction Combination of different first-line treatments for erectile dysfunction (ED) has emerged as a promising therapeutic approach. Objectives To conduct the first double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of combination therapy with low-intensity shockwave therapy (LiST) and tadalafil versus LiST and placebo in patients with mild or mild-to-moderate vasculogenic ED. Methods Fifty sexually active patients fulfilling the eligibility criteria were randomly assigned to six sessions of LiST twice weekly for three weeks and tadalafil once daily (n=25) or placebo (n=25) for four weeks. Patients were evaluated at one, three and six months after completion of the treatment protocol. An intension-to-treat analysis was performed. Erectile function was assessed at all time points based on the International Index of Erectile Function – Erectile Domain (IIEF-EF) and the Sexual Encounter Profile (SEP) diaries. The number of patients attaining a minimal clinically important difference (MCID) in the IIEF-EF, as well as the safety of combination therapy were also evaluated. Results Adjusting for the baseline values, IIEF-EF improved by 0.8 points (95%CI: -0.2-1.9, p=0.12) at one month, 1 point (95%CI: 0.1-1.9, p=0.02) at three months and 1.7 (95%CI: 0.8-2.7, p =<0.001) at six months in patients treated with combination of LiST and tadalafil compared to LiST and placebo. Between the two groups, the proportion of “yes” responses to question 3 of SEP diaries improved significantly only at the 6-month evaluation, while the number of patients attaining a MCID in the IIEF-EF only at the 3-month evaluation. No adverse events were reported during the whole study period. Conclusions Combination of LiST twice weekly for three weeks and tadalafil 5mg once daily for four weeks may further ameliorate mild or mild-to-moderate vasculogenic ED compared to LiST monotherapy and is considered a safe treatment modality. Still, further high-quality studies are warranted to corroborate our findings. Disclosure Work supported by industry: no.