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

Abstract

<h3>Objectives</h3> 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 erectile dysfunction (ED). <h3>Methods</h3> 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. <h3>Results</h3> 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. <h3>Conclusions</h3> Combination of LiST twice weekly for three weeks and tadalafil 5mg once daily for four weeksmay 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 <h3>Conflicts of Interest</h3> Dimitrios Hatzichristou is a speaker and investigator for Dornier MedTech GmbH.