Journal
JOURNAL OF SEXUAL MEDICINE
Volume 19, Issue 1, Pages 106-115Publisher
OXFORD UNIV PRESS
DOI: 10.1016/j.jsxm.2021.10.007
Keywords
Combination Therapy; Low-Intensity Shockwave Therapy; Tadalafil; Erectile Function; Erectile Dysfunction; Randomized Controlled Trial
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This study was the first double-blind, randomized, placebo-controlled clinical trial evaluating the efficacy and safety of combination therapy with low-intensity shockwave therapy (LiST) and tadalafil in patients with mild or mild-to-moderate vasculogenic ED. The results showed significant improvements in IIEF-EF scores at 1 month, 3 months, and 6 months in the combination therapy group, with a significant increase in the number of patients achieving clinical important difference at 3 months.
Background: Combination of different first-line treatments for erectile dysfunction (ED) has emerged as a promising therapeutic approach. Aim: 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 vs 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 6 sessions of LiST twice weekly for 3 weeks and tadalafil (n = 25) or placebo (n = 25) once daily for 4 weeks. Patients were evaluated at 1, 3, and 6 months after completion of the treatment protocol. Outcomes: The primary outcome was the mean change from baseline in the International Index of Erectile Function-Erectile Function (IIEF-EF) domain between the 2 groups at 3 months after treatment. Erectile function was also assessed at 1 and 6 months. The number of patients attaining a minimal clinically important difference (MCID) in the IIEF-EF, as well as the safety of combination therapy were evaluated. Results: Adjusting for the baseline values, IIEF-EF improved by 0.8 points more (95% confidence interval [CI] = -0.2 to 1.9, P = .12) at 1 month, 1 point more (95% CI = 0.1-1.9, P = .02) at 3 months and 1.7 points more (95% CI = 0.8-2.7, P < .001) at 6 months in patients treated with combination therapy compared to monotherapy. The number of patients attaining a MCID in the IIEF-EF between the 2 groups improved significantly only at the 3-month evaluation. No adverse events were reported during the whole study period. Clinical Implications: Combination of LiST twice weekly for 3 weeks and tadalafil 5 mg once daily for 4 weeks may further ameliorate mild or mild-to-moderate vasculogenic ED compared to LiST monotherapy. Strengths & Limitations: We conducted the first randomized trial exploring the role of LiST and tadalafil in the management of ED. Conversely, our study lacks external validity due to its single-center design. Conclusion: The addition of daily low-dose tadalafil during application of LiST may further improve erectile function compared to application of LiST as a standalone treatment in patients with mild or mild-to-moderate vasculogenic ED. Still, further high-quality studies are warranted to corroborate our findings. Copyright (C) 2021, International Society of Sexual Medicine. Published by Elsevier Inc. All rights reserved.
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