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Can low intensity shockwave therapy match the efficacy of phosphodiesterase-5 inhibitors for erectile dysfunction treatment? A pooled data analysis from two randomized clinical trials

International Journal of Impotence Research volume 33, pages 383–385 (2021)Cite this article

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Low intensity shockwave therapy (LiST) has been recently proposed as an emerging and very promising treatment option for erectile dysfunction (ED) [1]. Oral phosphodiesterase-5 inhibitors (PDE5Is) revolutionized sexual medicine field in the late 1990s and since then remain, indisputably, the most effective first-line ED monotherapy. Nevertheless, despite their excellent safety profile and treatment results, PDE5Is use have still several limitations including 23.9–57% voluntary discontinuation rate up to a 3-year usage period, 5–16.4% non-tolerable side effects and certain contraindications [2,3,4]. Furthermore, 42.3% of ED patients will not-respond to sildenafil monotherapy [4]. Data regarding efficacy comparison of these two ED treatment options are lacking. Aim of this study is to compare the efficacy of LiST sessions for ED treatment to the pre-LiST response of the same ED patients to PDE5Is treatment and also to investigate a potential additive efficacy result of increasing LiST sessions number.

Data were collected from two, already published, randomized clinical trials and a pooled analysis was performed [1, 5]. These studies followed the same design and an identical application technique by the same researchers, using the same shockwave machine (ARIES 2—Smart focus probe, Dornier MedTech GmbH, Wessling, Germany), was used. Study design, method of energy application, inclusion and exclusion criteria have been previously published [4, 5]. Patients receiving 6 (Group A, n = 21), 12 (6 + 6 or 12) (Group B, n = 84), or 18 (12 + 6) (Group C, n = 18) LiST sessions, with 5000 shockwaves/session and an energy flux density (EFD) of 0.05 mJ/mm2 were selected and included in this analysis. All patients had diagnosis of vasculogenic ED and were regular PDE5i users/responders. At screening, efficacy under the maximum tolerated dose of their favorite PDE5i was assessed by International Index for Erectile Function-Erectile Function domain (IIEF-EF). After 1 month wash out period, patients underwent LiST sessions. IIEF-EF score was also used to assess LiST efficacy. Change of IIEF-EF score from baseline to 1, 3, and 6 months follow-up (FU) visits was compared between the three groups and analyzed by repeated measures one-way ANOVA. Tukey’s multiple comparison test was also performed. IIEF-EF score under PDE5Is treatment vs IIEF-EF score at 6 months post-LiST was compared using two-tailed paired t-test. The level of significance was set at 5% (p < 0.05).

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Fig. 1: Results of the pooled data analysis.

References

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Authors and Affiliations

  1. 1st Department of Urology, Aristotle University of Thessaloniki, Thessaloniki, Greece

    Ioannis Mykoniatis, Dimitrios Kalyvianakis, Paraskevi Kapoteli, Filimon Zilotis, Agrippina Fournaraki, Evangelos Poulios & Dimitrios Hatzichristou

  2. Institute for the Study of Urological Diseases, Thessaloniki, Greece

    Paraskevi Kapoteli, Filimon Zilotis, Agrippina Fournaraki, Evangelos Poulios & Dimitrios Hatzichristou

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  1. Ioannis Mykoniatis
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  2. Dimitrios Kalyvianakis
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  3. Paraskevi Kapoteli
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  4. Filimon Zilotis
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  7. Dimitrios Hatzichristou
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Correspondence to Ioannis Mykoniatis.

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Mykoniatis, I., Kalyvianakis, D., Kapoteli, P. et al. Can low intensity shockwave therapy match the efficacy of phosphodiesterase-5 inhibitors for erectile dysfunction treatment? A pooled data analysis from two randomized clinical trials. Int J Impot Res 33, 383–385 (2021). https://doi.org/10.1038/s41443-020-0258-0

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