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Vinay J. et al., 2020: Penile low intensity shock wave treatment for PDE5I refractory erectile dysfunction: a randomized double-blind sham-controlled clinical trial

Vinay J, Moreno D, Rajmil O, Ruiz-Castañe E, Sanchez-Curbelo J.
Andrology Department, Fundació Puigvert/Universidad Autònoma de Barcelona, Carrer de Cartagena, 340-350, 08025, Barcelona, Spain.
Urology Department, University of Chile Clinical Hospital, Santiago, Chile.
Andrology Unit, Shady Grove Fertility, Santiago, Chile.
Andrology Department, Fundació Puigvert/Universidad Autònoma de Barcelona, Carrer de Cartagena, 340-350, 08025, Barcelona, Spain.

Abstract

Purpose: Over the last decade, penile low-intensity extracorporeal shockwave therapy (LI-ESWT) has emerged as a promising alternative for the treatment of erectile dysfunction (ED). The aim of this trial is to assess the effect of electromagnetic LI-ESWT on the erectile function of vascular phosphodiesterase type 5 inhibitor (PDE5I) refractory ED patients.

Methods: Randomized, double-blind, sham-controlled study. 76 patients with vascular PDE5I-refractory ED completed the study. 40 men were treated with LI-ESWT (1 session/week for 4 weeks, 5000 shocks/session, 0.09 mJ/mm2 energy density) and 36 were treated with a sham probe. Baseline and post-treatment (1, 3 and 6 months) evaluations were performed using validated erectile function questionnaires (IIEF-EF, EHS, SEP2, SEP3 and GAQ1). The groups were compared using Mann-Whitney-Wilcoxon and chi-squared tests, with results considered statistically significant at p < 0.05.

Results: At the 3-month follow-up, median change in IIEF-EF score for active and sham groups was 3.5 (IQR 0-10) and - 0.5 (IQR - 11 to 1), respectively (p < 0.05). Six months after treatment, 52.5% of patients (21/40) in the active group and 27.8% of patients (10/36) in the sham group presented an EHS > 2 (p < 0.05). At the same evaluation, 40.0% (16/40) and 13.9% (5/36) of patients had positive answers to GAQ-1, in the treated and sham groups, respectively (p < 0.05). No adverse events were observed during the study.

Conclusion: This study showed that penile electromagnetic shockwave therapy may improve erectile function, to a modest extent, on certain patients that do not respond to PDE5I; making it an alternative for vascular ED patients that reject more invasive therapies.
World J Urol. 2020 Jul 21. doi: 10.1007/s00345-020-03373-y. Online ahead of print. PMID: 32696128

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Commentaires 1

Hans-Göran Tiselius le vendredi 22 janvier 2021 08:30

EAU recently carried out a survey among men and women on erectile dysfunction (ED) and came to the conclusion that there was an alarmingly low awareness of this problem. This is unfortunate inasmuch as 52% of men aged 40-70 had ED problems. There is a range of methods for improving erectile function, most popular is the use of PDE5I (phospho-di-esterase type 5 inhibitor). For men in whom this medication does not work the situation is more problematic and, as mentioned in the article, several available alternatives “take the spontaneity out of sex”.

This article is a report of a randomized double-blind sham-controlled trial in men with vasculogenic ED resistant to PDE5I. The conclusion was that Li-ESWT had a modest effect on the dysfunction.

The median IIEF-EF score was significantly increased in the Li-ESWT-group at 3 months. EHS>2 (erectile hardness score) was significantly increased after 6 months.

The patients in this series were treated with one session of Li-ESWT per week during four weeks. All treatments were carried out with the Direx device: 5000 shocks, 2Hz (0.09 mJ/mm2).

The results indicate that the clinical improvement comes late and it would indeed be interesting to see another study in which the treatment period is extended and follow-up much longer.

Hans-Göran Tiselius

EAU recently carried out a survey among men and women on erectile dysfunction (ED) and came to the conclusion that there was an alarmingly low awareness of this problem. This is unfortunate inasmuch as 52% of men aged 40-70 had ED problems. There is a range of methods for improving erectile function, most popular is the use of PDE5I (phospho-di-esterase type 5 inhibitor). For men in whom this medication does not work the situation is more problematic and, as mentioned in the article, several available alternatives “take the spontaneity out of sex”. This article is a report of a randomized double-blind sham-controlled trial in men with vasculogenic ED resistant to PDE5I. The conclusion was that Li-ESWT had a modest effect on the dysfunction. The median IIEF-EF score was significantly increased in the Li-ESWT-group at 3 months. EHS>2 (erectile hardness score) was significantly increased after 6 months. The patients in this series were treated with one session of Li-ESWT per week during four weeks. All treatments were carried out with the Direx device: 5000 shocks, 2Hz (0.09 mJ/mm2). The results indicate that the clinical improvement comes late and it would indeed be interesting to see another study in which the treatment period is extended and follow-up much longer. Hans-Göran Tiselius
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lundi 19 avril 2021

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