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Penile low intensity shock wave treatment for PDE5I refractory erectile dysfunction: a randomized double-blind sham-controlled clinical trial

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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.

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Author information

Authors and Affiliations

  1. Andrology Department, Fundació Puigvert/Universidad Autònoma de Barcelona, Carrer de Cartagena, 340-350, 08025, Barcelona, Spain

    Jose Vinay, Daniel Moreno, Osvaldo Rajmil, Eduard Ruiz-Castañe & Josvany Sanchez-Curbelo

  2. Urology Department, University of Chile Clinical Hospital, Santiago, Chile

    Jose Vinay

  3. Andrology Unit, Shady Grove Fertility, Santiago, Chile

    Jose Vinay

Authors
  1. Jose Vinay
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  2. Daniel Moreno
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  3. Osvaldo Rajmil
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  4. Eduard Ruiz-Castañe
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  5. Josvany Sanchez-Curbelo
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Contributions

JV: project development, data collection, data analysis, manuscript writing. DM: data collection. OR: project development. ER-C: project development. JS-C: project development, data collection, manuscript writing

Corresponding author

Correspondence to Jose Vinay.

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Conflicts of interest

The researchers received materials for the LI-EWST device from the manufacturer (Direx Group, Wiesbaden, Germany) to carry out the clinical trial. No special funding was received.

Research involving human participants and/or animals

This study was reviewed and approved by Fundació Puigvert Ethics Review Board: (FP-ANDRO-2016/01).

Informed consent

Participants provided written informed consent before enrolling in the study.

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Vinay, J., Moreno, D., Rajmil, O. et al. Penile low intensity shock wave treatment for PDE5I refractory erectile dysfunction: a randomized double-blind sham-controlled clinical trial. World J Urol 39, 2217–2222 (2021). https://doi.org/10.1007/s00345-020-03373-y

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  • DOI: https://doi.org/10.1007/s00345-020-03373-y

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