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Low intensity shockwave therapy in combination with phosphodiesterase-5 inhibitors is an effective and safe treatment option in patients with vasculogenic ED who are PDE5i non-responders: a multicenter single-arm clinical trial

International Journal of Impotence Research volume 33, pages 634–640 (2021)Cite this article

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Abstract

Low-intensity shockwave therapy (Li-ESWT) has been shown to be an effective and safe treatment for vasculogenic erectile dysfunction (ED). We aim to evaluate the effectiveness and safety of LiESWT in treating patients affected from vasculogenic ED who did not respond to oral treatment with Phosphodiesterase 5 inhibitors (PDE5-i). It is a multicentric open-label prospective study, in a cohort of patients non-responders to PDE-5i. Li-ESWT was performed in an outpatient setting by using the following schedule: 3000 shockwaves with an energy of 0.25 mJ/mm2 and a frequency of 4–6 Hz, twice a week for 3 weeks. International Index of Erectile Function, Erection Hardness Score and Sexual Quality of Life-Male questionnaires, and penile doppler ultrasound (PDU) are the outcome measurements. The Student t-test or Wilcoxon signed-rank test were applied to compare variables, with results considered statistically significant at p < 0.05. 106 (97.2%) completed treatment and performed follow-up visit after 4 weeks. At follow up visit, the mean IIEF-EF increased by 8.6 points (13.47 ± 4.61 vs 22.07 ± 5.27; p < 0.0001). A clinically significant improvement of IIEF-EF was achieved in 75 patients (70.7%). An EHS score ≥ 3, sufficient for a full intercourse, was reported by 72 patients (67.9%) at follow-up visit. 37 (34.9%) patients reported a full rigid penis (EHS = 4) after treatment. Li-ESWT treatment was also able to improve quality of life (SQOL-M: 45.56 ± 8.00 vs 55.31 ± 9.56; p < 0.0001). Li-ESWT significantly increased mean PSV (27.79 ± 5.50 vs 41.66 ± 8.59; p < 0.0001) and decreased mean EDV (5.66 ± 2.03 vs 1.93 ± 2.11; p < 0.0001) in PDU. Combination of Li-ESWT and PDE5-i represents an effective and safe treatment for patients affected from ED who do not respond to first line oral therapy.

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Fig. 1: Study Schedule.

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Author information

Authors and Affiliations

  1. Department of Urology, University Federico II, Naples, Italy

    Alessandro Palmieri & Paolo Verze

  2. Department of Urology, University Vanvitelli, Naples, Italy

    Davide Arcaniolo

  3. San Giacomo Hospital, Monopoli, Bari, Italy

    Fabrizio Palumbo

  4. Department of Urology, University of Trieste, Trieste, Italy

    Giovanni Liguori

  5. Urology Unit, Nuovo San Giovanni di Dio Hospital, Florence, Italy

    Nicola Mondaini

  6. Department of Urology, University of Turin, Turin, Italy

    Marco Falcone

  7. Urology Unit, Ospedale di Circolo di Varese, Varese, Italy

    Fabrizio Idelfonso Scroppo

  8. Department of Urology, University Vita e Salute, San Raffaele, Milan, Italy

    Andrea Salonia

  9. Department of Urology, Santa Chiara Regional Hospital, Trento, Italy

    Tommaso Cai

  10. Department of Urology, University of Florence, Florence, Italy

    Andrea Cocci

  11. Department of Urology, University Vanvitelli, Naples, Italy

    Marco De Sio

  12. Urology Unit, Buccheri La Ferla Fatebenefratelli Hospital, Palermo, Italy

    Danilo Di Trapani

  13. S. Giovanni Calibita Fatebenefratelli, Rome, Italy

    Attilio Guerani

  14. Villa Sofia—CTO Hospital, Palermo, Italy

    Emilio Italiano

  15. Urology Unit, Ospedale di Circolo di Varese, Varese, Italy

    Francesco Marone

  16. Department of Urology, Santa Chiara Regional Hospital, Trento, Italy

    Irene Tamanini

  17. Department of Urology, University of Turin, Turin, Italy

    Massimiliano Timpano

  18. Department of Urology, University of Perugia, Perugia, Italy

    Alessandro Zucchi

Authors
  1. Alessandro Palmieri
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  2. Davide Arcaniolo
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Consortia

SIA-Low intensity shock wave for Erectile Dysfunction (LED) Study Group

  • Andrea Cocci
  • , Marco De Sio
  • , Danilo Di Trapani
  • , Attilio Guerani
  • , Emilio Italiano
  • , Francesco Marone
  • , Irene Tamanini
  • , Massimiliano Timpano
  •  & Alessandro Zucchi

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Correspondence to Tommaso Cai.

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A list of SIA-Low intensity shock wave for Erectile Dysfunction (LED) Study Group members and their affiliations appears at the end of the paper.

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Palmieri, A., Arcaniolo, D., Palumbo, F. et al. Low intensity shockwave therapy in combination with phosphodiesterase-5 inhibitors is an effective and safe treatment option in patients with vasculogenic ED who are PDE5i non-responders: a multicenter single-arm clinical trial. Int J Impot Res 33, 634–640 (2021). https://doi.org/10.1038/s41443-020-0332-7

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