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.

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.

International journal of impotence research. 2020 Jul 18 [Epub ahead of print]

Alessandro Palmieri, Davide Arcaniolo, Fabrizio Palumbo, Paolo Verze, Giovanni Liguori, Nicola Mondaini, Marco Falcone, Fabrizio Idelfonso Scroppo, Andrea Salonia, Tommaso Cai, SIA-Low intensity shock wave for Erectile Dysfunction (LED) Study Group

Department of Urology, University Federico II, Naples, Italy., Department of Urology, University Vanvitelli, Naples, Italy., San Giacomo Hospital, Monopoli, Bari, Italy., Department of Urology, University of Trieste, Trieste, Italy., Urology Unit, Nuovo San Giovanni di Dio Hospital, Florence, Italy., Department of Urology, University of Turin, Turin, Italy., Urology Unit, Ospedale di Circolo di Varese, Varese, Italy., Department of Urology, University Vita e Salute, San Raffaele, Milan, Italy., Department of Urology, Santa Chiara Regional Hospital, Trento, Italy. .