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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 - Beyond the Abstract

Recent achievements in pathophysiology and the physiological mechanism of erectile dysfunction (ED) improved the armamentarium and the outcome of its management with positive effects on the patients’ quality of life. Particularly, recent evidence highlighted the role of low-intensity shockwave therapy (Li-ESWT) in the treatment of vasculogenic erectile dysfunction. From the initial experience of Vardi and co-workers in 2012, several studies have been carried out and several shockwaves electromagnetic generators have been introduced into clinical practice.1-2 The findings obtained with low-intensity shockwave therapy in the treatment for erectile dysfunction have been confirmed by a recent meta-analysis of randomized controlled trials.2 The idea of this study comes from the evidence that in everyday clinical practice, Li-ESWT could convert PDE5-inhibitors non-responders into responders, significantly and persistently improving erection quality.3 From this background, the questions are: Should Li-ESWT be considered as a safe and effective treatment in patients affected by vasculogenic erectile dysfunction who did not respond to oral treatment with PDE5-inhibitors? Does Li-ESWT play an interesting role in the improvement of penile blood flow at penile Doppler ultrasound evaluation?


By using a multicentric open-label prospective study carried out in eight Italian centers under the coordination of the Italian Society of Andrology (SIA) on 106 patients affected by ED unresponsive to oral PDE5-inhibitors, we found a clinically significant improvement in erection quality.4 Indeed, a clinically significant improvement of IIEF-EF was achieved in 75 patients (70.7%) and Erection Hardness Score ≥ 3, sufficient for full intercourse, was reported by 72 patients (67.9%) at the follow-up visit. 37 (34.9%) patients reported a full rigid penis (EHS=4) after treatment.4 Moreover, 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) and 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 penile doppler ultrasound.4 On the basis of our findings, we consider that the 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. Future studies should be planned and performed to confirm our findings, but we highlighted that the management of ED should be based on multiple treatments especially in first-line unresponsive patients.

Written by: Tommaso Cai1 and Alessandro Palmieri2

  1. Department of Urology, Santa Chiara Regional Hospital, Trento, Italy.
  2. Department of Urology, University of Naples, Federico II, Naples, Italy.
References:

  1. Gruenwald, Ilan, Boaz Appel, and Yoram Vardi. "Low‐intensity extracorporeal shock wave therapy—A novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy." The journal of sexual medicine 9, no. 1 (2012): 259-264.
  2. Sokolakis, Ioannis, and Georgios Hatzichristodoulou. "Clinical studies on low intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic review and meta-analysis of randomised controlled trials." International journal of impotence research 31, no. 3 (2019): 177-194.
  3. Kitrey, Noam D., Ilan Gruenwald, Boaz Appel, Arik Shechter, Omar Massarwa, and Yoram Vardi. "Penile low intensity shock wave treatment is able to shift PDE5i nonresponders to responders: a double-blind, sham controlled study." The Journal of Urology 195, no. 5 (2016): 1550-1555.
  4. Palmieri, Alessandro, Davide Arcaniolo, Fabrizio Palumbo, Paolo Verze, Giovanni Liguori, Nicola Mondaini, Marco Falcone, Fabrizio Idelfonso Scroppo, Andrea Salonia, and Tommaso Cai. "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 (2020): 1-7.
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