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The Role of the Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Radical Prostatectomy: A Randomized Clinical Trial - Beyond the Abstract

Nowadays, the penile rehabilitation after radical prostatectomy (RP) include the phosphodiesterase-5 inhibitor (PDE5i) as first-line treatment, then intra-cavernous injections, and penile implants. Even with the establishment of robotic platform, this issue stills represents the main and most frequent sequelae following that procedure. Recent evidence has shown that shockwave therapy (SWT) may improve erectile function (EF), specifically in patients with vasculogenic erectile dysfunction (ED). However, none randomized clinical trial (RCT) assessed the effect of SWT post-RP intending to rehabilitate erectile function (EF).

The only literature about the use of the SWT in this scenario was the paper published by Frey et al., which is a pilot study with 16 patients. The authors showed some benefit in favor of SWT at 30-days, but only a mild benefit at 12-months after the last application (+3.5 points and +1.0 points, respectively). In addition, the participants were excluded from the analysis if they reported the use of any erectogenic aid during the study. Zewin et al. also assessed the effect of SWT in men who underwent nerve-sparing radical cystectomy (RC). The authors compared patients receiving SWT (group 1), using PDE5I alone (group 2), and patients without any intervention (group 3: control). After nine months, the authors did not find any difference between the groups. Albeit, the participants submitted to SWT did not receive PDE5i. Therefore, as far as we know our study is the first RCT assessing the effects of SWT post-RP. In addition, we compared patients using PDE5i alone with those receiving the drug plus SWT, once we believe that is the most common way of penile rehabilitation in this setting.

At the end of our study, after 19,200 impulses therapy across eight weeks, we were unable to achieve one of our primary outcomes, a difference of at least 4 points favoring the SWT arm. However, a statistical difference was found between the study groups, which lead us to think about two questions: first, if we continue following this patient and assess them at a longer follow-up, could we achieve better results or a higher difference between the arms? Second, if we offer a more intense protocol with a higher number of applications, could we rehabilitate better these patients, once they usually presenting a severe ED?

Therefore, of course, more studies are needed before any conclusions on this scenario. However, we believe that we are in the right direction doing truth and good research, even if our results are positive or negative in relation to the use of SWT to penile rehabilitation post-RP.  

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Written by: Willy Baccaglini, Cristiano Linck Pazeto, Eduardo Augusto Corrêa Barros, Frederico Timóteo, Leonardo Monteiro, Raiff Yusser Saad Rached, Arthur Navas, Sidney Glina
Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil., Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.

References:

  1. Frey et al. Low-intensity extracorporeal shockwave therapy in the treatment of postprostatectomy erectile dysfunction: a pilot study. Scand J Urol. 2016;50(2):123-7. doi: 10.3109/21681805.2015.1100675. 
  2. Zewin TS, El-Assmy A, Harraz AM, Bazeed M, Shokeir AA, Sheir K, et al. Efficacy and safety of low-intensity shock wave therapy in penile rehabilitation post nerve-sparing radical cystoprostatectomy: a randomized controlled trial. Int Urol Nephrol. 2018. https://doi.org/10.1007/s11255-018-1987-6.
  3. Baccaglini et al. The Role of the Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Radical Prostatectomy: A Randomized Clinical Trial. DOI: https://doi.org/10.1016/j.jsxm.2019.12.024

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