Abstract and Introduction
Abstract
Background: Low intensity shockwave therapy is an emerging treatment option for men with vasculogenic erectile dysfunction. Radial wave therapy (rWT), which differs from focused shockwave (fSWT) as it produces lower pressure waves with lower peak energy, is used to treat soft tissue and skin conditions and has some data to support its use in vasculogenic erectile dysfunction. There is limited data for the use of rWT for the treatment of erectile dysfunction after nerve-sparing (NS) radical prostatectomy. We report the first trial of rWT for penile rehabilitation after NS radical prostatectomy.
Methods: We performed a prospective, non-randomized, open-label trial. Men with good pre-operative erectile function who underwent a NS radical prostatectomy at our institution from 2018–2020 were considered for inclusion. We compared post-operative erectile function outcomes between the rWT (6 weekly treatments initiated approximately 2 weeks post-operatively) plus standard of care (phosphodiesterase type 5 inhibitor) arm and the non-sham controlled standard of care arm. The primary end point for our study was the proportion of men who returned to "near normal" erectile function, defined as IIEF-5 score ≥17 and erectile hardness score (EHS) ≥3, by 3 months post-operatively between the intervention and control arm. We also compared mean IIEF-5 scores and median EHSs between the arms.
Results: One hundred and six patients were enrolled, of whom 73 patients had at least one reported survey response between 6 and 12 weeks post-operatively. Five (17%) and 11 (26%) patients recovered erectile function in the control and intervention arms, respectively, which was not a statistically significant difference (P=0.37). However, the intervention arm did have a significantly higher median EHS compared to the control arm (1 vs. 2, P=0.03). There were 4 adverse events related to pain during treatment and required only treatment intensity de-escalation.
Conclusions: rWT is safe but did not substantially improve the recovery of early erectile function after NS radical prostatectomy.
Introduction
Low intensity shockwave therapy (SWT) is an emerging treatment option for men with vasculogenic erectile dysfunction (ED). The efficacy of SWT in this setting has been evaluated in several meta-analyses of randomized trials suggesting that men with vasculogenic ED experience a significant improvement in erectile function after SWT.[1–4] The role of SWT in the post-radical prostatectomy (RP) setting for penile rehabilitation,[5] however, is less clear, as the original randomized trials of SWT only enrolled men with vasculogenic ED and excluded men who had undergone RP.
The proposed mechanism of action of SWT—microtrauma that stimulates angiogenesis, stem cell proliferation, and nerve regeneration—suggests some potential for clinical efficacy in the post-RP setting.[6,7] Furthermore, studies in rat models of cavernosal nerve injury suggest SWT may restore penile blood flow via revascularization and neuronal regeneration.[7,8] There have been 5 studies evaluating SWT in the post-RP setting and 1 post-cystoprostatectomy, 3 of which were randomized controlled trials;[9–14] these studies support the safety of low-intensity SWT after prostate surgery, but the clinical outcomes from these studies were underwhelming, noting only small increases in international index of erectile function-5 (IIEF-5) score and erectile hardness score (EHS).[11–13]
The pre-clinical data and clinical trials supporting the utility of SWT in ED uniformly used low-intensity focused shockwaves (fSWT). Radial wave therapy (rWT) is an alternative method of creating acoustic waves that differ from fSWT by having lower pressure waves that produce lower peak energy and thus low tissue penetrance.[15–17] rWT is commonly utilized in orthopedics, physical therapy, and dermatology.[18–21] The data supporting the use of rWT in ED is limited;[22] at our institution the results of rWT treatment for men with vasculogenic ED was equivalent to fSWT.[23] However, Sandoval-Salinas et al. found no difference between rWT and sham.[24] Despite the limited data, rWT is often marketed directly to consumers as evidence-based treatment for ED.[25] rWT has not yet been evaluated in the post-RP setting.
Here we report the first trial of rWT for penile rehabilitation after nerve-sparing (NS) RP. We hypothesized that rWT in addition to a phosphodiesterase type 5 inhibitor (PDE5I) would improve early recovery of erectile function following RP compared with a PDE5I alone. We present the following article in accordance with the TREND reporting checklist (available at https://tau.amegroups.com/article/view/10.21037/tau-22-310/rc).
Transl Androl Urol. 2023;12(2):209-216. © 2023 AME Publishing Company
