Bryk DJ. et al., 2023: Radial wave therapy does not improve early recovery of erectile function after nerve-sparing radical prostatectomy: a prospective trial

Wednesday, 07 June 2023

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Bryk DJ, Murthy PB, Ericson KJ, Shoskes DA.
Cleveland Clinic Foundation, Glickman Urological and Kidney Institute, Cleveland, OH, USA.
University Hospitals Cleveland Medical Center, Department of Urology, Cleveland, OH, USA.
Senior Medical Director, Pacific Edge, Hummelstown, PA, USA.

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.
Transl Androl Urol. 2023 Feb 28;12(2):209-216. doi: 10.21037/tau-22-310. Epub 2023 Feb 6. PMID: 36915873. FREE ARTICLE

Comments 1

Jens Rassweiler on Wednesday, 07 June 2023 10:30

Low intensity shockwave therapy is an emerging treatment option for men with vasculogenic erectile dysfunction. Basically, all important studies and meta-analyses focused on studies using focal shock wave therapy. Radial wave therapy (rWT) differs from focused shockwave (fSWT) as it produces lower pressure waves with lower peak energy and is used predominantly to treat soft tissue and skin, and muscle disease. There exist some data to support its use in vasculogenic erectile dysfunction, however, there are limited data for the use of rWT for the treatment of erectile dysfunction after nerve-sparing (NS) radical prostatectomy. The authors present a prospective, non-randomized study on the use of rWT for penile rehabilitation after NS radical prostatectomy.

Men with good pre-operative erectile function who underwent a NS radical prostatectomy at the author`s institution from 2018–2020 were considered for inclusion. 106 Men were identified for inclusion with a pre-operative IIEF-5 score ≥17 (with or without a PDE5I) who underwent a bilateral NS RP. Being referral center with patients traveling from great distances for care, many patients would not be able to travel for the weekly rWT treatments. Those unable to participate in the rWT arm were invited to continue our standard care and allow us to monitor their outcomes in the control arm. All post-NS RP patients are offered a PDE5I as part of their baseline penile rehabilitation. Selection of specific PDE5I drug, dosing, and frequency was left to the discretion of the treating surgeon, but most commonly entailed a daily low dose of either sildenafil or tadalafil.

Men enrolled in the rWT arm were treated with 6 consecutive weekly sessions beginning approximately 2 weeks post-operatively. The Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany) device was used to deliver 10,000 “shocks” per treatment at a power of 90 mJ and frequency of 15 Hz. Treatment sites included the distal, mid, and proximal corporal shaft bilaterally as well as the cavernosal neurovascular bundles at the dorsal penopubic junction bilaterally for a total of 8 treatment sites. IIEF-5 scores were collected pre-operatively on all patients undergoing RP in clinic. IIEF-5 and EHS surveys were mailed to participants in both arms to be returned at approximately 6 and 12 weeks post-operatively. The primary endpoint for this study was a comparison of the proportion of men who returned to “near normal” erectile function, defined as IIEF-5 score ≥17 and EHS ≥3, by 3 months post-operatively between the intervention and control arm. Secondary outcomes included comparisons of mean IIEF-5 scores and median EHS between the arms at 6–12 weeks post-operatively.

106 patients were enrolled (62 in the control arm and 44 in the intervention arm) of whom 73 patients had at least one reported survey response between 6 and 12 weeks post-operatively (30 in the control arm and 43 in the intervention arm). 5 (17%) and 11 (26%) patients recovered early erectile function in the control and intervention arms, respectively, which was not a statistically significant difference. 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.

ED after NS RP is multifactorial and can be a result of neural damage (traction on the cavernous nerves), insufficient arterial inflow (related to ligation of pudendal arterial branches), absence of cavernosal oxygenation and neuropraxia-associated damage to erectile tissue resulting in veno-occlusive dysfunction. Recently, Ghahhari et al. presented a multi-centric study on the effect of ESWT on vasculogenic ED and they could not detect significant differences between focal and radial shock wave therapy. The authors used the same protocol (10.000 impulses at 15 Hz). Accordingly, the authors could detect some effect of the EHS, but not significantly impact on the rate of patients receiving “normal erections”. I think, this reflects the actual status of clinical research on ESWT for post-prostatectomy erectile dysfunction. It would be ideal, if any from of shock wave treatment could expedite penile rehabilitation with or without the use of PDE5-inhibitors or even vacuum-devices. Unfortunately, there is no study available, which could provide solid results.

Moreover, there are several limitation with this study as mentioned by the authors: First, the study is not randomized, blinded or sham-controlled, thus leading to a selection bias of patients who opted for the intervention arm. The lack of a sham control also introduces the potential for a placebo benefit in the treatment group compared to the control arm. With the lack of difference between arms in the primary outcome, this selection bias provides further support for the lack of efficacy of rWT on early erectile function recovery after NS RP. The study is also underpowered based on the pre-study power analysis performed, likely as a result of unreturned surveys, with only 73 filled out surveys. The vast majority of those who did not return surveys were from the control arm.
In conclusion radial shock wave therapy might be used to improve post-prostatectomy erectile dysfunction, but this study is not able to provide enough information.

Jens Rassweiler

Men with good pre-operative erectile function who underwent a NS radical prostatectomy at the author`s institution from 2018–2020 were considered for inclusion. 106 Men were identified for inclusion with a pre-operative IIEF-5 score  ≥17 (with or without a PDE5I) who underwent a bilateral NS RP. Being referral center with patients traveling from great distances for care, many patients would not be able to travel for the weekly rWT treatments. Those unable to participate in the rWT arm were invited to continue our standard care and allow us to monitor their outcomes in the control arm. All post-NS RP patients are offered a PDE5I as part of their baseline penile rehabilitation. Selection of specific PDE5I drug, dosing, and frequency was left to the discretion of the treating surgeon, but most commonly entailed a daily low dose of either sildenafil or tadalafil.

Men enrolled in the rWT arm were treated with 6 consecutive weekly sessions beginning approximately 2 weeks post-operatively. The Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany) device was used to deliver 10,000 “shocks” per treatment at a power of 90 mJ and frequency of 15 Hz. Treatment sites included the distal, mid, and proximal corporal shaft bilaterally as well as the cavernosal neurovascular bundles at the dorsal penopubic junction bilaterally for a total of 8 treatment sites. IIEF-5 scores were collected pre-operatively on all patients undergoing RP in clinic. IIEF-5 and EHS surveys were mailed to participants in both arms to be returned at approximately 6 and 12 weeks post-operatively. The primary endpoint for this study was a comparison of the proportion of men who returned to “near normal” erectile function, defined as IIEF-5 score ≥17 and EHS ≥3, by 3 months post-operatively between the intervention and control arm. Secondary outcomes included comparisons of mean IIEF-5 scores and median EHS between the arms at 6–12 weeks post-operatively.

106 patients were enrolled (62 in the control arm and 44 in the intervention arm) of whom 73 patients had at least one reported survey response between 6 and 12 weeks post-operatively (30 in the control arm and 43 in the intervention arm). 5 (17%) and 11 (26%) patients recovered early erectile function in the control and intervention arms, respectively, which was not a statistically significant difference. 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.

ED after NS RP is multifactorial and can be a result of neural damage (traction on the cavernous nerves), insufficient arterial inflow (related to ligation of pudendal arterial branches), absence of cavernosal oxygenation and neuropraxia-associated damage to erectile tissue resulting in veno-occlusive dysfunction. Recently, Ghahhari et al. presented a multi-centric study on the effect of ESWT on vasculogenic ED and they could not detect significant differences between focal and radial shock wave therapy. The authors used the same protocol (10.000 impulses at 15 Hz). Accordingly, the authors could detect some effect of the EHS, but not significantly impact on the rate of patients receiving “normal erections”. I think, this reflects the actual status of clinical research on ESWT for post-prostatectomy erectile dysfunction. It would be ideal, if any from of shock wave treatment could expedite penile rehabilitation with or without the use of PDE5-inhibitors or even vacuum-devices. Unfortunately, there is no study available, which could provide solid results.

Moreover, there are several limitation with this study as mentioned by the authors: First, the study is not randomized, blinded or sham-controlled, thus leading to a selection bias of patients who opted for the intervention arm. The lack of a sham control also introduces the potential for a placebo benefit in the treatment group compared to the control arm. With the lack of difference between arms in the primary outcome, this selection bias provides further support for the lack of efficacy of rWT on early erectile function recovery after NS RP. The study is also underpowered based on the pre-study power analysis performed, likely as a result of unreturned surveys, with only 73 filled out surveys. The vast majority of those who did not return surveys were from the control arm. 
In conclusion radial shock wave therapy might be used to improve post-prostatectomy erectile dysfunction, but this study is not able to provide enough information.

Jens Rassweiler

Low intensity shockwave therapy is an emerging treatment option for men with vasculogenic erectile dysfunction. Basically, all important studies and meta-analyses focused on studies using focal shock wave therapy. Radial wave therapy (rWT) differs from focused shockwave (fSWT) as it produces lower pressure waves with lower peak energy and is used predominantly to treat soft tissue and skin, and muscle disease. There exist some data to support its use in vasculogenic erectile dysfunction, however, there are limited data for the use of rWT for the treatment of erectile dysfunction after nerve-sparing (NS) radical prostatectomy. The authors present a prospective, non-randomized study on the use of rWT for penile rehabilitation after NS radical prostatectomy. Men with good pre-operative erectile function who underwent a NS radical prostatectomy at the author`s institution from 2018–2020 were considered for inclusion. 106 Men were identified for inclusion with a pre-operative IIEF-5 score ≥17 (with or without a PDE5I) who underwent a bilateral NS RP. Being referral center with patients traveling from great distances for care, many patients would not be able to travel for the weekly rWT treatments. Those unable to participate in the rWT arm were invited to continue our standard care and allow us to monitor their outcomes in the control arm. All post-NS RP patients are offered a PDE5I as part of their baseline penile rehabilitation. Selection of specific PDE5I drug, dosing, and frequency was left to the discretion of the treating surgeon, but most commonly entailed a daily low dose of either sildenafil or tadalafil. Men enrolled in the rWT arm were treated with 6 consecutive weekly sessions beginning approximately 2 weeks post-operatively. The Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany) device was used to deliver 10,000 “shocks” per treatment at a power of 90 mJ and frequency of 15 Hz. Treatment sites included the distal, mid, and proximal corporal shaft bilaterally as well as the cavernosal neurovascular bundles at the dorsal penopubic junction bilaterally for a total of 8 treatment sites. IIEF-5 scores were collected pre-operatively on all patients undergoing RP in clinic. IIEF-5 and EHS surveys were mailed to participants in both arms to be returned at approximately 6 and 12 weeks post-operatively. The primary endpoint for this study was a comparison of the proportion of men who returned to “near normal” erectile function, defined as IIEF-5 score ≥17 and EHS ≥3, by 3 months post-operatively between the intervention and control arm. Secondary outcomes included comparisons of mean IIEF-5 scores and median EHS between the arms at 6–12 weeks post-operatively. 106 patients were enrolled (62 in the control arm and 44 in the intervention arm) of whom 73 patients had at least one reported survey response between 6 and 12 weeks post-operatively (30 in the control arm and 43 in the intervention arm). 5 (17%) and 11 (26%) patients recovered early erectile function in the control and intervention arms, respectively, which was not a statistically significant difference. 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. ED after NS RP is multifactorial and can be a result of neural damage (traction on the cavernous nerves), insufficient arterial inflow (related to ligation of pudendal arterial branches), absence of cavernosal oxygenation and neuropraxia-associated damage to erectile tissue resulting in veno-occlusive dysfunction. Recently, Ghahhari et al. presented a multi-centric study on the effect of ESWT on vasculogenic ED and they could not detect significant differences between focal and radial shock wave therapy. The authors used the same protocol (10.000 impulses at 15 Hz). Accordingly, the authors could detect some effect of the EHS, but not significantly impact on the rate of patients receiving “normal erections”. I think, this reflects the actual status of clinical research on ESWT for post-prostatectomy erectile dysfunction. It would be ideal, if any from of shock wave treatment could expedite penile rehabilitation with or without the use of PDE5-inhibitors or even vacuum-devices. Unfortunately, there is no study available, which could provide solid results. Moreover, there are several limitation with this study as mentioned by the authors: First, the study is not randomized, blinded or sham-controlled, thus leading to a selection bias of patients who opted for the intervention arm. The lack of a sham control also introduces the potential for a placebo benefit in the treatment group compared to the control arm. With the lack of difference between arms in the primary outcome, this selection bias provides further support for the lack of efficacy of rWT on early erectile function recovery after NS RP. The study is also underpowered based on the pre-study power analysis performed, likely as a result of unreturned surveys, with only 73 filled out surveys. The vast majority of those who did not return surveys were from the control arm. In conclusion radial shock wave therapy might be used to improve post-prostatectomy erectile dysfunction, but this study is not able to provide enough information. Jens Rassweiler

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