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Motil I. et al., 2022: Linear Low-Intensity Extracorporeal Shockwave Therapy as a Method for Penile Rehabilitation in Erectile Dysfunction Patients after Radical Prostatectomy: A Randomized, Single-Blinded, Sham-Controlled Clinical Trial

Motil I, Macik D, Sramkova K, Jarkovsky J, Sramkova T.
Urology/Andrology Center, Campus Klinika, Brno, Czechia.
Urology Department of Masaryk Memorial Cancer Institute (MMCI), Brno, Czechia.
Urology Department, St. Anna Hospital, Brno, Czechia.
Institute of Biostatistics and Analyses (IBA FM MU), Faculty of Medicine, Masaryk University, Brno, Czechia.
Department of Urology and Institute of Sexology, General University Hospital, First Faculty of Medicine, Charles University Prague, Prague, Czechia.
Department of Sexology, University Hospital and Department of Traumatology, Masaryk University, Brno, Czechia.

Abstract

Introduction: The objective of this study was to investigate the effect and feasibility of linear low-intensity extracorporeal shockwave therapy (LI-LiESWT) as a penile rehabilitation method for erectile dysfunction (ED) after bilateral nerve-sparing (NS) radical prostatectomy (RP).

Methods: Patients who had undergone bilateral NS RP (either radical retropubic prostatectomy or robot-assisted laparoscopic RP), 3 or more months prior to the study, and who had no ED preoperatively and were suffering from mild to severe postoperative ED were included in the study. Four treatments were given over a 4-week period, using the PiezoWave2 device with a linear shockwave applicator and the linear shockwave tissue coverage (LSTC-ED®) technique. If the improvement in erectile function was still considered insufficient (less than an IIEF-5 score of 22-25) at 2 months after the start of LI-LiESWT, penile rehabilitation was supplemented by pharmacological penile rehabilitation. The final effect of treatment was evaluated after 12 months. The main outcome measure was changes in the five-item International Index of Erectile Function (IIEF-5) score.

Results: Between September 2019 and September 2020, a total of 40 patients were included in the study and randomly divided into 2 groups: treatment group and sham group. Eight patients were excluded from the study and were not evaluated due to other conditions which required additional treatment (COVID-19 disease, postoperative incontinence, urethral stricture, and ischemic stroke). Thirty-two patients were included in the final analysis: 16 in the control group and 16 in the intervention group. At 6 months from the end of treatment, patients in both the treatment and the sham group achieved physiological IIEF-5 values, and the beneficial effect persisted for 12 months after the end of treatment.

Conclusions: LI-LiESWT using the LSTC-ED® technique is a suitable and safe method for penile rehabilitation in patients with ED after bilateral NS RP, not only because of the vasculogenic effect of LI-LiESWT but also because of its neuroprotective and/or regenerative effects.
Urol Int. 2022;106(10):1050-1055. doi: 10.1159/000525973. Epub 2022 Aug 10.

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Comments 1

Jens Rassweiler on Wednesday, 11 January 2023 09:30

Erectile dysfunction (ED) represents a common side effect following radical prostatectomy (RP). Recent studies showed promising results using low-intensity extracorporeal shock wave therapy for penile rehabilitation after RP. However, there are only few randomized clinical trials.
This study represents a prospective randomized, single-blinded and sham controlled clinical trial. 40 patients who had undergone bilateral nerve-sparing RP (retropubic or robot-assisted laparoscopic), 3 or more months prior to the study, and who had no ED preoperatively suffering from mild to severe postoperative ED were included in the study. Finally, both groups consisted of 16 patients each.

Four treatments were given over a 4-week period, using the PiezoWave2 device with a linear shockwave applicator. 2,000 shocks with an energy flux density of 0.16 mJ/mm2 and a focal shockwave depth of 10 mm were applied at a frequency of 8 Hz to the penile shaft and 2,000 shocks with the same parameters over the crura of the penis (= 8000 impulses per session). In the placebo group, a special therapy source was used with a gel head that blocked shockwaves. Two months after the end of the treatment, se- lected patients were additionally allowed to take the PDE5i tadalafil 5 mg daily, and after 6 months, they were permitted top- ical or intracavernous prostaglandin E1. The final treatment outcomes were evaluated after 12 months. The main outcome measure was changes in the five-item International Index of Erectile Function (IIEF-5) scores.

None of the patients complained of pain or any ad- verse effects following treatment with Li-ESWT. Interestingly, the authors monitored the effect of Li-ESWT over time: After two months, the difference between the groups was statistically significant (IIEF-5 scores: 10.1 ± 3.4 vs. 7.6 ± 1.9, p = 0.005). However, the clinical improvement was not significant. Tadalafil 5 mg daily was therefore additionally given to both groups to potentiate the effect of penile rehabilitation. A statistically significant difference persisted between the two groups after 3 months of treatment (IIEF-5 scores: 15.6 ± 3.7 vs. 10.9 ± 3.3, p = 0.001). After 3 months, both groups received standard treatment for ED according to the EAU Guidelines, with PDE5i administered on demand or topical/intracavernous prostaglandin E1. After 6 months, patients in both the treatment and the sham group had achieved physiological IIEF-5 scores, and the beneficial effect of combination therapy persisted for 12 months after the end of treatment.


https://www.storzmedical.com/images/blog/Motil.png

Although all urological surgeons use NS surgical techniques, the reported rate of ED at 12 months postopera- tively still ranges from 54% to 90%. Post-RP ED is mainly caused by temporary or permanent injury to NVBs as a result of intraoperative manipulations such as traction, compression, and coagulation. Long-term lasting nerve degeneration and penile hypoxia lead to structural remodeling of cavernous tissues with smooth muscle apoptosis, fibrosis, and sinusoidal obstruction. Thus early treatment of postoperative ED is of upmost importance. The main methods for penile rehabilitation include daily oral administration of PDE5i and topical administration or intracavernosal injection of prostaglandin E1. In this scenario, early use of Li-ESWT to promote penile rehabilitation could accelerate neural recovery and improve tissue regeneration, blood flow, and cavernosal oxygenation, pre- venting cavernous tissue remodeling.

The results show that during penile rehabilitation with the help of SW, better and faster protection of the cavernous tissues has been achieved in the group with effective treatment. Nevertheless it is clear that the use of Li-ESWT to treat post-RP ED deserves further validation. However, the authors believe that further clinical studies on the use of Li-ESWT for vascular penile rehabilitation in patients after RP will support our optimistic conclusions summarized below. Probably, patients should be treated earlier (in this study mean of 7 months after surgery). The authors state that Li-ESWT using the LSTC-ED® technique can be used for penile rehabilitation in patients with ED after bilateral NS RP, not only because of its vasculogenic effect but also because of its neuroprotective and/or regenerative effects.

Based on others studies, it still remains uncertain, whether linear shock wave source provides any advantages of a focal source. This is mainly because during ESWT-treatment using a focal shock wave source (i.e. Duolith SD), the impulses are distributed over the respected area (i.e. basis, distal, shaft). Thus, a linear applicator may not provide better saturation.


Jens Rassweiler

Erectile dysfunction (ED) represents a common side effect following radical prostatectomy (RP). Recent studies showed promising results using low-intensity extracorporeal shock wave therapy for penile rehabilitation after RP. However, there are only few randomized clinical trials. This study represents a prospective randomized, single-blinded and sham controlled clinical trial. 40 patients who had undergone bilateral nerve-sparing RP (retropubic or robot-assisted laparoscopic), 3 or more months prior to the study, and who had no ED preoperatively suffering from mild to severe postoperative ED were included in the study. Finally, both groups consisted of 16 patients each. Four treatments were given over a 4-week period, using the PiezoWave2 device with a linear shockwave applicator. 2,000 shocks with an energy flux density of 0.16 mJ/mm2 and a focal shockwave depth of 10 mm were applied at a frequency of 8 Hz to the penile shaft and 2,000 shocks with the same parameters over the crura of the penis (= 8000 impulses per session). In the placebo group, a special therapy source was used with a gel head that blocked shockwaves. Two months after the end of the treatment, se- lected patients were additionally allowed to take the PDE5i tadalafil 5 mg daily, and after 6 months, they were permitted top- ical or intracavernous prostaglandin E1. The final treatment outcomes were evaluated after 12 months. The main outcome measure was changes in the five-item International Index of Erectile Function (IIEF-5) scores. None of the patients complained of pain or any ad- verse effects following treatment with Li-ESWT. Interestingly, the authors monitored the effect of Li-ESWT over time: After two months, the difference between the groups was statistically significant (IIEF-5 scores: 10.1 ± 3.4 vs. 7.6 ± 1.9, p = 0.005). However, the clinical improvement was not significant. Tadalafil 5 mg daily was therefore additionally given to both groups to potentiate the effect of penile rehabilitation. A statistically significant difference persisted between the two groups after 3 months of treatment (IIEF-5 scores: 15.6 ± 3.7 vs. 10.9 ± 3.3, p = 0.001). After 3 months, both groups received standard treatment for ED according to the EAU Guidelines, with PDE5i administered on demand or topical/intracavernous prostaglandin E1. After 6 months, patients in both the treatment and the sham group had achieved physiological IIEF-5 scores, and the beneficial effect of combination therapy persisted for 12 months after the end of treatment. [img]https://www.storzmedical.com/images/blog/Motil.png[/img] Although all urological surgeons use NS surgical techniques, the reported rate of ED at 12 months postopera- tively still ranges from 54% to 90%. Post-RP ED is mainly caused by temporary or permanent injury to NVBs as a result of intraoperative manipulations such as traction, compression, and coagulation. Long-term lasting nerve degeneration and penile hypoxia lead to structural remodeling of cavernous tissues with smooth muscle apoptosis, fibrosis, and sinusoidal obstruction. Thus early treatment of postoperative ED is of upmost importance. The main methods for penile rehabilitation include daily oral administration of PDE5i and topical administration or intracavernosal injection of prostaglandin E1. In this scenario, early use of Li-ESWT to promote penile rehabilitation could accelerate neural recovery and improve tissue regeneration, blood flow, and cavernosal oxygenation, pre- venting cavernous tissue remodeling. The results show that during penile rehabilitation with the help of SW, better and faster protection of the cavernous tissues has been achieved in the group with effective treatment. Nevertheless it is clear that the use of Li-ESWT to treat post-RP ED deserves further validation. However, the authors believe that further clinical studies on the use of Li-ESWT for vascular penile rehabilitation in patients after RP will support our optimistic conclusions summarized below. Probably, patients should be treated earlier (in this study mean of 7 months after surgery). The authors state that Li-ESWT using the LSTC-ED® technique can be used for penile rehabilitation in patients with ED after bilateral NS RP, not only because of its vasculogenic effect but also because of its neuroprotective and/or regenerative effects. Based on others studies, it still remains uncertain, whether linear shock wave source provides any advantages of a focal source. This is mainly because during ESWT-treatment using a focal shock wave source (i.e. Duolith SD), the impulses are distributed over the respected area (i.e. basis, distal, shaft). Thus, a linear applicator may not provide better saturation. Jens Rassweiler
Thursday, 18 July 2024