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Palmieri A. et al., 2020: 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

Palmieri A, Arcaniolo D, Palumbo F, Verze P, Liguori G, Mondaini N, Falcone M, Scroppo FI, Salonia A, Cai T.
Department of Urology, University Federico II, Naples, Italy.
Department of Urology, University Vanvitelli, Naples, Italy.
San Giacomo Hospital, Monopoli, Bari, Italy.
Department of Urology, University of Trieste, Trieste, Italy.
Urology Unit, Nuovo San Giovanni di Dio Hospital, Florence, Italy.
Department of Urology, University of Turin, Turin, Italy.
Urology Unit, Ospedale di Circolo di Varese, Varese, Italy.
Department of Urology, University Vita e Salute, San Raffaele, Milan, Italy.
Department of Urology, Santa Chiara Regional Hospital, Trento, Italy.

Abstract

Low-intensity shockwave therapy (Li-ESWT) has been shown to be an effective and safe treatment for vasculogenic erectile dysfunction (ED). We aim to evaluate the effectiveness and safety of LiESWT in treating patients affected from vasculogenic ED who did not respond to oral treatment with Phosphodiesterase 5 inhibitors (PDE5-i). It is a multicentric open-label prospective study, in a cohort of patients non-responders to PDE-5i. Li-ESWT was performed in an outpatient setting by using the following schedule: 3000 shockwaves with an energy of 0.25 mJ/mm2 and a frequency of 4-6 Hz, twice a week for 3 weeks. International Index of Erectile Function, Erection Hardness Score and Sexual Quality of Life-Male questionnaires, and penile doppler ultrasound (PDU) are the outcome measurements. The Student t-test or Wilcoxon signed-rank test were applied to compare variables, with results considered statistically significant at p < 0.05. 106 (97.2%) completed treatment and performed follow-up visit after 4 weeks. At follow up visit, the mean IIEF-EF increased by 8.6 points (13.47 ± 4.61 vs 22.07 ± 5.27; p < 0.0001). A clinically significant improvement of IIEF-EF was achieved in 75 patients (70.7%). An EHS score ≥ 3, sufficient for a full intercourse, was reported by 72 patients (67.9%) at follow-up visit. 37 (34.9%) patients reported a full rigid penis (EHS = 4) after treatment. 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). Li-ESWT 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 PDU. 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.
Int J Impot Res. 2020 Jul 18. doi: 10.1038/s41443-020-0332-7. Online ahead of print. FREE ARTICLE

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Commentaires 1

Peter Alken le mardi 26 janvier 2021 08:53

The many papers on Li-SWT for erectile dysfunction usually have, like the present publication, a positive optimistic introduction, positive results and a positive outlook. Yet there is always some doubt accompanying these publications. This is well reflected in a recent review by Tom Lue, who is busy with research and the clinical aspects of erectile dysfunction since app. 40 years (1):
“ …the following parameters affect biologic responses: energy flux density (mJ/mm2); number of shocks; frequency of the device (Hz); treatment frequency and interval; resident tissue stem/progenitor cell content (which is affected by age and diseases); shape and focus of the shockwaves; diameter of effective therapeutic area; and energy attenuation. Unfortunately, many articles do not provide detail for the shockwave device characteristics and parameters. This oversight may contribute to the inconsistent results reported by various authors using different devices.”
and “Further large randomized controlled trials with homogeneous populations and adequate follow-up are required to evaluate the efficacy and longevity of potential treatment effects. When examining the studies, LI-ESWT seems to have the best chance of success in patients with mild ED with some response to PDE-5i …” and “Therefore, future trials will need to investigate this group specifically. Until such trials become available, we are unable to recommend LI-ESWT as a standard treatment option for men who are PDE-5i nonresponders. Patients should only be offered LI-ESWT in an investigational setting or as off-label use with a thorough understanding of the risks and benefits.”

The current EAU guidelines express a similar opinion (2): ”data suggest that LI-SWT could ameliorate erection quality even in patients with severe ED who are PDE5Is non-responders or inadequate responders,reducing the immediate need for more invasive treatments. However, prospective RCTs and longer-term follow-up data would provide the clinician with more confidence regarding the use and efficacy of LI-SWT for ED. Further clarity is also needed in defining treatment protocols that can result in greater clinical benefits.
Overall, according to the available data and the novel treatment decision algorithm, patients with vasculogenic ED may be treated with LI-SWT, although they should be fully counselled before treatment.”

The design of the present study fails to clarify the concerns mentioned above. It is an open-label study on a large but very inhomogeneous patient group: “Mean age was 57.9 ± 10.7 (range 21–78) years and duration of ED was 33.3 ± 28.2 (range 3–103) months. Those evaluating the results were not blinded.
The authors mention other limits: ”The absence of a control group with a sham treatment and the short follow-up are the main limitation of our study.” and “Moreover, the lack of a control group cannot allow us to exclude a potential placebo effect of Li-ESWT in treating ED.”
It is unfortunate that the authors did a lot of work but just add to the uncertainties concerning Li-ESWT.

1 Patel P, Fode M, Lue T, Ramasamy R. Should Low-intensity Extracorporeal Shockwave Therapy Be the First-line Erectile Dysfunction Treatment for Nonresponders to Phosphodiesterase Type 5 Inhibition? Eur Urol Focus. 2019 Jul;5(4):526-528. doi: 10.1016/j.euf.2019.02.004

2 https://uroweb.org/guideline/sexual-and-reproductive-health/#5

Peter Alken

The many papers on Li-SWT for erectile dysfunction usually have, like the present publication, a positive optimistic introduction, positive results and a positive outlook. Yet there is always some doubt accompanying these publications. This is well reflected in a recent review by Tom Lue, who is busy with research and the clinical aspects of erectile dysfunction since app. 40 years (1): “ …the following parameters affect biologic responses: energy flux density (mJ/mm2); number of shocks; frequency of the device (Hz); treatment frequency and interval; resident tissue stem/progenitor cell content (which is affected by age and diseases); shape and focus of the shockwaves; diameter of effective therapeutic area; and energy attenuation. Unfortunately, many articles do not provide detail for the shockwave device characteristics and parameters. This oversight may contribute to the inconsistent results reported by various authors using different devices.” and “Further large randomized controlled trials with homogeneous populations and adequate follow-up are required to evaluate the efficacy and longevity of potential treatment effects. When examining the studies, LI-ESWT seems to have the best chance of success in patients with mild ED with some response to PDE-5i …” and “Therefore, future trials will need to investigate this group specifically. Until such trials become available, we are unable to recommend LI-ESWT as a standard treatment option for men who are PDE-5i nonresponders. Patients should only be offered LI-ESWT in an investigational setting or as off-label use with a thorough understanding of the risks and benefits.” The current EAU guidelines express a similar opinion (2): ”data suggest that LI-SWT could ameliorate erection quality even in patients with severe ED who are PDE5Is non-responders or inadequate responders,reducing the immediate need for more invasive treatments. However, prospective RCTs and longer-term follow-up data would provide the clinician with more confidence regarding the use and efficacy of LI-SWT for ED. Further clarity is also needed in defining treatment protocols that can result in greater clinical benefits. Overall, according to the available data and the novel treatment decision algorithm, patients with vasculogenic ED may be treated with LI-SWT, although they should be fully counselled before treatment.” The design of the present study fails to clarify the concerns mentioned above. It is an open-label study on a large but very inhomogeneous patient group: “Mean age was 57.9 ± 10.7 (range 21–78) years and duration of ED was 33.3 ± 28.2 (range 3–103) months. Those evaluating the results were not blinded. The authors mention other limits: ”The absence of a control group with a sham treatment and the short follow-up are the main limitation of our study.” and “Moreover, the lack of a control group cannot allow us to exclude a potential placebo effect of Li-ESWT in treating ED.” It is unfortunate that the authors did a lot of work but just add to the uncertainties concerning Li-ESWT. 1 Patel P, Fode M, Lue T, Ramasamy R. Should Low-intensity Extracorporeal Shockwave Therapy Be the First-line Erectile Dysfunction Treatment for Nonresponders to Phosphodiesterase Type 5 Inhibition? Eur Urol Focus. 2019 Jul;5(4):526-528. doi: 10.1016/j.euf.2019.02.004 2 https://uroweb.org/guideline/sexual-and-reproductive-health/#5 Peter Alken
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jeudi 22 avril 2021

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