Ghahhari J. et al., 2022: Shockwave Therapy for Erectile Dysfunction: Which Gives the Best Results? A Retrospective National, Multi-Institutional Comparative Study of Different Shockwave Technologies

Wednesday, 21 September 2022

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Ghahhari J, De Nunzio C, Lombardo R, Ferrari R, Gatti L, Ghidini N, Calarco Piazza R, Faieta A, Cindolo L.
Department of Urology, Private Hospital Villa Stuart, Rome, Italy.
Department of Urology, "Sant'Andrea" Hospital, "La Sapienza" University, Rome, Italy.
Department of Urology, University of Modena and Reggio Emilia, Modena, Italy.
Department of Urology, Hesperia Hospital, CUrE Group, Modena, Italy.

Abstract

Background: Low-intensity shockwave therapy (Li-SWT) is a promising option for the treatment of erectile dysfunction (ED). Many devices with different characteristics in terms of generators, shockwaves, set-up parameters and procedure protocols are commercially available. In this report, we present our experience with the main shockwave technologies currently in use in clinical practice for ED treatment.

Methods: A retrospective national, multi-institutional study was performed to compare the effects of different shockwave technologies in ED patients. All of the subjects underwent 8 consecutive weekly physical treatments with SWT under either a focused or non-focused regimen: 3,000 shocks per session at 0.09 mJ/mm2 and 10,000 shocks per session at 15 Hz and 90 mJ, respectively. Efficacy was evaluated by comparing pre- and post-treatment Sexual Health Inventory in Men (SHIM) scores, International Index of Erectile Function (IIEF-5) and Erection Hardness Score (EHS). Possible relationships between type of shockwave generator, source, morphology and type of ED were investigated.

Results: A total of 94 men were included in the analysis. There were no significant differences in the baseline clinical characteristics or demographics. The mean (SD) increase in the scores from questionnaires evaluated at 8 weeks was clinically and statistically significant, with overall improvements of +5.49, +5.47 and +1.18 (p<0.0001) in the IIEF-5, SHIM, and EHS scores, respectively. The increases in these scores were evaluated by a multiple regression analysis, in relation to the shockwave generator, type of ED, shockwave source and morphology, but none of the factors examined predicted improvement. No side effects were reported with any device.

Conclusions: SWT is a clinically effective and safe treatment for ED that is independent of the generator type, source, shockwave morphology emitted, type of ED and perhaps treatment protocol.
Surg Technol Int. 2022 May 19;40:213-218. doi: 10.52198/22.STI.40.UR1556. PMID: 35362088

Comments 1

Jens Rassweiler on Wednesday, 21 September 2022 10:40

Extracoporeal shock wave therapy (ESWT) represents an important option in the clinical treatment of men with vasculogenic ED. Several single-arm randomized clinical trials (RC T) and meta-analyses have reported very promising results and the significant improvement of ED after ESWT. There is still a debate due to the diversity of shockwave generators (electrohydraulic, electromagnetic, piezoelectric or electropneumatic), shockwaves emitted (focused and non- focused waves), set-up parameters (energy flux density, number of pulses per session), and procedure protocols (duration of treatment course, number of sessions per week, total number of shockwave pulses delivered, penile sites of application).
The two main types of shock waves delivered are focused and non-focused (radial) shock waves, which differ with respect to the depth of penetration, the shape of the wave and the ability to apply.
A retrospective national, multi-institutional comparative study of patients with ED who were treated with different shockwave technologies between July 2020 and September 2021 was started at four centers. Using four different shockwave systems:
- BTL 6000-SWT® (BTL-Medizintechnik, Germany) electro-acoustic generator, focused-wave morphology;
- EMS Swiss Dolorclast®, (EMS Electro Medical Systems SA, Switzerland), electropneumatic generator, radial-wave morphology;
- E100® (Shenzhen Huikang Medical Apparatus Co., Ltd., China), electromagnetic generator, radial-wave morphology;
- Piezowave® (Richard Wolf GmbH, Knittlingen, Ger-many), piezoelectric generator, linear- wave morphology).
All patients received 8 ESWTs (focused or unfocused) with a week interval; The focused regimen provided 3,000 shocks per session at 0.09 mJ/mm2 and the non-focused regimen entailed 10,000 shocks per session at 15 Hz and 90 mJ. Shockwaves were administered to the penis at 6 sites; 1 at each crus and 2 on the shaft bilaterally.
Efficacy was evaluated after 8 weeks of shockwave treatment by the International Index of Erectile Function (IIEF-5), Sexual Health Inventory in Men (SHIM), and Erection Hardness Score (EHS). An active follow-up was done at 12 months to evaluate the retreatment rate. The variation (∆) in SHIM scores among subgroups was 6.80, 4.75, 5.60, and 4.43, respectively, with no statistically significant differences.

This study clearly proves the efficacy of shockwave treatment for vasculogenic erectile dysfunction (ED), but it also rises several questions about the application modes. Most studies in the literature used focal shock wave application with an energy density comparable to this study (ie. 0.09 mJ/mm2) and the administration of 3000 shock waves to the penis at six sites. Also, the centers who used radial (unfocused) shock waves followed previous protocols (10,000 impulses at 15 Hz). Studies comparing radial and focal shock waves did not find any significant differences, too. There are similar studies using linear shock wave application, showing the same efficacy. The authors concluded that the overall amount of the shock wave energy might be most relevant rather the type of shock wave source and way of application.

These questions are very interesting, because future studies should be based on relevant protocols. On the other side, we know already from lithotripsy, that the overall efficacy of ESWL also does not depend on the type of the shock wave source (piezoelectric, electrohydraulic, electromagnetic). Since during focal and radial shock application the probe does not remain on one spot, the differences related to the tissue compared to a linear application might be irrelevant. The advantage of a linear shock wave application could be a more homogenous distribution of shock wave energy. Moreover, there are no dose-finding studies and obviously this might be very difficult to carry out.

There is a very interesting review by Würfel et al. on the effect of different types of shock waves on biological tissue (Biomedicines 2022, 10(5), 1084) which clearly states, that the bio-effect of radial and focal shock wave therapy is similar. Based on this, the results of this study may be not so surprising.

Jens Rassweiler

This study clearly proves the efficacy of shockwave treatment for vasculogenic erectile dysfunction (ED), but it also rises several questions about the application modes. Most studies in the literature used focal shock wave application with an energy density comparable to this study (ie. 0.09 mJ/mm2) and the administration of 3000 shock waves to the penis at six sites. Also, the centers who used radial (unfocused) shock waves followed previous protocols (10,000 impulses at 15 Hz). Studies comparing radial and focal shock waves did not find any significant differences, too.  There are similar studies using linear shock wave application, showing the same efficacy. The authors concluded that the overall amount of the shock wave energy might be most relevant rather the type of shock wave source and way of application.

These questions are very interesting, because future studies should be based on relevant protocols. On the other side, we know already from lithotripsy, that the overall efficacy of ESWL also does not depend on the type of the shock wave source (piezoelectric, electrohydraulic, electromagnetic).  Since during focal and radial shock application the probe does not remain on one spot, the differences related to the tissue compared to a linear application might be irrelevant. The advantage of a linear shock wave application could be a more homogenous distribution of shock wave energy. Moreover, there are no dose-finding studies and obviously this might be very difficult to carry out.

There is a very interesting review by Würfel et al.  on the effect of different types of shock waves on biological tissue (Biomedicines 2022, 10(5), 1084) which clearly states, that the bio-effect of radial and focal shock wave therapy is similar. Based on this, the results of this study may be not so surprising.

Jens Rassweiler

Extracoporeal shock wave therapy (ESWT) represents an important option in the clinical treatment of men with vasculogenic ED. Several single-arm randomized clinical trials (RC T) and meta-analyses have reported very promising results and the significant improvement of ED after ESWT. There is still a debate due to the diversity of shockwave generators (electrohydraulic, electromagnetic, piezoelectric or electropneumatic), shockwaves emitted (focused and non- focused waves), set-up parameters (energy flux density, number of pulses per session), and procedure protocols (duration of treatment course, number of sessions per week, total number of shockwave pulses delivered, penile sites of application). The two main types of shock waves delivered are focused and non-focused (radial) shock waves, which differ with respect to the depth of penetration, the shape of the wave and the ability to apply. A retrospective national, multi-institutional comparative study of patients with ED who were treated with different shockwave technologies between July 2020 and September 2021 was started at four centers. Using four different shockwave systems: - BTL 6000-SWT® (BTL-Medizintechnik, Germany) electro-acoustic generator, focused-wave morphology; - EMS Swiss Dolorclast®, (EMS Electro Medical Systems SA, Switzerland), electropneumatic generator, radial-wave morphology; - E100® (Shenzhen Huikang Medical Apparatus Co., Ltd., China), electromagnetic generator, radial-wave morphology; - Piezowave® (Richard Wolf GmbH, Knittlingen, Ger-many), piezoelectric generator, linear- wave morphology). All patients received 8 ESWTs (focused or unfocused) with a week interval; The focused regimen provided 3,000 shocks per session at 0.09 mJ/mm2 and the non-focused regimen entailed 10,000 shocks per session at 15 Hz and 90 mJ. Shockwaves were administered to the penis at 6 sites; 1 at each crus and 2 on the shaft bilaterally. Efficacy was evaluated after 8 weeks of shockwave treatment by the International Index of Erectile Function (IIEF-5), Sexual Health Inventory in Men (SHIM), and Erection Hardness Score (EHS). An active follow-up was done at 12 months to evaluate the retreatment rate. The variation (∆) in SHIM scores among subgroups was 6.80, 4.75, 5.60, and 4.43, respectively, with no statistically significant differences. This study clearly proves the efficacy of shockwave treatment for vasculogenic erectile dysfunction (ED), but it also rises several questions about the application modes. Most studies in the literature used focal shock wave application with an energy density comparable to this study (ie. 0.09 mJ/mm2) and the administration of 3000 shock waves to the penis at six sites. Also, the centers who used radial (unfocused) shock waves followed previous protocols (10,000 impulses at 15 Hz). Studies comparing radial and focal shock waves did not find any significant differences, too. There are similar studies using linear shock wave application, showing the same efficacy. The authors concluded that the overall amount of the shock wave energy might be most relevant rather the type of shock wave source and way of application. These questions are very interesting, because future studies should be based on relevant protocols. On the other side, we know already from lithotripsy, that the overall efficacy of ESWL also does not depend on the type of the shock wave source (piezoelectric, electrohydraulic, electromagnetic). Since during focal and radial shock application the probe does not remain on one spot, the differences related to the tissue compared to a linear application might be irrelevant. The advantage of a linear shock wave application could be a more homogenous distribution of shock wave energy. Moreover, there are no dose-finding studies and obviously this might be very difficult to carry out. There is a very interesting review by Würfel et al. on the effect of different types of shock waves on biological tissue (Biomedicines 2022, 10(5), 1084) which clearly states, that the bio-effect of radial and focal shock wave therapy is similar. Based on this, the results of this study may be not so surprising. Jens Rassweiler

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