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Kurosawa M. et al., 2022: Efficacy and patient satisfaction of low-intensity shockwave treatment for erectile dysfunction in a retrospective real-world study in Japan

Kurosawa M, Tsujimura A, Morino J, Anno Y, Yoshiyama A, Kure A, Uesaka Y, Nozaki T, SHirai M, Kobayashi K, Horie S.
Department of Urology, Juntendo University Urayasu Hospital, Urayasu, Chiba, Japan.
D-Clinic TOKYO, Chiyoda-ku, Tokyo, Japan.
Department of Urology, Juntendo University, Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan.

Abstract

Objectives: To clarify the efficacy of low-intensity extracorporeal shockwave therapy for patients with erectile dysfunction, compare the efficacy between two types of lithotripters (ED1000 [focused type] and Renova [linear type]), and detect factors indicative of therapeutic gain with the treatment.

Methods: This retrospective study included 76 patients (52.8 ± 11.7 years) treated by ED1000 (12 times over 9 weeks) and 484 patients (52.5 ± 11.6 years) treated by Renova (4 times over 4 weeks). Age, sexual symptoms scores, and blood examinations were assessed. Efficacy was judged by improvement of the scores and patient satisfaction and compared between patients at 1 month after treatment with the lithotripters. Independent factors influencing efficacy by Renova were also assessed.

Results: Sexual symptom scores were improved significantly by both lithotripters, although the changes in the scores did not differ significantly between them. Efficacy rate as judged by patient satisfaction was 65.8% with the ED1000 and 71.1% with Renova, also without significant difference. Among several factors including age, sexual symptoms scores, endocrinological factors, metabolic factors, and the rate of phosphodiesterase type 5 inhibitor use, only age was found to be an independent factor influencing the efficacy of Renova.

Conclusion: We clearly showed the high efficacy of both lithotripters. Although the efficacy rate did not differ between them, we speculated that the fewer treatment sessions needed with the Renova versus the ED1000 would be a great advantage for patients. We also suggest that Renova should be recommended for patients younger than 70 years of age.
Int J Urol. 2022 Dec 27. doi: 10.1111/iju.15135. Online ahead of print. PMID: 36575829

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Comments 1

Jens Rassweiler on Monday, 13 February 2023 09:30

This is a retrospective study comparing the outcome of Li-ESWT using two different devices (“lithotripters”) with different principles of shock wave generation (electrohydraulic vs. electromagnetic) and shock wave application (focused vs. radial). Since it is not possible to disintegrate stones with these devices, the term “lithotripter” seems to be inappropriate.
This study included 76 patients (52.8 11.7 years) treated by Omnispec ED1000 Medispec (electrohydraulic, focused) applying 12 sessions over 9 weeks) and 484 patients (52.5 11.6 years) treated by Renova Direx (electromagnetic, radial) applying 4 sessions over 4 weeks.
The treatment template of the electrohydraulic device (ED1000) was 3000 shockwaves delivered (energy density = 0.09 mJ/mm2, frequency = 5 Hz) to three sites along the penile shaft and two sites at the penile crural levels fol-lowing a treatment protocol consisting of one treatment session per week for 3 weeks, a no-treatment interval of 3 weeks, and again, one treatment session per week for 3 weeks. Thus, treatment with this device requires as many as 9 weeks and 12 sessions. In contrast, the treatment protocol of the electromagnetic lithotripter with linear shock-wave technology (Renova) was dramatically different as it consisted of only 4 weekly sessions of 3600 shocks (energy density = 0.09 mJ/mm2, frequency = 5 Hz).
The 76 male patients had undergone Li-ESWT with the ED1000 from August 2010 to May 2018 and the 484 male patients had undergone LiESWT with Renova from June 2018 to January 2022. So it was a consecutive series.
All patients complained of some level of problem with erections. Age and sexual symptoms were evaluated by several specific questionnaires including the Sexual Health Inventory for Men (SHIM), the Erection Hardness Score (EHS), and the sexual subscore of the Aging Males Symptoms rating scale (AMS). The blood examinations included fasting blood sugar, triglyceride, cortisol, and total testosterone.
Sexual symptom scores were improved significantly by both lithotripters, although the changes in the scores did not differ significantly between them. Efficacy rate as judged by patient satisfaction was 65.8% with the ED1000 and 71.1% with Renova, also without significant difference. Among several factors including age, sexual symptoms scores, endocrinological factors, metabolic factors, and the rate of phosphodiesterase type 5 inhibitor use, only age was found to be an independent factor influencing the efficacy of Renova with significant decrease of efficacy in patients above 70 years.
Obviously, the study confirms the efficacy of Li-ESWT independent from the mode of shock wave generation and application. This is in accordance with previous studies. However, based on the retrospective design of the study, the authors cannot draw more conclusions. The protocol they used for the electrohydraulic focused shock wave therapy differs significantly dates back to 2010 and differs significantly from recent protocols applying 6 sessions of Li-ESWT over 6 weeks. Such protocols proved to be also very effective. The authors could have used also such protocols. However, after 2018 they only used the electromagnetic radial device. Based on their results it might be now interesting to use a similar protocol with devices applying focused shock waves (ie. Storz-Medical Duolith, Elevasion Piezowave 2). Also, elderly patients may need more treatments.
Nevertheless, I do not support the conclusion of the authors indicating any advantage of the electromagnetic radial shock wave device of the electrohydraulic focusing device. Obviously, the authors only “speculated” about such advantages. This paper clearly shows, that we need further randomized controlled studies on this topic.

Jens Rassweiler

This is a retrospective study comparing the outcome of Li-ESWT using two different devices (“lithotripters”) with different principles of shock wave generation (electrohydraulic vs. electromagnetic) and shock wave application (focused vs. radial). Since it is not possible to disintegrate stones with these devices, the term “lithotripter” seems to be inappropriate. This study included 76 patients (52.8 11.7 years) treated by Omnispec ED1000 Medispec (electrohydraulic, focused) applying 12 sessions over 9 weeks) and 484 patients (52.5 11.6 years) treated by Renova Direx (electromagnetic, radial) applying 4 sessions over 4 weeks. The treatment template of the electrohydraulic device (ED1000) was 3000 shockwaves delivered (energy density = 0.09 mJ/mm2, frequency = 5 Hz) to three sites along the penile shaft and two sites at the penile crural levels fol-lowing a treatment protocol consisting of one treatment session per week for 3 weeks, a no-treatment interval of 3 weeks, and again, one treatment session per week for 3 weeks. Thus, treatment with this device requires as many as 9 weeks and 12 sessions. In contrast, the treatment protocol of the electromagnetic lithotripter with linear shock-wave technology (Renova) was dramatically different as it consisted of only 4 weekly sessions of 3600 shocks (energy density = 0.09 mJ/mm2, frequency = 5 Hz). The 76 male patients had undergone Li-ESWT with the ED1000 from August 2010 to May 2018 and the 484 male patients had undergone LiESWT with Renova from June 2018 to January 2022. So it was a consecutive series. All patients complained of some level of problem with erections. Age and sexual symptoms were evaluated by several specific questionnaires including the Sexual Health Inventory for Men (SHIM), the Erection Hardness Score (EHS), and the sexual subscore of the Aging Males Symptoms rating scale (AMS). The blood examinations included fasting blood sugar, triglyceride, cortisol, and total testosterone. Sexual symptom scores were improved significantly by both lithotripters, although the changes in the scores did not differ significantly between them. Efficacy rate as judged by patient satisfaction was 65.8% with the ED1000 and 71.1% with Renova, also without significant difference. Among several factors including age, sexual symptoms scores, endocrinological factors, metabolic factors, and the rate of phosphodiesterase type 5 inhibitor use, only age was found to be an independent factor influencing the efficacy of Renova with significant decrease of efficacy in patients above 70 years. Obviously, the study confirms the efficacy of Li-ESWT independent from the mode of shock wave generation and application. This is in accordance with previous studies. However, based on the retrospective design of the study, the authors cannot draw more conclusions. The protocol they used for the electrohydraulic focused shock wave therapy differs significantly dates back to 2010 and differs significantly from recent protocols applying 6 sessions of Li-ESWT over 6 weeks. Such protocols proved to be also very effective. The authors could have used also such protocols. However, after 2018 they only used the electromagnetic radial device. Based on their results it might be now interesting to use a similar protocol with devices applying focused shock waves (ie. Storz-Medical Duolith, Elevasion Piezowave 2). Also, elderly patients may need more treatments. Nevertheless, I do not support the conclusion of the authors indicating any advantage of the electromagnetic radial shock wave device of the electrohydraulic focusing device. Obviously, the authors only “speculated” about such advantages. This paper clearly shows, that we need further randomized controlled studies on this topic. Jens Rassweiler
Sunday, 03 March 2024