Lange M. et al., 2024: Is low-intensity shockwave therapy for erectile dysfunction a durable treatment option?-long-term outcomes of a randomized sham-controlled trial.

Wednesday, 12 February 2025

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Moritz Lange 1, David Charles 1, Aisha Kazeem 1, Marieke Jones 2, Fionna Sun 1, Soutik Ghosal 2, Sarah Krzastek 3, David Rapp 1, Nicolas Ortiz 1, Ryan Smith 1
1Department of Urology, University of Virginia, Charlottesville, VA, USA.
2Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.
3Division of Urology, Department of Surgery, Virginia Commonwealth University, Richmond, VA, USA.

Abstract

Background: Low-intensity shockwave therapy (LiSWT) is an emerging non-invasive and restorative therapy for erectile dysfunction (ED) with demonstrated efficacy and few adverse events. Although LiSWT has been shown to improve erectile function amongst men with ED, few studies have examined its long-term durability. We present the long-term results of a randomized controlled trial (RCT) assessing erectile function after LiSWT.

Methods: A total of 30 patients with baseline ED seen at the University of Virginia were randomized to LiSWT or sham treatment. Patients in the sham group crossed over at 1 month and were unblinded. After initial trial completion, patients enrolled in the long-term outcome study were considered one combined cohort. Patients were treated twice weekly for 3 consecutive weeks with a Storz® Duolith™ device delivering 3,000 shockwaves at 0.1 mJ/mm2 to the distal penis, the base of the penis, and the crura. Primary outcomes were changes in Sexual Health Inventory for Men (SHIM) and Erection Hardness Score (EHS) from baseline (3 months pre-treatment) up to 36 months post-treatment. Changes in SHIM and EHS scores were evaluated using linear mixed effects models. Patient satisfaction was assessed with the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index.

Results: The mean baseline SHIM score was 10.8±0.94. At 12-, 24-, and 36-month assessment following treatment, the mean SHIM scores were 15.6±1.27 (P<0.001), 15.0±1.14 (P<0.001), and 12.2±1.43 (P=0.31). The mean baseline EHS score was 1.87±0.17. At 12-, 24-, and 36-month assessment following treatment, the mean EHSs were 2.70±0.24 (P<0.001), 2.66±0.21 (P<0.001), and 2.29±0.26 (P=0.10). The median [interquartile range (IQR)] EDITS score was 48.9 (22.7, 74.4), indicating moderate satisfaction with LiSWT. There were no adverse events recorded.

Conclusions: Our analysis demonstrates sustained long-term improvement in erectile function after LiSWT for a heterogeneous cohort. While limited by population size, the results suggest durable improvement in erectile function for the first 2 years with a peak treatment effect at 1 year. Treatment effect appears to decline between 2 and 3 years.

Transl Androl Urol. 2024 Oct 31;13(10):2194-2200. doi: 10.21037/tau-24-329. Epub 2024 Oct 28.
PMID: 39507860 FREE PMC ARTICLE

Comments 1

Jens Rassweiler on Wednesday, 12 February 2025 10:00

The article explores the long-term outcomes of low-intensity shockwave therapy (LiSWT) for erectile dysfunction (ED) based on a randomized sham-controlled trial. The study highlights the increasing prevalence of ED, particularly vasculogenic ED, and discusses the emergence of LiSWT as a viable treatment option that aims to address the underlying pathology rather than just providing symptomatic relief. Although LiSWT has shown short-term efficacy in improving erectile function, the study aims to evaluate its durability over a longer follow-up period of up to 36 months.

The methodology involved randomizing patients with mild to moderate ED to receive either LiSWT or sham treatment, with follow-up assessments of erectile function using the Sexual Health Inventory for Men (SHIM) scores and Erection Hardness Scores (EHS) at various intervals post-treatment. The device used for low-intensity shockwave therapy (LiSWT) in the study was the Storz® Duolith™ device (Storz Medical AG, Tägerwilen, Switzerland). The treatment parameters included delivering 3,000 shockwaves at an energy density of 0.1 mJ/mm² per session. Patients received treatment twice weekly for three consecutive weeks, totaling six sessions. The therapy targeted the distal penis, the base of the penis, and the crura.

Results indicated significant improvements in both SHIM and EHS scores up to 24 months after treatment, with maximum improvement observed at the 12-month mark. However, there was a noted decline in erectile function at the 36-month follow-up, suggesting a plateau effect after the initial benefits. The study provided specific data regarding the changes in SHIM scores and Erection Hardness Scores (EHS) at various follow-up points. The estimated marginal mean SHIM scores were as follows:
• Baseline: 10.8 (95% CI: 8.95, 12.7)
• 12 months: 15.6 (95% CI: 13.07, 18.1)
• 24 months: 15.0 (95% CI: 12.79, 17.3)
• 36 months: 12.2 (95% CI: 9.38, 15.0)
These scores showed statistically significant improvements at 12 and 24 months compared to baseline (P kleiner 0.05), but the improvement was not statistically significant at 36 months (P=0.31).

For the EHS, the estimated marginal means were:
• Baseline: 1.87 (95% CI: 1.53, 2.21)
• 12 months: 2.70 (95% CI: 2.23, 3.17)
• 24 months: 2.66 (95% CI: 2.24, 3.07)
• 36 months: 2.29 (95% CI: 1.77, 2.82)
Similar to the SHIM scores, EHS showed significant improvements at 12 and 24 months but was not statistically significant at 36 months (P=0.10).

The discussion addresses the variability in treatment responses and the challenges of directly comparing different studies due to heterogeneity in treatment protocols. It also proposes the potential benefits of repeated LiSWT courses for patients experiencing a decline in function. Overall, the findings suggest that while LiSWT provides substantial benefits for up to two years, further research is necessary to optimize treatment protocols and understand the long-term efficacy of LiSWT for ED. Based on these results a maintenance therapy (ie. after 24 months) might be useful.

Maintenance therapy with low-intensity extracorporeal shockwave therapy (Li-ESWT) could be a valuable approach for sustaining the improvements in erectile function observed after initial treatment. Given the study's findings indicating a plateau in efficacy and a decline in erectile function at around 36 months, maintenance therapy could help to prolong the benefits achieved during the initial treatment phase. Regular follow-up sessions may reinforce the positive effects of Li-ESWT, potentially enhancing tissue health and maintaining vascular function over time.

Jens Rassweiler

The methodology involved randomizing patients with mild to moderate ED to receive either LiSWT or sham treatment, with follow-up assessments of erectile function using the Sexual Health Inventory for Men (SHIM) scores and Erection Hardness Scores (EHS) at various intervals post-treatment. The device used for low-intensity shockwave therapy (LiSWT) in the study was the Storz® Duolith™ device (Storz Medical AG, Tägerwilen, Switzerland). The treatment parameters included delivering 3,000 shockwaves at an energy density of 0.1 mJ/mm² per session. Patients received treatment twice weekly for three consecutive weeks, totaling six sessions. The therapy targeted the distal penis, the base of the penis, and the crura.

Results indicated significant improvements in both SHIM and EHS scores up to 24 months after treatment, with maximum improvement observed at the 12-month mark. However, there was a noted decline in erectile function at the 36-month follow-up, suggesting a plateau effect after the initial benefits. The study provided specific data regarding the changes in SHIM scores and Erection Hardness Scores (EHS) at various follow-up points. The estimated marginal mean SHIM scores were as follows: 
•	Baseline: 10.8 (95% CI: 8.95, 12.7)
•	12 months: 15.6 (95% CI: 13.07, 18.1)
•	24 months: 15.0 (95% CI: 12.79, 17.3)
•	36 months: 12.2 (95% CI: 9.38, 15.0)
These scores showed statistically significant improvements at 12 and 24 months compared to baseline (P kleiner 0.05), but the improvement was not statistically significant at 36 months (P=0.31).

For the EHS, the estimated marginal means were:
•	Baseline: 1.87 (95% CI: 1.53, 2.21)
•	12 months: 2.70 (95% CI: 2.23, 3.17)
•	24 months: 2.66 (95% CI: 2.24, 3.07)
•	36 months: 2.29 (95% CI: 1.77, 2.82)
Similar to the SHIM scores, EHS showed significant improvements at 12 and 24 months but was not statistically significant at 36 months (P=0.10).

The discussion addresses the variability in treatment responses and the challenges of directly comparing different studies due to heterogeneity in treatment protocols. It also proposes the potential benefits of repeated LiSWT courses for patients experiencing a decline in function. Overall, the findings suggest that while LiSWT provides substantial benefits for up to two years, further research is necessary to optimize treatment protocols and understand the long-term efficacy of LiSWT for ED. Based on these results a maintenance therapy (ie. after 24 months) might be useful.

Maintenance therapy with low-intensity extracorporeal shockwave therapy (Li-ESWT) could be a valuable approach for sustaining the improvements in erectile function observed after initial treatment. Given the study's findings indicating a plateau in efficacy and a decline in erectile function at around 36 months, maintenance therapy could help to prolong the benefits achieved during the initial treatment phase. Regular follow-up sessions may reinforce the positive effects of Li-ESWT, potentially enhancing tissue health and maintaining vascular function over time.

Jens Rassweiler

The article explores the long-term outcomes of low-intensity shockwave therapy (LiSWT) for erectile dysfunction (ED) based on a randomized sham-controlled trial. The study highlights the increasing prevalence of ED, particularly vasculogenic ED, and discusses the emergence of LiSWT as a viable treatment option that aims to address the underlying pathology rather than just providing symptomatic relief. Although LiSWT has shown short-term efficacy in improving erectile function, the study aims to evaluate its durability over a longer follow-up period of up to 36 months. The methodology involved randomizing patients with mild to moderate ED to receive either LiSWT or sham treatment, with follow-up assessments of erectile function using the Sexual Health Inventory for Men (SHIM) scores and Erection Hardness Scores (EHS) at various intervals post-treatment. The device used for low-intensity shockwave therapy (LiSWT) in the study was the Storz® Duolith™ device (Storz Medical AG, Tägerwilen, Switzerland). The treatment parameters included delivering 3,000 shockwaves at an energy density of 0.1 mJ/mm² per session. Patients received treatment twice weekly for three consecutive weeks, totaling six sessions. The therapy targeted the distal penis, the base of the penis, and the crura. Results indicated significant improvements in both SHIM and EHS scores up to 24 months after treatment, with maximum improvement observed at the 12-month mark. However, there was a noted decline in erectile function at the 36-month follow-up, suggesting a plateau effect after the initial benefits. The study provided specific data regarding the changes in SHIM scores and Erection Hardness Scores (EHS) at various follow-up points. The estimated marginal mean SHIM scores were as follows: • Baseline: 10.8 (95% CI: 8.95, 12.7) • 12 months: 15.6 (95% CI: 13.07, 18.1) • 24 months: 15.0 (95% CI: 12.79, 17.3) • 36 months: 12.2 (95% CI: 9.38, 15.0) These scores showed statistically significant improvements at 12 and 24 months compared to baseline (P kleiner 0.05), but the improvement was not statistically significant at 36 months (P=0.31). For the EHS, the estimated marginal means were: • Baseline: 1.87 (95% CI: 1.53, 2.21) • 12 months: 2.70 (95% CI: 2.23, 3.17) • 24 months: 2.66 (95% CI: 2.24, 3.07) • 36 months: 2.29 (95% CI: 1.77, 2.82) Similar to the SHIM scores, EHS showed significant improvements at 12 and 24 months but was not statistically significant at 36 months (P=0.10). The discussion addresses the variability in treatment responses and the challenges of directly comparing different studies due to heterogeneity in treatment protocols. It also proposes the potential benefits of repeated LiSWT courses for patients experiencing a decline in function. Overall, the findings suggest that while LiSWT provides substantial benefits for up to two years, further research is necessary to optimize treatment protocols and understand the long-term efficacy of LiSWT for ED. Based on these results a maintenance therapy (ie. after 24 months) might be useful. Maintenance therapy with low-intensity extracorporeal shockwave therapy (Li-ESWT) could be a valuable approach for sustaining the improvements in erectile function observed after initial treatment. Given the study's findings indicating a plateau in efficacy and a decline in erectile function at around 36 months, maintenance therapy could help to prolong the benefits achieved during the initial treatment phase. Regular follow-up sessions may reinforce the positive effects of Li-ESWT, potentially enhancing tissue health and maintaining vascular function over time. Jens Rassweiler

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