Schuh MF. et al., 2025: Shock Wave Therapy in the Treatment of Erection Dysfunction: How to Define Clinical Outcomes? A Comparison Between Penile Doppler Ultrasound and a New Visual Erec-tion Hardness Score (V-EHS) During a Blinded, Sham-Controlled Trial.

Thursday, 03 July 2025

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Mathias Ferreira Schuh 1, Rodrigo Ribeiro Vieiralves 1, Luciano Alves Favorito 1 2
1Departamento de Urologia, Lagoa Federal Hospital, Rio de Janeiro, RJ, Brasil.
2Unidade de Pesquisa Urogenital, Universidade do Estado do Rio de Janeiro, UERJ, Rio de Janeiro, RJ, Brasil.

Abstract

Background: In the last decade, several studies have proven the effectiveness of low-intensity shock waves (LI-ESWT), but with several factors that make it difficult to carry out systematic reviews.

Aim: To demonstrate the effectiveness of LI-ESWT and define the best tool for routine clinical assessment of erectile dysfunction.

Materials and methods: Twenty-one participants with purely vasculogenic erectile dysfunction were selected and randomized to LI-ESWT or placebo. All patients underwent evaluation with The International Index of Erectile Function (IIEF-5), V-EHS (new visual scale), and standardized penile doppler ultrasound before and after shock wave therapy.

Outcomes: LI-ESWT has proven effective in the treatment of moderate erectile dysfunction, and the new V-EHS has demonstrated greater accuracy than Doppler in the diagnosis and follow-up of erectile dysfunction.

Results: Using the IIEF-5 as a control tool, we observed a clinical response after 1 month, with a greater increase in the shock wave therapy arm of +3.21 points compared to + 0.57 in the sham group. At six months, the treated group showed a mean increase of 4.71 points compared to baseline (p = 0.006), while those who received sham therapy had a decrease (case = +4.71 points vs. sham control = -1.0, p = 0.006). Based on this observed difference, we performed a comparative analysis between the V-EHS and penile doppler ultrasound to observe whether the test results corroborated the IIEF-5 findings. The correlation between V-EHS and IIEF-5 in the therapy group in the pre-therapy period was strong (r = 0.816, p < 0.001), and at 6 months it increased to very strong (r = 0.928, p < 0.001). Penile Doppler ultrasound did not show the same correlation strength with IIEF-5, presenting a moderate correlation at 6 months (Pearson correlation score = 0.540), as also demonstrated in the ROC curve through the V-EHS AUC = 0.963 (p = 0.001) vs. Doppler AUC = 0.713 (p = 0,290). Strengths and Limitations: The main strengths of the present study are the blinded, randomized, placebo-controlled clinical trial and the comparison between penile Doppler and a new visual classification for erection hardness score. The limitations are the number of patients and the short follow-up.

Conclusions: LI-ESWT has proven effective in the treatment of moderate vasculogenic erectile dysfunction, with optimal results at 6 months. The new V-EHS offers a simple, reliable and reproducible assessment of erectile function.

Int Braz J Urol. 2025 Mar-Apr;51(2):e20249927. doi: 10.1590/S1677-5538.IBJU.2024.9927.
PMID: 39913097

Comments 1

Jens Rassweiler on Thursday, 03 July 2025 11:00

Background: Erectile dysfunction (ED) affects approximately 18 million men in the U.S., significantly impacting their quality of life. Low-intensity extracorporeal shock wave therapy (LI-ESWT) has emerged as an effective treatment, particularly for men with mild to moderate vasculogenic ED. This therapy aims to repair erectile tissue, improve penile hemodynamics, and promote neovascularization. Despite its potential, the lack of standardization in assessment methodologies complicates the evaluation of treatment efficacy.

Objectives: The study aimed to evaluate the effectiveness of LI-ESWT on erectile function while comparing clinical outcomes using the International Index of Erectile Function (IIEF-5), penile Doppler ultrasound, and a new Visual Erection Hardness Score (V-EHS).

Methods:
- A two-arm, single-blinded, sham-controlled clinical trial was conducted from June 2022 to March 2024.
- Patients were selected based on the presence of moderate ED, confirmed through IIEF-5 and Doppler ultrasound. Participants were randomized into two groups: one receiving LI-ESWT and the other a sham treatment, with both groups monitored at 1, 3, and 6 months post-treatment. LI-ESWT involved 12 sessions over six weeks.

Results: A total of 21 patients completed the study, with significant improvements seen in the LI-ESWT group compared to the sham group, particularly at the 3-month and 6-month follow-ups.The IIEF-5 scores increased from 14.29 before treatment to 19.00 at 6 months in the treatment group, while the sham group showed a decline. Strong correlations between IIEF-5 and V-EHS were noted, indicating V-EHS may serve as a more reliable predictor of erectile function compared to the penile Doppler metrics, which showed lower correlations.

Discussion: The findings support LI-ESWT as an effective treatment for mild to moderate vasculogenic ED, demonstrating significant clinical improvements. The V-EHS was found to be a superior predictor of treatment response compared to penile Doppler ultrasound, being simpler and more easily applicable in clinical settings.The study acknowledged the limitations of a small sample size and the necessity for more rigorous standardization across future research.

Conclusions:
LI-ESWT effectively treats mild to moderate vasculogenic ED, with the V-EHS presenting as a practical, reliable tool for assessing treatment outcomes. The study emphasizes the need for standardized treatment protocols and validation of assessment tools to enhance the applicability and comparability of findings in subsequent research. It is also interesting, that a better vascular supply does not guarantee better erectile function.

Jens Rassweiler

Objectives: The study aimed to evaluate the effectiveness of LI-ESWT on erectile function while comparing clinical outcomes using the International Index of Erectile Function (IIEF-5), penile Doppler ultrasound, and a new Visual Erection Hardness Score (V-EHS).

Methods:
- A two-arm, single-blinded, sham-controlled clinical trial was conducted from June 2022 to March 2024.
- Patients were selected based on the presence of moderate ED, confirmed through IIEF-5 and Doppler ultrasound. Participants were randomized into two groups: one receiving LI-ESWT and the other a sham treatment, with both groups monitored at 1, 3, and 6 months post-treatment. LI-ESWT involved 12 sessions over six weeks.
	[img]https://www.storzmedical.com/images/blog/Schuh.PNG[/img]
Results: A total of 21 patients completed the study, with significant improvements seen in the LI-ESWT group compared to the sham group, particularly at the 3-month and 6-month follow-ups.The IIEF-5 scores increased from 14.29 before treatment to 19.00 at 6 months in the treatment group, while the sham group showed a decline. Strong correlations between IIEF-5 and V-EHS were noted, indicating V-EHS may serve as a more reliable predictor of erectile function compared to the penile Doppler metrics, which showed lower correlations.

Discussion: The findings support LI-ESWT as an effective treatment for mild to moderate vasculogenic ED, demonstrating significant clinical improvements. The V-EHS was found to be a superior predictor of treatment response compared to penile Doppler ultrasound, being simpler and more easily applicable in clinical settings.The study acknowledged the limitations of a small sample size and the necessity for more rigorous standardization across future research.

Conclusions:
LI-ESWT effectively treats mild to moderate vasculogenic ED, with the V-EHS presenting as a practical, reliable tool for assessing treatment outcomes. The study emphasizes the need for standardized treatment protocols and validation of assessment tools to enhance the applicability and comparability of findings in subsequent research. It is also interesting, that a better vascular supply does not guarantee better erectile function.

Jens Rassweiler

Background: Erectile dysfunction (ED) affects approximately 18 million men in the U.S., significantly impacting their quality of life. Low-intensity extracorporeal shock wave therapy (LI-ESWT) has emerged as an effective treatment, particularly for men with mild to moderate vasculogenic ED. This therapy aims to repair erectile tissue, improve penile hemodynamics, and promote neovascularization. Despite its potential, the lack of standardization in assessment methodologies complicates the evaluation of treatment efficacy. Objectives: The study aimed to evaluate the effectiveness of LI-ESWT on erectile function while comparing clinical outcomes using the International Index of Erectile Function (IIEF-5), penile Doppler ultrasound, and a new Visual Erection Hardness Score (V-EHS). Methods: - A two-arm, single-blinded, sham-controlled clinical trial was conducted from June 2022 to March 2024. - Patients were selected based on the presence of moderate ED, confirmed through IIEF-5 and Doppler ultrasound. Participants were randomized into two groups: one receiving LI-ESWT and the other a sham treatment, with both groups monitored at 1, 3, and 6 months post-treatment. LI-ESWT involved 12 sessions over six weeks. [img]https://www.storzmedical.com/images/blog/Schuh.PNG[/img] Results: A total of 21 patients completed the study, with significant improvements seen in the LI-ESWT group compared to the sham group, particularly at the 3-month and 6-month follow-ups.The IIEF-5 scores increased from 14.29 before treatment to 19.00 at 6 months in the treatment group, while the sham group showed a decline. Strong correlations between IIEF-5 and V-EHS were noted, indicating V-EHS may serve as a more reliable predictor of erectile function compared to the penile Doppler metrics, which showed lower correlations. Discussion: The findings support LI-ESWT as an effective treatment for mild to moderate vasculogenic ED, demonstrating significant clinical improvements. The V-EHS was found to be a superior predictor of treatment response compared to penile Doppler ultrasound, being simpler and more easily applicable in clinical settings.The study acknowledged the limitations of a small sample size and the necessity for more rigorous standardization across future research. Conclusions: LI-ESWT effectively treats mild to moderate vasculogenic ED, with the V-EHS presenting as a practical, reliable tool for assessing treatment outcomes. The study emphasizes the need for standardized treatment protocols and validation of assessment tools to enhance the applicability and comparability of findings in subsequent research. It is also interesting, that a better vascular supply does not guarantee better erectile function. Jens Rassweiler

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