Saitta G. et al., 2026: Low-intensity extracorporeal shock wave therapy in vasculogenic erectile dysfunction refractory to PDE5 inhibitors: a prospective study with 12- and 18-month outcomes.

Saitta G, Di Paola G, Di Salvatore S, Calabrese B, Ceresoli AS, Mantovani F, Meazza AL, Seveso M.
Arch Ital Urol Androl. 2026 Mar 2:14707. doi: 10.4081/aiua.2026.14707

Abstract

Background: Low-intensity extracorporeal shock wave therapy (Li-ESWT) has emerged as a promising treatment for vasculogenic erectile dysfunction (ED), particularly in men who do not respond to phosphodiesterase type-5 inhibitors (PDE5-Is).

Objective: To evaluate the feasibility, safety, and clinical effectiveness of Li-ESWT in men with vasculogenic ED through a prospective 12- and 18-month follow-up.

Methods: A prospective observational study was conducted on 188 patients with vasculogenic ED and inadequate response to PDE5-Is. Patients underwent 6 weekly sessions of Li-ESWT. Erectile function was assessed using the international index of erectile function (IIEF) and erection hardness score (EHS). Responders were defined as those achieving ≥ 3-point improvement on IIEF-EF and/or EHS ≥3.

Results: Mean age was 66.6 years; mean ED duration was 24 months. IIEF-EF improved from 11 at baseline to 21 at 12 months and 18 at 18 months. At 12 months, 71% of patients showed improvement in EHS. Younger age (<45 years), shorter ED duration (<12 months), and moderate baseline severity predicted better response (p<0.05). Sustained improvement was observed in 65% of patients at 12 months and 54% at 18 months. No adverse events were reported.

Conclusions: Li-ESWT is a safe and effective treatment for vasculogenic ED unresponsive to PDE5-Is, with maximum benefit observed within 12 months. Efficacy tends to decline at 18 months. Larger controlled studies are needed to define long-term outcomes.

Comment Jens Rassweiler

This article discusses a prospective study investigating the effectiveness of low-intensity extracorporeal shock wave therapy (Li-ESWT) for treating vasculogenic erectile dysfunction (ED) in men who do not respond to phosphodiesterase type-5 inhibitors (PDE5-Is). Li-ESWT has gained attention as a potential treatment for ED, particularly for cases that are resistant to conventional pharmacological treatments like PDE5-Is. This study aimed to assess the feasibility, safety, and clinical effectiveness of Li-ESWT in men with vasculogenic ED through follow-up assessments at 12 and 18 months.

Material and Methods

188 men diagnosed with vasculogenic ED and inadequate response to PDE5-Is were enrolled. Participants underwent 6 weekly sessions of Li-ESWT, receiving a total of 3000 shocks per session using an electrohydraulic shock wave generator, with an energy flux density ranging from 0.10 to 0.15 mJ/mm² and a frequency of 120 shocks per minute (2 Hz).

Assessment Tools: The International Index of Erectile Function (IIEF) and Erection Hardness Score (EHS) were used to evaluate erectile function.

Results

  Mean IIEF score improved significantly from 11 at baseline to 21 at 12 months and decreased to 18 at 18 months.

  71% of patients showed improvement in EHS at 12 months, with 65% of patients sustaining improvements at 12 months and 54% at 18 months.

Younger age (<45 years), shorter ED duration (<12 months), and moderate baseline severity were associated with better treatment outcomes.

No adverse events were reported, indicating a favorable safety profile for Li-ESWT.

Discussion

Clinical Implications

The study provides valuable evidence supporting the use of Li-ESWT as a non-invasive treatment option for men with ED who do not respond to traditional treatments. This could be particularly beneficial for patients who prefer to avoid invasive procedures or who are unable to tolerate PDE5-Is.

Biological Mechanisms

   - The article discusses potential mechanisms behind the efficacy of Li-ESWT, including neovascularization, endothelial repair, and nerve regeneration in penile tissues. This regenerative capacity highlights the therapy’s role not only in managing symptoms but also in potentially addressing underlying vascular issues. Herein, the role of mechanotransduction to stimulate stemcells of the corpora cavernosa should be also taken into consideration.

Long-term Efficacy

 While significant improvements were observed initially, the decline in efficacy at 18 months raises questions about the long-term sustainability of the treatment benefits. This underscores the need for ongoing management and potentially combining Li-ESWT with other therapies to enhance and prolong its effects. A longer follow-up, eventually with re-treatment / maintenance therapy should be taken into consideration for future studies.

Predictors of Treatment Success

The identification of younger age and shorter duration of ED as predictors of positive outcomes suggests that timely intervention is crucial. This finding emphasizes the importance of early diagnosis and treatment of ED, potentially leading to better patient outcomes.

Study Limitations

The study's observational nature and lack of a control group limit the ability to draw definitive causal conclusions. Future randomized controlled trials with larger sample sizes and longer follow-up periods are necessary to validate these findings and refine treatment protocols.

Future Directions

 The article suggests exploring combination therapies, such as Li-ESWT with PDE5-Is or biological treatments, to improve therapeutic outcomes. Further research is needed to establish standardized treatment protocols and optimal patient selection criteria.

Conclusions

Li-ESWT is an effective and safe treatment for men with vasculogenic ED unresponsive to PDE5-Is. Significant improvements were noted at 12 months, with some decline by 18 months. The study suggests that early intervention may lead to better outcomes However, further research is necessary to address the limitations of the current study and to optimize treatment strategies for this patient population.

Jens Rassweiler