Introduction: Extracorporeal shock wave therapy (ESWT) for erectile dysfunction (ED) presents a challenging paradox. While numerous clinical studies, systematic reviews, and meta-analyses have been published, indicating a substantial body of evidence supporting the efficacy and safety of ESWT, significant questions remain. Notably, the American Urological Association (AUA) continues to classify ESWT for ED as investigational (Evidence Level: Grade C), suggesting that the true therapeutic effect of ESWT may differ considerably from current estimates. This review aims to critically assess the evidence and propose strategies to address this unresolved discrepancy. Data sources: We systematically searched two electronic databases (PubMed and Ovid/Embase) and published systematic reviews on ESWT for ED and compiled a systematic literature review and meta-analysis based on 87 relevant studies. Areas of agreement: There is clear evidence that ESWT for ED is effective and can therefore be a valuable treatment modality in the management of ED. Areas of controversy: Current assessments of ESWT for ED as investigational by, e.g., the AUA may not stem from a lack of clinical studies, insufficient related basic science, or an inadequate number of systematic reviews and meta-analyses. Instead, the deficits lie in the area of the scientific quality of the clinical studies published to date. Growing points: We hypothesize that this unfortunate situation will only change if the following aspects will be rigorously considered in future clinical studies on ESWT for ED: adequate characterization and reporting of extracorporeal shock waves, appropriate handling of missing data and intercurrent events, and comprehensive classification of ESWT in the overall context of the available treatment options for ED. Areas for developing research: We are convinced that the consistent implementation of these aspects will significantly contribute to establishing ESWT as the first truly regenerative therapy in the management of ED. This overall aim justifies the corresponding efforts, for the benefit of our patients.

JD serves as speaker for the Swiss Urology Academy, owned by Electro Medical Systems S.A. (Nyon, Switzerland). Electro Medical Systems is the manufacturer and distributor of the Swiss DolorClast and PiezoClast devices mentioned in this article. EH is President of the French College of Sexology and Sexual Medicine and is in charge of the Andrology and Sexual Medicine Committee of the French Association of Urology. GM is a Director for Harley Street Shockwave and Rejuvenation Clinic Limited and is the Coordinator for the British Shockwave and Rejuvenation Association. CS has served as Consultant for Electro Medical Systems. However, Electro Medical Systems had no role in study design, data collection, and analysis, interpretation of the data, and no role in the decision to publish and write this manuscript. No other potential conflicts of interest relevant to this article were reported.

This study did not receive any funding.

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