Extracorporeal shock wave therapy for erectile dysfunction: rethinking study design, implementation, and analysis.

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.

Source of data: 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 are 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 timely 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.