Desai Janak, Huyghe Eric, Maffulli Gayle D, Nussbaum-Krammer Carmen, Tittelmeier Jessica, Schmitz Christoph
Department of Urology, Samved Hospital, 100, Commerce Six Rd, Swastik Society, Navrangpura, Ahmedabad, Gujarat 380014, India.
Department of Reproductive Medicine, Paule-de-Viguier Hospital, Toulouse University Hospital, 330 Av. de Grande Bretagne, 31300 Toulouse, France.
Br Med Bull. 2025 Apr 4;154(1). doi: 10.1093/bmb/ldaf004.
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.
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.
There is clear evidence that ESWT for ED is effective and can therefore be a valuable treatment modality in the management of ED.
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.
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.
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.
用于治疗勃起功能障碍（ED）的体外冲击波疗法（ESWT）存在一个具有挑战性的矛盾现象。尽管已经发表了大量临床研究、系统评价和荟萃分析，表明有大量证据支持ESWT的有效性和安全性，但仍存在重大问题。值得注意的是，美国泌尿外科学会（AUA）继续将用于ED的ESWT归类为研究性治疗（证据级别：C级），这表明ESWT的真正治疗效果可能与当前估计有很大差异。本综述旨在严格评估证据，并提出解决这一未解决差异的策略。
我们系统检索了两个电子数据库（PubMed和Ovid/Embase），并发表了关于ESWT治疗ED的系统评价，基于87项相关研究进行了系统文献综述和荟萃分析。
有明确证据表明ESWT治疗ED是有效的，因此可以成为ED管理中有价值的治疗方式。
目前如AUA等将用于ED的ESWT评估为研究性治疗，可能并非源于临床研究不足、相关基础科学不够或系统评价和荟萃分析数量不足。相反，缺陷在于迄今为止发表的临床研究的科学质量方面。
我们假设，只有在未来关于ESWT治疗ED的临床研究中严格考虑以下方面，这种不利情况才会改变：对体外冲击波进行充分的特征描述和报告、对缺失数据和并发事件进行适当处理，以及在ED可用治疗选择的整体背景下对ESWT进行全面分类。
我们相信，这些方面的一致实施将显著有助于将ESWT确立为ED管理中的首个真正的再生疗法。这一总体目标证明了为我们的患者利益而做出的相应努力是合理的。
