22 Guideline status Major guidelines take the same cautious but open posture, and they diverge: • The European Association of Urology accepts that Li-ESWT may be used in men with mild organic (vasculogenic) ED, or as an option in poor responders to PDE5 inhibitors, but assigns a weak strength of [14] recommendation . • The American Urological Association classies Li-ESWT as investigational for ED, a conditional recommendation graded C, which reects low to very low [15] condence in the evidence . No major guideline positions the therapy as rst-line. A clinician citing “the guidelines” should be specic about which body and which recommendation strength they mean. Limitations and future directions Three gaps dene the research agenda. First, durability: several datasets show benet fading by 9 to 12 months, and re-treatment intervals are undened. Second, standardisation: until device and protocol parameters are harmonised, "shockwave therapy" in one trial cannot be assumed equivalent to another. Third, trial quality and independence: the eld needs betterpowered, longer, protocol-consistent and independently funded studies, particularly in the harder-to-treat neurogenic and postsurgical populations. Until these are addressed, conclusions should remain measured. Conclusion Low-intensity shockwave therapy has earned a dened, if limited, place in the management of erectile dysfunction. Its restorative rationale is biologically coherent, and the randomised evidence supports a real treatment effect in carefully selected men with mild-to-moderate vasculogenic ED, including some PDE5i poor responders, in whom combination with a daily PDE5i appears to improve outcomes. That effect is modest, of uncertain durability, and supported by evidence of low overall certainty. The therapy is well tolerated and low risk, which strengthens its case as an option for the informed patient, but it is not a cure and not a rst-line replacement for established therapy. Used selectively and described honestly, as vascular remodelling with nite, individual benet, Li-ESWT is a reasonable addition to the ED armamentarium. Oversold as a cure, it risks squandering the credibility of a promising approach. Declarations Conicts of interest: The author declares no conicts of interest. The author has no nancial relationship with, and has received no funding, equipment or support from, any manufacturer or distributor of shockwave therapy devices. Funding: This work received no specic funding. References 1. Sokolakis I, Dimitriadis F, Teo P, Hatzichristodoulou G, Hatzichristou D, Giuliano F. The basic science behind low-intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic scoping review of pre-clinical studies. J Sex Med. 2019;16(2):168-194. https://doi.org/10.1016/j.jsxm.2018.12.016 2. Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low-intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. Eur Urol. 2012;61(1):149-156. https://doi.org/10.1016/j.eururo.2011.07.054 3. Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of low-intensity extracorporeal shockwave therapy on erectile dysfunction: a systematic review and metaanalysis. J Sex Med. 2017;14(1):27-35. https://doi.org/10.1016/j.jsxm.2016.11.001 4. Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity extracorporeal shock wave treatment improves erectile function: a systematic review and meta-analysis. Eur Urol. 2017;71(2):223233. https://doi.org/10.1016/j.eururo.2016.05.050 5. Man L, Li G. Low-intensity extracorporeal shock wave therapy for erectile dysfunction: a systematic review and meta-analysis. Urology. 2018;119:97-103. https://doi.org/10.1016/j.urology.2017.09.011 6. Yao H, Wang X, Liu H, Sun F, Tang G, Bao X, et al. Systematic review and meta-analysis of 16 randomized controlled trials of clinical outcomes of low-intensity extracorporeal shock wave therapy in treating erectile dysfunction. Am J Mens Health.2022;16(2):15579883221087532. https://doi.org/10.1177/15579883221087532 7. Kalyvianakis D, Mykoniatis I, Pyrgidis N, Memmos E, Hatzichristou D. Clinical studies on low intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic review and meta-analysis of randomised controlled trials. Int J Impot Res. 2019;31(3):177-194. https://doi.org/10.1038/s41443019-0117-z 8. Fatima M, et al. Efcacy of low-intensity extracorporeal shockwave therapy for erectile dysfunction: an updated systematic review and meta-analysis of randomised controlled trials. Future Sci OA. 2025.
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