https://doi.org/10.4081/aiua.2026.14707
Low-intensity extracorporeal shock wave therapy in vasculogenic erectile dysfunction refractory to PDE5 inhibitors: a prospective study with 12- and 18-month outcomes
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Published: 2 March 2026
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.
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1. Liu JL, Chu KY, Gabrielson AT, et al. Restorative therapies for erectile dysfunction: position statement from the Sexual Medicine Society of North America (SMSNA). Sex Med. 2021; 9:100343. DOI: https://doi.org/10.1016/j.esxm.2021.100343
2. Sârbu MI, Tampa M, Mitran MI. The current treatment of erectile dysfunction. J Mind Med Sci. 2016; 3:118-130. DOI: https://doi.org/10.22543/2392-7674.1054
3. Pellegrino F, Sjoberg DD, Tin AL, et al. Relationship between age, comorbidity, and the prevalence of erectile dysfunction. Eur Urol Focus. 2023; 9:162-167. DOI: https://doi.org/10.1016/j.euf.2022.08.006
4. Singhal A, Bhardwaj M, Bhardwaj G, et al. Low-intensity extracorporeal shock wave therapy (LI-ESWT) for erectile dysfunction in patients post-prostatectomy: a systematic review. Cureus 2025;17:e93901. DOI: https://doi.org/10.7759/cureus.93901
5. Atlantis E, Sullivan T. Bidirectional association between depression and sexual dysfunction: a systematic review and meta-analysis. J Sex Med. 2012; 9:1497-1507. DOI: https://doi.org/10.1111/j.1743-6109.2012.02709.x
6. European Association of Urology (EAU). EAU Guidelines on Sexual and Reproductive Health - Erectile Dysfunction (Internet). Available from: https://uroweb.org/guidelines/sexual-and-reproductive-health
7. Cai Z, Song X, Zhang J, et al. Practical approaches to treat ED in PDE5i nonresponders. Aging Dis. 2020; 11:1202-1218. DOI: https://doi.org/10.14336/AD.2019.1028
8. Huang SA, Lie JD. Phosphodiesterase 5 (PDE5) inhibitors in the management of erectile dysfunction. Phys Ther. 2013; 38:407:414-419.
9. Linet OI, Ogrinc FG. The Alprostadil Study Group. Efficacy and safety of intracavernosal alprostadil in men with erectile dysfunction. N Engl J Med. 1996; 334:873-877. DOI: https://doi.org/10.1056/NEJM199604043341401
10. Ramazan M, Øbro LF, Wiborg MH, et al. Complications of penile augmentation: a narrative review of injectables, implants, and surgical grafts. Int J Impot Res. 2025. DOI: https://doi.org/10.1038/s41443-025-01190-8
11. Raina R, Agarwal A, Ausmundson S, et al. Early use of vacuum constriction device following radical prostatectomy facilitates early sexual activity and potentially earlier return of erectile function. Int J Impot Res. 2006; 18:77-81. DOI: https://doi.org/10.1038/sj.ijir.3901380
12. Lewis RW, Witherington R. External vacuum therapy for erectile dysfunction: use and results. World J Urol. 1997; 15:78-82. DOI: https://doi.org/10.1007/BF01275162
13. Albaugh J, San Cheng L, Bergman J, et al. Adherence and barriers to penile rehabilitation over 2 years following radical prostatectomy: a pilot study. BJU Int. 2019; 123:853-860. DOI: https://doi.org/10.1186/s12894-019-0516-y
14. Yao WJ, Dong JT, Jiang TP, et al. Advances in erectile dysfunction treatment research: a narrative review. Transl Androl Urol. 2025; 14:2106-2117. doi:10.21037/tau-2025-193. DOI: https://doi.org/10.21037/tau-2025-193
15. Lu Z, Lin G, Reed Maldonado A, et al. Low-intensity extracorporeal shock wave treatment improves erectile function: a systematic review and meta-analysis. Eur Urol. 2017; 71:223-233. DOI: https://doi.org/10.1016/j.eururo.2016.05.050
16. Chawla ST, Shahan J, Soutipan N, et al. Radial type low-intensity extracorporeal shockwave therapy enhances penile microvascular perfusion in an aging rat model: a novel interventional strategy to treat erectile dysfunction. World J Mens Health. 2025; 43:396-406. DOI: https://doi.org/10.5534/wjmh.240032
17. Liu J, Zhou F, Li GY, et al. Evaluation of the effect of different doses of low-energy shock wave therapy on the erectile function of streptozotocin (STZ)-induced diabetic rats. Int J Mol Sci. 2013;14:10661-10673. DOI: https://doi.org/10.3390/ijms140510661
18. Assaly-Kaddoum R, Giuliano F, et al. Low-intensity extracorporeal shock wave therapy improves erectile function in a model of type II diabetes independently of NO/cGMP pathway. J Urol. 2016;196:950-956. DOI: https://doi.org/10.1016/j.juro.2016.03.147
19. Mense S, Hoheisel U. Shock wave treatment improves nerve regeneration in the rat. Muscle Nerve. 2013; 47:702-710. DOI: https://doi.org/10.1002/mus.23631
20. Drury R, Natale C, Hellstrom WJG. Reviewing the evidence for shockwave- and cell-based regenerative therapies in the treatment of erectile dysfunction. Ther Adv Urol. 2021; 13. DOI: https://doi.org/10.1177/17562872211002059
21. Scroppo FI, Pezzoni F, Gaeta F, et al. Li-ESWT improves hemodynamic parameters thus suggesting neoangiogenesis in patients with vascular erectile dysfunction. Int J Impot Res. 2022; 34:237-242. DOI: https://doi.org/10.1038/s41443-021-00411-0
22. Ciampa AR, de Prati AC, Amelio E, et al. Nitric oxide mediates anti-inflammatory action of extracorporeal shock waves. FEBS Lett. 2005;579:6839-6845. DOI: https://doi.org/10.1016/j.febslet.2005.11.023
23. Sokolakis I, Dimitriadis F, Psalla D, et al. Effects of low-intensity shock wave therapy (LiST) on the erectile tissue of naturally aged rats. Int J Impot Res. 2019; 31:162-169. DOI: https://doi.org/10.1038/s41443-018-0064-0
24. Musa ZS, El Assmy A, Shokry AM, et al. Long-term effectiveness and predictors of success of low-intensity shockwave therapy in phosphodiesterase type 5 inhibitor non-responders. Arab J Urol. 2020;18:54-58. DOI: https://doi.org/10.1080/2090598X.2019.1688072
25. Yao RJ, Wang MY, Chen Q, et al. Retrospective analysis of the efficacy of low-intensity extracorporeal shock wave therapy on young and middle-aged patients with erectile dysfunction responsive to PDE5Is. Sex Med. 2024; 12:qfae052. DOI: https://doi.org/10.1093/sexmed/qfae065
26. Mo DS, et al. Efficacy and safety of low-intensity extracorporeal shock wave therapy in the treatment of ED: a meta-analysis of randomized controlled trials. Andrologia. 2019; 61:e13289.
27. Zou ZJ, Tang LY, Liu ZH, et al. Short-term efficacy and safety of low-intensity extracorporeal shock wave therapy in erectile dysfunction: a systematic review and meta-analysis. Int Braz J Urol. 2017;43:805-821. DOI: https://doi.org/10.1590/s1677-5538.ibju.2016.0245
28. Kim KS, Jeong HC, Choi SW, et al. Electromagnetic low-intensity extracorporeal shock wave therapy in patients with erectile dysfunction: a sham-controlled, double-blind, randomized prospective study. World J Mens Health. 2020; 38:236-242. DOI: https://doi.org/10.5534/wjmh.190130
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