Clinical studies on low intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic review and meta-analysis of randomised controlled trials

Abstract

The efficacy of low intensity extracorporeal shock wave therapy (LI-ESWT) for erectile dysfunction (ED) has received hard criticism and recently published meta-analyses were not able to provide further insights, nor specific recommendations. The aim of this systematic review and meta-analysis is to evaluate the efficacy of LI-ESWT for ED, identify the ideal treatment population and treatment protocol, and provide recommendations for future research in the field. A systematic research for relevant clinical studies published from January 2010 to September 2018 was performed, using the following databases: Medline, Embase, The Cochrane Library, Scopus, and Web of Science. Only clinical studies that investigated the efficacy of LI-ESWT for ED only, and reported primary outcomes using IIEF-EF scores/questionnaires were included. Both, randomised controlled trials (RCTs) and cohort studies were included, but the meta-analysis was performed only for sham-controlled RCTs. Ten RCTs including 873 patients were selected for the meta-analysis. Pooling data of these studies showed that LI-ESWT could significantly improve erectile function in men with ED regarding both patient-subjective outcomes (IIEF-EF: +3.97; 95% CI [2.09–5.84]; p < 0.0001, EHS ≥ 3: OR: 4.35; 95% CI [1.82–10.37]; p = 0.0009) and patient-objective outcomes (peak systolic velocity: +4.12; 95% CI [2.30–5.94]; p < 0.00001). In conclusion, the present meta-analysis provided results showing that LI-ESWT significantly improves erectile function in patients with vasculogenic ED.

Access options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5

References

  1. 1.

    Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010;58:243–8.

    Article  Google Scholar 

  2. 2.

    Fode M, Lowenstein L, Reisman Y. Low-intensity extracorporeal shockwave therapy in sexual medicine: a questionnaire-based assessment of knowledge, clinical practice patterns, and attitudes in sexual medicine practitioners. Sex Med. 2017;5:e94–8.

    Article  Google Scholar 

  3. 3.

    Fode M, Hatzichristodoulou G, Serefoglu EC, Verze P, Albersen M. Low-intensity shockwave therapy for erectile dysfunction: is the evidence strong enough? Nat Rev Urol. 2017;14:593.

    CAS  Article  Google Scholar 

  4. 4.

    Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151:264–9.

    Article  Google Scholar 

  5. 5.

    Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. http://handbook.cochrane.org.

  6. 6.

    Chitale S, Morsey M, Swift L, Sethia K. Limited shock wave therapy vs sham treatment in men with Peyronie’s disease: results of a prospective randomized controlled double‐blind trial. BJU Int. 2010;106:1352–6.

    Article  Google Scholar 

  7. 7.

    Hatzichristodoulou G, Meisner C, Gschwend JE, Stenzl A, Lahme S. Extracorporeal shock wave therapy in Peyronie’s disease: results of a placebo-controlled, prospective, randomized, single-blind study. J Sex Med. 2013;10:2815–21.

    Article  Google Scholar 

  8. 8.

    Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011;60:1010–6.

    Article  Google Scholar 

  9. 9.

    Souper R, Hartmann J, Alvarez M, Fuentes I, Astroza G, Marconi M. Correlation between peak systolic velocity and diameter of cavernosal arteries in flaccid versus dynamic state for the evaluation of erectile dysfunction. Int J Impot Res. 2017;29:132.

    CAS  Article  Google Scholar 

  10. 10.

    Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.

    Article  Google Scholar 

  11. 11.

    Gruenwald I, Appel B, Vardi Y. Low‐intensity extracorporeal shock wave therapy—A novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012;9:259–64.

    Article  Google Scholar 

  12. 12.

    Bechara A, Casabé A, De Bonis W, Nazar J. Effectiveness of low-intensity extracorporeal shock wave therapy on patients with erectile dysfunction (ED) who have failed to respond to PDE5i therapy. A pilot study. Arch Esp Urol. 2015;68:152–60.

    PubMed  Google Scholar 

  13. 13.

    Chung E, Cartmill R. Evaluation of clinical efficacy, safety and patient satisfaction rate after low‐intensity extracorporeal shockwave therapy for the treatment of male erectile dysfunction: an Australian first open‐label single‐arm prospective clinical trial. BJU Int. 2015;115:46–9.

    Article  Google Scholar 

  14. 14.

    Pelayo-Nieto M, Linden-Castro E, Alias-Melgar A, Grovas DE, Carreño-de la Rosa F, Bertrand-Noriega F, et al. Linear shock wave therapy in the treatment of erectile dysfunction. Actas Urol Esp. 2015;39:456–9.

    CAS  Article  Google Scholar 

  15. 15.

    Reisman Y, Hind A, Varaneckas A, Motil I. Initial experience with linear focused shockwave treatment for erectile dysfunction: a 6-month follow-up pilot study. Int J Impot Res. 2015;27:108.

    CAS  Article  Google Scholar 

  16. 16.

    Ruffo A, Capece M, Prezioso D, Romeo G, Illiano E, Romis L, et al. Safety and efficacy of low intensity shockwave (LISW) treatment in patients with erectile dysfunction. Int Braz J Urol. 2015;41:967–74.

    CAS  Article  Google Scholar 

  17. 17.

    Bechara A, Casabé A, De Bonis W, Ciciclia PG. Twelve-month efficacy and safety of low-intensity shockwave therapy for erectile dysfunction in patients who do not respond to phosphodiesterase type 5 inhibitors. Sex Med. 2016;4:e225–32.

    Article  Google Scholar 

  18. 18.

    Frey A, Sønksen J, Fode M. Low-intensity extracorporeal shockwave therapy in the treatment of postprostatectomy erectile dysfunction: a pilot study. Scand J Urol. 2016;50:123–7.

    Article  Google Scholar 

  19. 19.

    Hisasue SI, China T, Horiuchi A, Kimura M, Saito K, Isotani S, et al. Impact of aging and comorbidity on the efficacy of low‐intensity shock wave therapy for erectile dysfunction. Int J Urol. 2016;23:80–4.

    CAS  Article  Google Scholar 

  20. 20.

    Ayala HA, Cuartas JP, Cleves DC. Impact on the quality of erections after completing a low-intensity extracorporeal shock wave treatment cycle on a group of 710 patients. Adv Urol. 2017:1843687. https://doi.org/10.1155/2017/1843687.

    CAS  Article  Google Scholar 

  21. 21.

    Tsai CC, Wang CJ, Lee YC, Kuo YT, Lin HH, Li CC, et al. Low-intensity extracorporeal shockwave therapy can improve erectile function in patients who failed to respond to phosphodiesterase type 5 inhibitors. Am J Mens Health. 2017;11:1781–90.

    Article  Google Scholar 

  22. 22.

    Chen X, Huang HW, Zhu XB, Chen GX, Li PC, Song F, et al. Focused low-intensity extracorporeal shock wave therapy for erectile dysfunction: preliminary observation of 32 cases. Natl J Androl. 2018;24:529–32.

    Google Scholar 

  23. 23.

    Kitrey ND, Vardi Y, Appel B, Shechter A, Massarwi O, Abu-Ghanem Y, et al. Low intensity shock wave treatment for erectile dysfunction—how long does the effect last? J Urol. 2018;200:167–170.

    Article  Google Scholar 

  24. 24.

    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. J Urol. 2012;187:1769–75.

    Article  Google Scholar 

  25. 25.

    Yee CH, Chan ES, Hou SS, Ng CF. Extracorporeal shockwave therapy in the treatment of erectile dysfunction: a prospective, randomized, double‐blinded, placebo controlled study. Int J Urol. 2014;21:1041–5.

    Article  Google Scholar 

  26. 26.

    Olsen AB, Persiani M, Boie S, Hanna M, Lund L. Can low-intensity extracorporeal shockwave therapy improve erectile dysfunction? A prospective, randomized, double-blind, placebo-controlled study. Scand J Urol. 2015;49:329–33.

    Article  Google Scholar 

  27. 27.

    Srini VS, Reddy RK, Shultz T, Denes B. Low intensity extracorporeal shockwave therapy for erectile dysfunction: a study in an Indian population. Can J Urol. 2015;22:7614–22.

    Google Scholar 

  28. 28.

    Kitrey ND, Gruenwald I, Appel B, Shechter A, Massarwa O, Vardi Y. Penile low intensity shock wave treatment is able to shift PDE5i nonresponders to responders: a double-blind, sham controlled study. J Urol. 2016;195:1550–5.

    Article  Google Scholar 

  29. 29.

    Motil I, Kubis I, Sramkova T. Treatment of vasculogenic erectile dysfunction with Piezowave2 device. Application of low intensity shockwaves using novel linear shockwave tissue coverage (LSTC-ED®) technique. A prospective, multicentric, placebo-controlled study. Adv Sex Med. 2016;6:15.

    Article  Google Scholar 

  30. 30.

    Fojecki GL, Tiessen S, Osther PJ. Effect of low-energy linear shockwave therapy on erectile dysfunction—a double-blinded, sham-controlled, randomized clinical trial. J Sex Med. 2017;14:106–12.

    Article  Google Scholar 

  31. 31.

    Kalyvianakis D, Hatzichristou D. Low-intensity shockwave therapy improves hemodynamic parameters in patients with vasculogenic erectile dysfunction: a triplex ultrasonography-based sham-controlled trial. J Sex Med. 2017;14:891–7.

    Article  Google Scholar 

  32. 32.

    Yamaçake KG, Carneiro F, Cury J, Lourenço R, Françolin PC, Piovesan AC, et al. Low-intensity shockwave therapy for erectile dysfunction in kidney transplant recipients. A prospective, randomized, double blinded, sham-controlled study with evaluation by penile Doppler ultrasonography. Int J Impot Res. 2018;14:1.

  33. 33.

    Zewin TS, El-Assmy A, Harraz AM, Bazeed M, Shokeir AA, Sheir K, et al. Efficacy and safety of low-intensity shock wave therapy in penile rehabilitation post nerve-sparing radical cystoprostatectomy: a randomized controlled trial. Int Urol Nephrol. 2018;19:1–8.

  34. 34.

    Qi T, Ye L, Wang B, Zhang B, Chen J. Comparison of the effects of extracorporeal shock wave therapy and a vacuum erectile device on penile erectile dysfunction: a randomized clinical trial. Medicine. 2017;96:e8414.

    Article  Google Scholar 

  35. 35.

    Fojecki GL, Tiessen S, Osther PJ. Effect of linear low-intensity extracorporeal shockwave therapy for erectile dysfunction—12-Month follow-up of a randomized, double-blinded, sham-controlled study. Sex Med. 2018;6:1–7.

    Article  Google Scholar 

  36. 36.

    Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. Low-intensity shockwave therapy for erectile dysfunction: a randomized clinical trial comparing 2 treatment protocols and the impact of repeating treatment. J Sex Med. 2018;15:334–45.

    Article  Google Scholar 

  37. 37.

    Katz JE, Molina ML, Clavijo R, Prakash NS, Ramasamy R. A phase 2 randomized trial to evaluate different dose regimens of low-intensity extracorporeal shockwave therapy for erectile dysfunction: clinical trial update. Eur Urol Focus. 2018. https://doi.org/10.1016/j.euf.2018.07.011.

    Article  PubMed  Google Scholar 

  38. 38.

    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;71:223–33.

    Article  Google Scholar 

  39. 39.

    Angulo JC, Arance I, de Las Heras MM, Meilán E, Esquinas C, Andrés EM. Efficacy of low-intensity shock wave therapy for erectile dysfunction: a systematic review and meta-analysis. Actas Urol Esp. 2017;41:479–90.

    CAS  Article  Google Scholar 

  40. 40.

    Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of low-intensity extracorporeal shockwave therapy on erectile dysfunction: a systematic review and meta-analysis. J Sex Med. 2017;14:27–35.

    Article  Google Scholar 

  41. 41.

    Zou ZJ, Tang LY, Liu ZH, Liang JY, Zhang RC, Wang YJ, 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;43:805–21.

    Article  Google Scholar 

  42. 42.

    Man L, Li G. Low-intensity extracorporeal shock wave therapy for erectile dysfunction: a systematic review and meta-analysis. Urology. 2018;119:97–103.

    Article  Google Scholar 

  43. 43.

    Gao L, Qian S, Tang Z, Li J, Yuan J. A meta-analysis of extracorporeal shock wave therapy for Peyronie’s disease. Int J Impot Res. 2016;28:161.

    CAS  Article  Google Scholar 

  44. 44.

    Feldman R, Denes B, Appel B, et al. The safety and efficacy of Li-ESWT in 604 patients for erectile dysfunction: summary of current and evolving evidence. J Urol. 2015;193:e905–6.

    Google Scholar 

  45. 45.

    Hatzichristou D. Low-intensity extracorporeal shock waves therapy (LI-ESWT) for the treatment of erectile dysfunction: Where do we stand? Eur Urol. 2017;71:234–6.

    Article  Google Scholar 

  46. 46.

    Fode M, Albersen M, Østergren PB. Is low-intensity shockwave therapy for erectile dysfunction ready for clinical practice? Int J Impot Res. 2018. https://doi.org/10.1038/s41443-018-0081-z.

    Article  PubMed  Google Scholar 

  47. 47.

    Sokolakis I, Dimitriadis F, Psalla D, Karaliulakis G, Kalyvianakis D, Hatzichristou D. Effects of low-intensity shock wave therapy (LiST) on the erectile tissue of naturally aged rats. Int J Impot Res. 2018. https://doi.org/10.1038/s41443-018-0064-0.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Georgios Hatzichristodoulou.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Additional information

Publisher’s note: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Sokolakis, I., Hatzichristodoulou, G. 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 31, 177–194 (2019). https://doi.org/10.1038/s41443-019-0117-z

Download citation

Further reading