World J Mens Health.  2020 Apr;38(2):236-242. 10.5534/wjmh.190130.

Electromagnetic Low-Intensity Extracorporeal Shock Wave Therapy in Patients with Erectile Dysfunction: A Sham-Controlled, Double-Blind, Randomized Prospective Study

• Kim KS
• Jeong HC
• Choi SW
• Choi YS
• Cho HJ
• Ha US
• Hong SH
• Lee JY
• Lee SW
• Ahn ST
• Moon DG
• Bae WJ
• Kim SW

• KMID: 2471830
• DOI: http://doi.org/10.5534/wjmh.190130

Abstract

PURPOSE
The aim of the present study was to evaluate the efficacy and safety of the electromagnetic-type low-intensity extracorporeal shock wave therapy (Li-ESWT) in patients with erectile dysfunction (ED).
MATERIALS AND METHODS
The randomized, sham-controlled, double-blind prospective study was performed at two referral hospitals. Participants were randomized in a 1:1 ratio to receive sham or Li-ESWT for 6 weeks. ED was evaluated at screening and at 4 and 7 weeks after treatment. Participants were asked to complete the international index of erectile function-erectile function (IIEF-EF) domain questionnaire, erection hardness scale (EHS), and sexual encounter profile questionnaire (SEPQ 2 and 3). The development of complications was investigated.
RESULTS
Eighty-one of 96 patients completed the study. The median change in the IIEF-EF score in the Li-ESWT and sham groups was 5.1 and −2.2 (p<0.001), respectively, at the 7-week follow-up; 47.4% (18/38) patients had EHS <3, of which 77.8% (14/18) showed significant improvement in virtue of Li-ESWT treatment (p=0.001). A significant improvement was observed in the percentage of "Yes" responses to SEPQ 2 and 3 in the Li-ESWT group vs. sham group from baseline to 7-week follow-up (91.3% vs. 69.4%; p=0.008 and 50.0% vs. 14.3%; p=0.002, respectively). No patients reported pain or other adverse events during treatment or follow-up.
CONCLUSIONS
Thus, Li-ESWT could have a role in improving erectile function. Furthermore, it is safe. We believe that Li-ESWT is an attractive new treatment modality for patients with ED.

Keyword

Electromagnetic; Erectile dysfunction; Humans; Low-intensity extracorporeal shock wave therapy

MeSH Terms

Erectile Dysfunction*
Follow-Up Studies
Hardness
Humans
Magnets*
Male
Mass Screening
Prospective Studies*
Referral and Consultation
Shock*
Virtues

Figure

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  Fig. 1 Subject disposition. Li-ESWT: low-intensity extracorporeal shock wave therapy.

• 

  Fig. 2 (A) Mean international index of erectile function-erectile function (IIEF-EF) domain score for patients treated with low-intensity extracorporeal shock wave therapy (Li-ESWT) or sham treatment at baseline, week 4, and week 7. (B) Comparison of the mean IIEF-EF domain score changes from baseline. ap<0.001 compared with baseline. bp<0.001.

Reference

1. NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993; 270:83–90. PMID: 8510302.

2. Rajfer J, Aliotta PJ, Steidle CP, Fitch WP 3rd, Zhao Y, Yu A. Tadalafil dosed once a day in men with erectile dysfunction: a randomized, double-blind, placebo-controlled study in the US. Int J Impot Res. 2007; 19:95–103. PMID: 16871272.

3. Hatzimouratidis K, Amar E, Eardley I, Giuliano F, Hatzichristou D, Montorsi F, et al. European Association of Urology. Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Eur Urol. 2010; 57:804–814. PMID: 20189712.

4. Schuüller J, Chaussy C. [A new therapy for urinary calculi. Noninvasive kidney stone crushing]. Krankenpfl Soins Infirm. 1984; 77:30–31. German.

5. Al-Abbad H, Simon JV. The effectiveness of extracorporeal shock wave therapy on chronic achilles tendinopathy: a systematic review. Foot Ankle Int. 2013; 34:33–41. PMID: 23386759.

6. Ito K, Fukumoto Y, Shimokawa H. Extracorporeal shock wave therapy for ischemic cardiovascular disorders. Am J Cardiovasc Drugs. 2011; 11:295–302. PMID: 21846155.

7. 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; 71:223–233. PMID: 27321373.

8. Gruenwald I, Appel B, Kitrey ND, Vardi Y. Shockwave treatment of erectile dysfunction. Ther Adv Urol. 2013; 5:95–99. PMID: 23554844.

9. Lei H, Liu J, Li H, Wang L, Xu Y, Tian W, et al. Low-intensity shock wave therapy and its application to erectile dysfunction. World J Mens Health. 2013; 31:208–214. PMID: 24459653.

10. Li H, Matheu MP, Sun F, Wang L, Sanford MT, Ning H, et al. Low-energy shock wave therapy ameliorates erectile dysfunction in a pelvic neurovascular injuries rat model. J Sex Med. 2016; 13:22–32. PMID: 26755082.

11. Nishida T, Shimokawa H, Oi K, Tatewaki H, Uwatoku T, Abe K, et al. Extracorporeal cardiac shock wave therapy markedly ameliorates ischemia-induced myocardial dysfunction in pigs in vivo. Circulation. 2004; 110:3055–3061. PMID: 15520304.

12. Cappelleri JC, Rosen RC, Smith MD, Mishra A, Osterloh IH. Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Urology. 1999; 54:346–351. PMID: 10443736.

13. 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; 187:1769–1775. PMID: 22425129.

14. Aicher A, Heeschen C, Sasaki K, Urbich C, Zeiher AM, Dimmeler S. Low-energy shock wave for enhancing recruitment of endothelial progenitor cells: a new modality to increase efficacy of cell therapy in chronic hind limb ischemia. Circulation. 2006; 114:2823–2830. PMID: 17145991.

15. 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; 58:243–248. PMID: 20451317.

16. 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; 43:805–821. PMID: 28379665.

17. 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. 2019; 31:177–194. PMID: 30664671.

18. Ogden JA, Tóth-Kischkat A, Schultheiss R. Principles of shock wave therapy. Clin Orthop Relat Res. 2001; (387):8–17. PMID: 11400898.

19. Jeong HC, Jeon SH, Qun ZG, Kim KS, Choi SW, Bashraheel F, et al. Effects of next-generation low-energy extracorporeal shockwave therapy on erectile dysfunction in an animal model of diabetes. World J Mens Health. 2017; 35:186–195. PMID: 29164834.

20. Zhu GQ, Jeon SH, Bae WJ, Choi SW, Jeong HC, Kim KS, et al. Efficient promotion of autophagy and angiogenesis using mesenchymal stem cell therapy enhanced by the low-energy shock waves in the treatment of erectile dysfunction. Stem Cells Int. 2018; 2018:1302672. PMID: 30228820.

21. Jeong HC, Bae WJ, Zhu GQ, Jeon SH, Choi SW, Kim SJ, et al. Synergistic effects of extracorporeal shockwave therapy and modified Ojayeonjonghwan on erectile dysfunction in an animal model of diabetes. Investig Clin Urol. 2019; 60:285–294.

22. 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; 195:1550–1555. PMID: 26694904.

23. Burnett AL, Nehra A, Breau RH, Culkin DJ, Faraday MM, Hakim LS, et al. Erectile dysfunction: AUA Guideline. J Urol. 2018; 200:633–641. PMID: 29746858.