Is Low-Intensity Shockwave Therapy, GAINSwave, Effective for Treatment of Erectile Dysfunction?

What is erectile dysfunction (ED)?

Erectile dysfunction (ED) is a pathologic condition when a man cannot attain or maintain a penile erection sufficiently firm enough to have sexual intercourse. It is a common concern among men and affects about 50% of men aged 50 and above.¹ Not only does ED affect our quality of life, it is also associated with an increased risk of cardiovascular disease, stroke, hypertension and diabetes.^2,3 Hence, appropriate treatment of ED offers an opportunity to improve a man’s health in multiple ways.

What is low-intensity shockwave therapy and how is it used for ED?

Low-intensity extracorporeal shockwave therapy is an emerging treatment for ED. ESWT is believed to treat ED via two different mechanisms. Firstly, there is mechanical stress to tissues from exposure to the high-pressure shockwaves. Secondly, shockwaves can form cavitation bubbles, which when collapses, results in local micro trauma and neovascularization [formation of new blood vessels]. Neovascularization is one of the main hypothesis by which ESWT exerts its therapeutic effects on ED, as it promotes healing and tissue remodeling.⁴ Typically, the ESWT device is applied directly on multiple sites along the penile shaft and the penile glans. While there are no standardized protocols for the frequency of treatment, studies have reported twice per week sessions for 3 weeks, followed by a second cycle after another 3 weeks.⁵

What studies exist supporting the use of PRP for ED?

To date, the most recent study summarizing current clinical trials on ESWT as a treatment for ED was published by Campbell et al. in 2019.⁶ Overall, the studies concluded that patients with mild to moderate ED treated with ESWT after 1 month had improvements in both their International Index of Erectile Function (IIEF) scores and erectile hardness score (EHS). Moreover, there were minimal adverse effects related to this treatment modality. These results suggest the potential efficacy and safety of ESWT as a treatment for ED. Unfortunately, these studies are not without limitations. Firstly, long-term results are limited for these studies, with the longest outcome being reported at only one year of follow-up. Also, many of these trials comprised of patients who may not have completed the trial and therefore results may not represent comprehensive data.^7,8

What are the recommendations from the American Urological Association and Sexual Medicine Society of North America?

Due to inconsistencies in several study findings and small sample sizes, ESWT is still considered an investigational therapy per the current American Urological Association (AUA) and Sexual Medicine Society of North America (SMSNA) guidelines for ED.⁹ While studies have suggested the safety and efficacy of ESWT as a potential treatment modality for ED, larger, standardized clinical trials are necessary to confirm the effectiveness of ESWT prior to it being recommended widely to patients. Unfortunately, this therapy is still directly advertised to consumers and is readily available for purchase outside of the setting of a clinical study. 

Are there proven methods to effectively to treat ED?

Several effective and proven treatment options exist to treat ED. These treatments include oral medications, penile injections, vaccuum erection devices, and penile implants. Schedule an appointment with Dr. Chung to receive an in-depth evaluation of your history and symptoms to find the best treatment option for you.

References

1. Johannes CB, Araujo AB, Feldman HA, Derby CA, Kleinman KP, McKinlay JB. Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts male aging study. J. Urol. 2000;163(2):460-463.
2. Dong J-Y, Zhang Y-H, Qin L-Q. Erectile dysfunction and risk of cardiovascular disease: meta-analysis of prospective cohort studies. J. Am. Coll. Cardiol. 2011;58(13):1378-1385. doi:10.1016/j.jacc.2011.06.024.
3. Böhm M, Baumhäkel M, Teo K, et al. Erectile dysfunction predicts cardiovascular events in high-risk patients receiving telmisartan, ramipril, or both: The ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (ONTARGET/TRANSCEND) Trials. Circulation 2010;121(12):1439-1446. doi:10.1161/CIRCULATIONAHA.109.864199.
4. Bongrazio M, Da Silva-Azevedo L, Bergmann EC, et al. Shear stress modulates the expression of thrombospondin-1 and CD36 in endothelial cells in vitro and during shear stress-induced angiogenesis in vivo. Int J Immunopathol Pharmacol 2006;19(1):35-48.
5. 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(2):243-248. doi:10.1016/j.eururo.2010.04.004.
6. Campbell JD, Trock BJ, Oppenheim AR, Anusionwu I, Gor RA, Burnett AL. Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile dysfunction. Ther Adv Urol 2019;11:1756287219838364. doi:10.1177/1756287219838364.
7. Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee Y-C, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur. Urol. 2017;71(2):223-233. doi:10.1016/j.eururo.2016.05.050.
8. 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(1):27-35. doi:10.1016/j.jsxm.2016.11.001.
9. Burnett AL, Nehra A, Breau RH, et al. Erectile dysfunction: AUA guideline. J. Urol. 2018;200(3):633-641. doi:10.1016/j.juro.2018.05.004.

Author

Paul H. Chung, MD Paul H. Chung, MD is Assistant Professor of Urology and Director of Reconstructive Urology at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA