The Next Frontier: Device-Based Erectile Rejuvenation

Low-intensity cutaneous shockwave treatment represents a novel option for the treatment of vasculogenic ED.

With David J. Goldberg, MD, JD
 

More than half of all men will experience some form of erectile dysfunction (ED) during the course of their lifetime. ED may be a harbinger of diabetes, cardiovascular disease, dyslipidemia, hypertension, and more, yet it goes unreported 80 percent of the time, because doctors and patients are reluctant to discuss their sexual health.

Nonsurgical vaginal rejuvenation has been getting attention due to an advent of devices that aim to help restore this area, as well as recent FDA scrutiny about potentially misleading claims made by some of these device companies (See call-out). Much less attention has been paid to improving male intimate wellness via energy-based devices—there is extremely low awareness about a highly effective option for ED known as low-intensity cutaneous shockwave treatment with the Zimmer ZWave. With this therapy, the acoustic waves trigger neovascularization to improve blood flow to the penis.

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This treatment targets vasculogenic ED, which makes up about 80 percent of cases. As such, most men respond to PDE5 inhibitors, but would prefer to reduce dependence on these drugs. And, there are some men who do not respond to oral agents but respond to this treatment. Candidates for device-based treatment have not undergone surgical treatments of the penis and do not have major anatomical issues.

How Well Does it Work?

A review1 of seven studies comprising 602 men with vasculogenic ED compared the efficacy of low-intensity cutaneous shockwave treatment versus placebo. Participants received two treatments per week for three weeks, then three weeks without treatment followed by three weeks of two treatments per week. There was a statistically significant improvement in Evaluation of International Index of Erectile Dysfunction Scores after the second series of treatments, and this improvement lasted for at least one year with no significant adverse events.

Preliminary results from a Phase 2 trial2 provide further evidence that this therapy is safe and effective for ED, with two treatments per week producing the most robust effect.

Education and awareness are key. I founded a new CME program focused on sexual health and wellness for men and women to help increase awareness about these issues, their treatment and the dermatologist’s role in providing care. Workshops are available: x-medica.com/intimatewellness.

1. Clavijo RI, et al. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. (2017). J Sex Med. Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001.

2. Katz JE, et al. A Phase 2 Randomized Trial To Evaluate Different Dose Regimens of Low-intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction: Clinical Trial Update. (2018). Eur Urol Focus. 2018 Apr;4(3):336-337.

This article is based on a presentation given at Cosmetic Surgery Forum (CSF) 2018. CSF moves to Nashville December 4-7, 2019: cosmeticsurgeryforum.com.

David J. Goldberg, MD, JD, is Director of Skin Laser & Surgery Specialists of New York and New Jersey, former Director of Mohs Surgery and Laser Research at the Icahn School of Medicine at Mt. Sinai, and an Adjunct Professor of Law, Fordham Law School.

 

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About Practical Dermatology

Practical Dermatology is the monthly publication that provides coverage of medical care, cosmetic advancements, and practice management for clinicians in the field. With straight-forward, how-to advice from experts in various fields, we strive to enhance quality of care and improve the daily operation of dermatology practices.