It is unethical in my opinion, based on the existing medical and scientific evidence, to charge patients with sexual function concerns for shock wave therapy (SWT), apart from the specific cohort of men with erectile dysfunction of vascular etiology. I make this statement based on (1) existing medical society guidelines, (2) peer-reviewed scientific publications, (3) my understanding of the putative mechanism of action of SWT, (4) the physiology of erection and sexual dysfunctions, and (5) my extensive personal experience. Importantly, I fully support and champion the need for novel therapies and for the development of new restorative technologies for men with sexual dysfunction.

Ethics, as defined by the Oxford English Dictionary,¹ is a set moral principles that govern a person’s behavior or the conducting of an activity. “Ethics examines the rational justification for our moral judgments; it studies what is morally right or wrong, just or unjust.”²

Medical ethics represents that set of core beliefs that we, as health care providers, aspire to uphold in our daily practice of medicine, and is often described as being composed of 4 foundational pillars, adapted below:³

1. Beneficence (doing good)
2. Non-maleficence (to do no harm)
3. Autonomy (giving the patient the freedom to choose freely, where they are able)
4. Justice (ensuring fairness)

With this understanding as a foundation of our discussion on the question of whether SWT for sexual dysfunctions is ethical, and an acknowledgment that as evidence is produced and techniques and equipment evolve my stance may change, I would put to the reader that as of today, it is unethical to charge for this therapy for all sexual dysfunctions. The 1 exception would be in patients with mild to moderate arteriogenic-induced erectile dysfunction, in which the patient understands that whatever positive effect they may experience from this treatment, it will likely be short-lived.

A wide range of sexual dysfunctions are advertised as suitable for SWT among U.S.- and Canadian-based treatment centers, including Peyronie’s disease, pelvic pain, prostatitis, post-prostatectomy erectile dysfunction, and premature and delayed ejaculation.

In my view, 3 simple questions need to be asked to determine if a treatment is truly “ethical:”

1. Is it safe (short-term and long-term)?
2. Is it likely to be effective for the individual in front of you (or at least can you provide a reasonable estimate of efficacy and durability)?
3. Can informed consent be provided for the treatment in question, based on how it compares to the peer-reviewed evidence and knowledge of alternative treatments?

The existing world peer-reviewed literature on SWT demonstrates clear safety and evidence of modest efficacy in selected populations of men, best targeted at arteriogenic erectile dysfunction. Many studies and meta-analyses have demonstrated improvement in erectile function based on questionnaires; however, no single energy source, energy density, treatment protocol, or means to identify responders has yet been defined. It appears that even among responders, loss of effectiveness is experienced over a defined period (23% response rate at 2-year follow-up among “severe” erectile dysfunction cases).⁴

In contrast, near unanimity has been achieved among medical societies, scholarly reviewers, and associations (AUA, European Association of Urology, International Society for Sexual Medicine, Canadian Urological Association, and Cochrane Reviews) in their guideline recommendations for other sexual concerns including Peyronie’s disease, pelvic pain, and prostatitis.^5–8 Based on a comprehensive review of prospective clinical trials, subsequent single-center reports and recent integrated meta-analyses for Peyronie’s disease demonstrate that the utility of SWT remains unproven and it is not yet ready for widespread clinical application outside of a clinical trial.⁹ Improvement in pain in men with Peyronie’s disease has led to many guidelines suggesting that SWT “may be offered,” but no evidence of improved function, curvature reduction, or enhanced penile length is reported.

Additionally, thoughtful consensus has been achieved across a wide range of publications providing similar clinical guidance that, based on the currently available published literature, SWT is not yet ready for routine clinical use.^10,11 The evident deficiencies of this therapy remain the lack of data supporting a best protocol, an ideal density of energy, optimal frequency of treatment, identification of the ideal candidate or targeted pathology, the lack of long-term outcome data, and absence of true prognostic information for an individual patient.

Returning to the 3 critical questions that, in my mind, define whether a treatment is ethical, SWT for a broad range of sexual dysfunctions (1) is safe, but (2) has unpredictable efficacy for an individual based on poorly defined treatment parameters, and (3) given the uncertainties related to treatment dose, effect, and durability, a positioning of SWT in context of alternatives is not possible.

In summary, while SWT has been proven safe, its utility remains to be more fully defined, and as such, I would find it unethical to charge patients at the present time for this treatment. There is no doubt in my view that there exists a genuine need for restorative approaches that target Peyronie’s disease, ejaculatory dysfunction, neural and vasculogenic erectile dysfunction, as well as many other sexual dysfunctions. SWT is just not that therapy, yet.

The companion article to “Shock Wave Therapy: Is It Ethical to Offer and Charge for Erectile and Other Sexual Dysfunctions?” will be published in the March 2023 issue of AUANews (volume 28, issue 3).