Off-label use of low-intensity extracorporeal shockwave therapy for treating erectile dysfunction (ED) is growing in popularity in the United States in part because of extensive advertising. Similar to what is used for treating kidney stones and gallstones, this approach may help men who cannot take an oral phosphodiesterase type 5 (PDE5) inhibitor or who do not respond to it. There is a growing concern, however, that many men are paying thousands of dollars for something that may offer them little or no benefit.
So far, it appears that it could be somewhat effective and probably safe in the short-term treating select men with ED. The authors of a review article in The Medical Letter on Drugs and Therapeutics, however, noted that longer-term effects might include irreversible scarring, reduced blood flow, penile curvature, and urethral stricture formation. The authors wrote that that long-term data are lacking, and there is no standardization in terms of the optimal treatment regimen.1
A meta-analysis of 16 randomized controlled trials that included 1064 men with ED demonstrated that men who received low-intensity shockwave therapy in had significantly higher scores on the International Index of Erectile Function (IIEF-5) instrument compared with those who received a sham treatment, investigators reported in the American Journal of Men’s Health.2
In an open-label, single-arm trial that included 30 patients with ED in Australia, 18 patients (60%) reported a greater than 5-point improvement in their IIEF-5 score 6 weeks after shockwave therapy, and 15 patients (50%) achieved spontaneous erections capable of sexual penetration, according to study findings published in BJU International.3 Patients received the low-intensity shockwaves to the penis twice weekly for 6 weeks. Each treatment session lasted 15 minutes.
“I think the body of literature is growing in support of this therapy for the right patient,” said Katherine Rotker, MD, an assistant professor of urology at the Yale School of Medicine in New Haven, Connecticut. She said the treatment was initially thought to be somewhat fringe, and the majority of practitioners offering this service were non-urologists. “I think this has been changing recently,” said Dr Rotker, who noted that a significant number of academic urologists who specialize in ED are now offering this therapy at their institutions.
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How the Treatment Works
“The theory is that this [treatment] can stimulate the expression of angiogenesis-related factors, such as vascular endothelial growth factor so as to promote vascular regeneration,” Dr Rotker explained. “There also are posited mechanisms related to recruitment of progenitor cells and nerve regeneration, possible Schwann cell proliferation.”
Shockwave therapy was introduced in the field of orthopedics decades ago. It became an established treatment for some musculoskeletal disorders and tendinopathies. “We recently started offering this therapy for ED just about a month ago,” Dr Rotker said. “We have only treated approximately 10 patients. It is completely pain-free. Although the efficacy may be debated, no real debate on safety. None of the studies that have been published to date have shown any adverse events.”
No Protocol Consensus
Dr Rotker pointed out that there is a difference between focused shockwaves (from a class 2 device) and radial waves (from a class 1 device; no efficacy data available). In addition, there is no consensus as to a treatment protocol (such as number of shocks per treatment, number of treatments, length of therapy). Men who had mild to moderate ED not related to diabetes appear to have the most benefit based on current literature, Dr Rotker said.
The treatment only takes about 15 minutes and is usually given once or twice weekly, and continued for a minimum of 6 sessions. Shockwaves are administered with a probe placed directly on the penis.
Urologic surgeon Douglas Dahl, MD, chief of urologic oncology at Massachusetts General Hospital in Boston, said he strongly agrees with the AUA guidelines recommending that this treatment should be carefully evaluated in a clinical trial setting.4 “I am concerned that it is costing patients a lot of their own money and they will have a strong desire to see success. The IIEF score may not be the optimal measure of success,” Dr Dahl said.
Efficacy Not Established
“In its current state, the efficacy of low-intensity shock wave treatment has not been established,” said Jean-Francois Eid, MD, an ED specialist with Advanced Urological Care in New York, New York. “It is still experimental and as such patients should not be responsible for the cost.”
Regarding the Australia study, Dr Eid pointed out that the procedure was performed with a Class 2 FDA regulated machine that in the United States cannot be used outside of a clinical trial. Class 1 shockwave machines are currently the only ones available in the US for clinical use and are totally unregulated.
He added, “Many desperate patients are being taken advantage of. The only good thing about it is that, since it doesn’t do anything, it’s also harmless. Ironically, the fact that it is harmless incentivizes or perpetuates the scam.”
For now, Dr Eid said, the only patients who would benefit from the shockwave treatment are men who suffer from psychogenic ED, who could possibly respond to a placebo effect.
John P. Smith, DO, of the University of Utah Health in Salt Lake City, who has used low-intensity shockwave therapy to treat hundreds of ED cases, said men with mild ED experience some improvement, and men with moderate to severe ED are less likely to see improvement. “Low-intensity shockwave therapy has caught on in the sense that many people have heard the advertisements that have been blasted across the radio and television. Most people are very skeptical,” said Dr Smith, who is board certified in family medicine and has completed a fellowship in genitourinary medicine.
Dr Smith noted that the treatment is cost prohibitive for many patients. As the treatment is low intensity, it is not painful. The ideal patients for shockwave therapy are those with a very mild ED who have done well on low-dose PDE5 inhibitors.
References
1. No authors listed. Shockwave therapy for erectile dysfunction. Med Lett Drugs Ther. 2023;65(1690):190-191. doi:10.58347/tml.2023.1690d
2. Yao H, Wang X, Liu H, et al. Systematic review and meta-analysis of 16 randomized controlled trials of clinical outcomes of low-intensity extracorporeal shock wave therapy in treating erectile dysfunction. Am J Mens Health. 2022;16(2):15579883221087532. doi:10.1177/15579883221087532
3. 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 Suppl 5:46. doi:10.1111/bju.13035
4. Burnett AL, Nehra A, Breau RH, et al. Erectile dysfunction: AUA guideline. J Urol. 2018;200:633-641. doi:10.1016/j.juro.2018.05.004
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