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Shockwave or ‘P-Shot’ for Erectile Dysfunction? Don’t Risk It

January 13, 2023

Connect with a men’s health expert for help with sexual function

If you were among the 50 percent of adult males between the ages of 40 and 70 with erectile dysfunction, would you pay thousands of dollars for a treatment not yet approved by the Food and Drug Administration amid uncertainties about its long-term effectiveness and safety?

Especially if that treatment, shockwave therapy, delivers sound waves through your erectile tissue?

Not only are some men seeking this treatment, but they’re also choosing penile injections of either platelet-rich plasma or their own stem cells — neither approved by the FDA.

Resist the temptation, and high prices, of quick-fix treatments lacking federal regulatory agency approval, says Dr. Jared Bieniek, medical director of Hartford HealthCare Tallwood Men’s Health.

“Sexual medicine physicians should use up-to-date research and guidelines in treating each man,” he says.

Here’s a quick look at the three experimental treatments that, despite showing promise, are still not considered safe.

> Concerned about sexual function? Connect with a men’s health specialist

Shockwave therapy

Shockwave has been a common treatment the past 30 years for kidney stones, using sound waves strong enough to break up a stone. Some doctors have adapted a milder form of the technology — it’s known formally as low-intensity extracorporeal shockwave therapy — for patients with erectile dysfunction. The therapy increases blood flow to the penis (during a normal erection, blood fills the penis) and promotes new blood-vessel growth.

In March, the Sexual Medicine Society of North America acknowledged “robust basic science evidence” in multiple animal studies but warned that potential shockwave patients should be “fully informed and consented regarding the potential benefits and risks” because of a lack of clinical trials to determine its safety in humans.

For now, a clinical trial at the University of Miami is the only ongoing study of shockwave therapy for erectile dysfunction in the United States.

“European groups have shown benefit in humans,” says Dr. Bieniek, “although long-term results and side effects are not well-known.”

Platelet-rich plasma injections

A P-Shot, as it’s known, is an injection of platelet-rich plasma sourced from the patient’s own blood. The 30-minute procedure can encourage new blood-vessel growth in patients with poor circulation, diabetes or prostate cancer. Some men also seek this treatment because it can increase the length and girth of a penis. The results last about a year.

As with the other treatments, the Sexual Medicine Society of North America noted its “potentially restorative modalities based on the concept that they might regenerate erectile tissues” while recommending more high-quality research.

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Stem cell treatment

Researchers in Denmark, in limited testing on patients whose cancerous prostate glands had been removed, found that injecting stem cells restored the penis’ function — and even made it slightly bigger. “These treatments are purely experimental with little data,” says Dr. Bieniek.

FDA approved treatments

These treatments have been tested and proven safe for the treatment of erectile dysfunction:

  • Oral medications: PDE inhibitors, such as Viagra, Cialis, Levitra and Stendra, that inhibit the enzyme that controls blood flow to the penis’ soft tissue.
  • Vacuum erection device: An external pump with a band that allows a man to get and maintain an erection.
  • Intraurethral suppository (MUSE): Promotes blood flow to the penis.
  • Penile injections: An injected medication, such as Alprostadil, that increases blood flow to the penis.
  • Penile prosthetics: Malleable or inflatable implants.

“These approved treatments are used on an as-needed basis for satisfactory erections but don’t treat the underlying cause of ED,” says Dr. Bieniek.

Tips when seeking ED treatment

Here’s how to avoid treatment that is not FDA approved and ED treatment scams:

  • Do your homework. Your personal family physician and a urologist are best versed to review your concerns, overall health and determine appropriate treatment.
  • When seeing a new doctor for erectile dysfunction, ask about his or her training background. Any physician other than your family physician should have specific training in ED (this includes all urologists). Urologists with additional experience or training in sexual medicine are also available for complex cases.
  • Ask what technology or machine your doctor will be using. In some cases, shockwave therapy providers use glorified acoustic vibrators incapable of providing the proper energy level instead of true shockwave machines.
  • Know all costs before you agree to treatment. Insurance covers most doctor’s visit costs. Question any high-cost treatments. You don’t want to be surprised with a bill later.

> Connect with a men’s health expert for help with sexual function