Illustration by Diego Sabogal
Some heavy-hitter urologists are testing a promising novel procedure known as shockwave therapy that could become a noninvasive, pill-free, game-changing fix in the treatment of erectile dysfunction (ED).
ED is a frustrating condition that experts say affects some 50 percent of men between the ages of 40 and 70.
Officially called low-intensity extracorporeal shockwave therapy (Li-ESWT), the procedure is more commonly known as shockwave therapy.
Treatment consists of noninvasive low-intensity sound waves that pass through erectile tissue, restoring natural erectile function by clearing plaque out of blood vessels and encouraging the growth of new blood vessels. The shockwave treatment offers a cure in that it reverses the problems that cause the dysfunction in the first place — the most desired win-win outcome coveted by men with ED.
But board-certified urologists are urging men seeking help for ED to do their homework before jumping into novel treatments that aren’t yet FDA approved.
Society warns men shockwave treatment isn’t FDA approved
On March 22, the Sexual Medicine Society of North America, Inc. (SMSNA) released a position statement warning men seeking ED treatment that new treatments being offered around the country aren’t FDA approved. “The Society recognizes the need for adequately powered, multicenter, randomized, sham/placebo-controlled trials in well-characterized patient populations to ensure that efficacy and safety are demonstrated for any novel ED therapy.”
They went on to list some of the unproven treatments, besides shockwave therapy, that are being offered: stem cell therapy; platelet-rich plasma (PRP), also known as the P-shot or the Priapus shot; and other agents, such as amniotic fluid.
The SMSNA believes that these therapies could potentially restore natural function and “regenerate erectile tissues.”
“There exists robust basic science evidence… supporting the ability of shockwave therapy and stem cell therapy to improve erectile function; however, to date, there is an absence of clinical trial data supporting their efficacy and long-term safety in humans.”
Any therapy available to help men with ED issues would have an undeniable quick-fix kind of appeal, but experts warn that the technology is in its infancy stages of research in the United States and isn’t ready for prime time until numerous clinical trials are wrapped up.
Given the current lack of regulatory agency approval for any restorative therapies for the treatment of ED and until such time as approval is granted, SMSNA believes the use of shock waves, stem cells, and platelet-rich plasma is experimental and should be conducted under research protocols in compliance with Institutional Review Board approval.
Bob Dole breakthrough
Let’s back up. It was former U.S. Senator and 1996 presidential candidate Bob Dole who came into our living rooms 20 years ago as the first Viagra pitchman for Pfizer.
Already known for his daunting rehabilitation from wounds he received in World War II, Dole had undergone a prostatectomy in 1991 while serving as a senator from the state of Kansas. The personal ED issues he discussed — to the chagrin of those watching television with their parents or grandparents — was a result of the surgery.
“You know, it’s a little embarrassing to talk about ED, but it’s important to millions of men and their partners,” he said in describing why he was speaking publicly about the condition.
How far have we come in the past two decades?
Blue pills aren’t a panacea
Irwin Goldstein, MD, board-certified urologist, director of sexual medicine at Alvarado Hospital in San Diego and the director of San Diego Sexual Medicine, is a trailblazer in the field of men’s sexuality. He explained that Viagra, the ubiquitous blue pills that serve as the current treatment for ED, aren’t a panacea.
“Pills do not work for everyone, and they’re incredibly expensive,” said Dr. Goldstein. “They [interfere] with certain health conditions, and many men discontinue their use for different reasons. But most importantly, they’re temporary, and they do not change the underlying pathophysiology of the condition.”
Dr. Goldstein explained the motivation for researchers to find a safe and appropriate alternative to pill therapy. “Through shockwave therapy, we are introducing a new paradigm of ED treatment that appears effective in changing the health of the penile tissue.”
He drove home the point that shockwave therapy for treating ED hasn’t received approval from the U.S. Food and Drug Administration (FDA), but he is working toward conducting a clinical trial later this year.
His center has nine trials ongoing in various areas of sexuality, and it has already completed a pilot study on men with ED in open-label context with the shockwave device, the Dornier Aries, made by Dornier MedTech Systems out of Germany. It’s still not approved for use in the United states outside of clinical trial use.
For the next step, Dr. Goldstein said, the FDA would require a multi-institutional sham-control trial with numerous institutions participating.
Like all of the board-certified urologists Healthline spoke to for this article, Dr. Goldstein urged readers to be wary of rogue operators who claim to be using FDA-approved shockwave therapy.
“There are healthcare providers offering treatments similar to shockwave, but there is no safety and efficacy data available and there’s absolutely no oversight as to the energy level provided to patients; theoretically, there could be harm with different energy levels,” said Dr. Goldstein. “It’s out of control and very sad, and desperate patients are caught in the middle. We take an oath to do no harm. So how would you know you are not causing harm until you’ve done the studies?”
FDA says shockwave tech for ED not approved
Stephanie Caccomo, a spokesperson from the FDA, confirmed that at this time, the only shockwave technology approved by the Center for Devices and Radiological Health (CDRH) of the FDA was the Sanuwave dermaPACE System, a Class II device, for use on conditions such as diabetic foot ulcers.
It delivers acoustic shock waves into the wound tissue to stimulate healing. Any device must be specifically approved for the condition being treated. Otherwise, it’s being used off-label, they said.
“If the public has concerns about unapproved products being marketed in inappropriate ways, we encourage consumers to file reports on our webpage for allegations of regulatory misconduct,” said Caccomo.
The sole clinical trial using shockwave therapy in the United States
The Renova-ED, manufactured by Direx Medical Systems Ltd., is in use by Dr. Ranjith Ramasamy at the University of Miami as part of the only current clinical trial to study shockwave therapy for erectile dysfunction. Image by Direx Medical Systems Ltd.
Ranjith Ramasamy, MD, assistant professor and director of reproductive urology at the University of Miami, is the principle investigator on the only ongoing clinical trial in the United States.
The study is titled “Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction.”
“Current nonsurgical ED treatment options include PDE-5 inhibitors (PDE5-i), such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra); vacuum erection devices; intracevernosal injections (P-shots); intraurethral suppositories; and penile implants,” said Dr. Ramasamy.
“All of these various treatments attempt to improve erectile function without really treating the underlying pathophysiology of ED, which leaves the question pending as to whether we can actually heal the dysfunctional penis.”
“The protocol schedule that we are using now is 10 minutes a day for either five days in a row — Monday, Tuesday, Wednesday, Thursday, Friday — with a follow-up at one month, three months, and then again at six months. Or we use Monday, Wednesday, Friday for two weeks,” Ramasamy said.
In that quest to learn if this treatment will be viable in the long run, Dr. Ramasamy said that his clinical trial was designed for 80 men and that he currently has 66 patients enrolled at their University of Miami site.
“Patients are paying $3,000 for non-FDA-approved treatments, and if they qualify for our trial, it’s free of charge,” he said, although the trial isn’t industry-funded. Dr. Ramasamy said that this current trial is being supported by private donors and philanthropic support, although two devices were given to him by the manufacturer, Direx Medical Systems Ltd., out of Israel.
To qualify for the trial, potential participants must meet the following criteria:
- be a male between 30 and 80 years of age
- have ED lasting for over six months but not more than five years
- have had a stable sexual relationship for over three months prior to enrollment
When asked if the 80-year-old mark for qualification was a bit on the high side, and also about “Mrs. Eighty,” Dr. Ramasamy was quick to respond: “That’s not true; we live in Miami, where sex is of paramount importance to all men regardless of their age. We have had irate patients who are 84 and 85 years of age call us asking why the cutoff is 80, and I feel bad for them, but that’s in our clinical trial criteria. Maybe in the next trial, we could design it to go to 90.”
Dr. Ramasamy said that his next trial will be a placebo trial where the participant will hear a sound, but the actual shock waves won’t get delivered. “We wanted to do this trial first to make sure it works — and it does,” he said.
Differences in wave energy
Shockwave therapy for treating ED, he noted, is quite different from extracorporeal shockwave lithotripsy (ESWL) used to treat kidney stones, a procedure that people have either had done in the last three decades or have at least heard about.
“ESWL has a smaller focal volume and the energy is concentrated to one spot, as opposed to ED where the shock waves are radial, the area is larger, and the energy is spread over that greater area,” Dr. Ramasamy explained. “In fact, the energy is about 10 percent of what we use for ESWL for kidney stones.”
Dr. Ramasamy was asked if it was possible that the machine could titrate the dosage up on its own or whether it had a built-in governor that would keep the energy at a certain level, the 10 percent of what is used for kidney stones. “We keep all maintenance records in an FDA-required format,” he said. “The device has a shut-off point. You can keep turning the dial as much as you want and there will be no higher intensity. The machine will cut off — like a hot water heater in your house.”
At the end of the numerous clinical trials that will be conducted by urological centers in the United Stated, Dr. Ramasamy said that an ideal regimen will be known, but only after a lot of documented study on a lot of subjects.
“Meanwhile, men seeking ED treatment should be very wary of non-doctors and chiropractors treating patients with what they say is shockwave therapy but is actually an acoustic vibrator,” he said. “Men are vulnerable and will do anything to have sex; men are willing to do anything to achieve an erection. It’s important for doctors and the medical community to keep an eye on what is correct.”
Shockwave therapy is the only current treatment on the horizon for ED that might offer a cure, which is the most desired outcome for men with ED. Shockwave therapy has also been suggested to improve the effect of pill therapy in nonresponders, reducing the need for more invasive treatments. Several single-arm trials have shown the benefit of shockwave therapy on patient-reported erectile function scores. Data from randomized trials appear to be conflicting, however, so questions remain to be answered before this therapy can routinely be offered to people.