Why is ED therapy ‘Shockwave’ not ready for Prime Time ?

Why is ED therapy 'Shockwave' not ready for Prime Time

The research behind shockwave therapy is promising for erectile dysfunction. But some practitioners cash in on the hype with treatments that are not approved by the FDA.

In the treatment of erectile dysfunction (ED), some heavy-hitter urologists are testing a promising novel procedure known as shockwave therapy that could become a non-invasive, pill-free, game-changing fix.

ED is a debilitating disorder that experts say affects about 50 percent of people between 40 and 70 years of age.

Officially referred to as the low-intensity extracorporeal shockwave therapy (Li-ESWT), the technique is more commonly referred to as shockwave care.

Treatment consists of non-invasive low-intensity sound waves passing through erectile tissue, restoring natural erectile function by clearing plaque out of the blood vessels and encouraging new blood vessel growth. The shockwave treatment provides a cure in that it reverses the first-place problems causing the dysfunction— the most desired win-win outcome coveted by men with ED.

But board-certified urologists advise men to seek help from ED to do their homework before they leap into new treatments not yet approved by the FDA.

Society warns men shockwave treatment isn’t FDA approved


On March 22, the North America Sexual Medicine Society, Inc. (SMSNA) released a statement advising men seeking ED care that new treatments provided across the country are not licensed by the FDA. “The Society acknowledges the need for adequately driven, multicenter, randomized, sham / placebo-controlled trials in well-characterized patient populations to ensure that any novel ED therapy demonstrates efficacy and safety.”

They went on to list some of the unproven treatments that are being offered, in addition to shockwave therapy: stem cell therapy; platelet-rich plasma (PRP), also known as P-shot or Priapus shot; and other agents such as amniotic fluid.

The SMSNA believes these treatments could potentially restore natural function and “regenerate erectile tissue.”

“There is robust basic scientific evidence. supporting the ability of shockwave therapy and stem cell therapy to improve erectile function; however, to date, there is a lack of clinical trial data supporting their effectiveness and long-term safety in humans.” Any therapy available to help men with ED problems would have an undeniable quick-fix type of appeal, but experts warn that the technology is being used to help them.

SMSNA believes that the use of shock waves, stem cells, and platelet-rich plasma is experimental and should be conducted under research protocols in accordance with the approval of the Institutional Review Board, 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.

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Bob Dole breakthrough


Let’s just back up. Formerly the U.S. Senator and presidential candidate Bob Dole of 1996 who was the first Viagra pitchman for Pfizer to come into our living rooms 20 years ago.

Known for his daunting rehabilitation from wounds he received during World War II, Dole had been subjected to prostatectomy in 1991 while serving as a senator from Kansas State. The surgery stemmed from the personal ED problems that he addressed to the chagrin of those watching television with their parents or grandparents.

“You know, talking about ED is a bit embarrassing, but it is important to millions of men and their partners,” he said in describing why he spoke about the condition publicly.

How far have we gone in these last 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 founder of San Diego Sexual Medicine, is a trailblazer in the area of sexuality for men. He clarified that Viagra, the omnipresent blue pills which serve as the current ED treatment, is not a panacea.

“Pills are not functioning for everyone, and they are incredibly expensive,” Dr. Goldstein said. “They[ interfere] with certain health conditions, and for various reasons, many men discontinue using them. But most importantly, they’re temporary, and they don’t change the condition’s underlying pathophysiology. “Dr. Goldstein explained the researchers ‘ motivation for finding a safe and appropriate alternative to pill treatment. “We are introducing a new paradigm of ED treatment through shockwave therapy that appears effective in changing the health of the penile tissue.”

He drove home the point that the U.S. has not given approval to shockwave therapy for treating ED. Food and Drug Administration (FDA) but later this year, he is working towards a clinical trial.

His center has nine ongoing trials in various areas of sexuality and has already completed an open-label pilot study on men with ED with the shockwave device Dornier Aries from Germany by Dornier MedTech Systems. It is still not approved for use outside of clinical trial usage in the United States.

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. 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


FDA spokesperson Stephanie Caccomo confirmed that the only shockwave technology approved by the FDA’s Center for Devices and Radiological Health (CDRH) at this time was the Sanuwave dermaPACE System, a Class II device for use in conditions such as diabetic foot ulcers.

It delivers acoustic shock waves to stimulate healing within the wound tissue. For the condition to be treated any device must be specifically approved. Otherwise, it is being used off-label.

If the public is concerned that unapproved goods are being sold illegally, we allow customers to file reports for claims of regulatory violations on our website.

The only clinical trial in the United States, using shockwave therapy


Low-Intensity Shockwave Safety and Efficacy for Treating Erectile Dysfunction. Current treatment options for non-operative ED include PDE-5 inhibitors (PDE5-i), such as sildenafil (Caverta), tadalafil (Tadalista), and vardenafil (Vilitra); vacuum erection devices; intravenous injections (P-shots); intraurethral suppositories; and penile implants.

All of these different treatments try to improve erectile function without really addressing ED’s underlying pathophysiology, which leaves the question as to whether we can really cure the damaged penis unanswered.

Dr. Ramasamy said that his clinical trial was planned for 80 people and that he currently has 66 patients enrolled at their University of Miami site in that quest to find out if this procedure will be viable in the long run.

“Patients are paying $3,000 for medications that are not FDA-approved, and if they apply for our trial, it is free,” he said, though the trial is not funded by industry. Dr. Ramasamy said that private donors and philanthropic support are supporting this current trial, although the manufacturer, Direx Medical Systems Ltd., from Israel, has given him two devices.

Potential participants must satisfy the following criteria to qualify for the trial:

● Be a man aged between 30 and 80
● Have ED that lasts longer than six months but not more than five years
● Have had a healthy sexual relationship more than three months before you enrolled

When asked whether the qualification mark of 80-year-old was a bit on the high side, and also about “Mrs. Eighty, “Dr. Ramasamy responded quickly:” That’s not true; we live in Miami, where sex is of paramount importance to all men whatever their age. We’ve had frustrated patients who are 84 and 85 years of age call us to ask why the threshold is 80, and I feel bad for them but that’s in our requirements for clinical trials. Maybe we could design it to go to 90 “in the next trial.

Dr. Ramasamy said his next experiment will be a placebo trial where a sound will be heard by the patient but the real shock waves will not be delivered. “We first wanted to do this trial to ensure it works — and it does,” he said.

Differences in wave energy


Shockwave therapy for the treatment of ED, he noted, is quite different from extracorporeal shockwave lithotripsy (ESWL) used to treat kidney stones, a procedure that people either have performed in the last three decades or at least have heard of.

“ESWL has a smaller focal range and the energy is focused at one level, as opposed to ED where the shock waves are radial, the field is bigger and the energy is distributed over that larger area,” explained Dr. Ramasamy. “In addition, the energy for kidney stones is about 10 percent of what we use for ESWL.”

Dr. Ramasamy was asked whether it was possible for the machine to titrate the dosage alone or whether it had a built-in governor to keep the energy at a certain level, 10% of what is used for kidney stones. “We keep all maintenance records in a format that is required by FDA,” he said. “The system is at a point of shut-off. You can keep turning the knob as much as you want and the speed will not be higher. Turn off the unit— like a hot water heater in your room.

At the end of the numerous clinical trials to be carried out in the United States by urological centers, Dr. Ramasamy said an ideal regimen will be known, but only after a lot of documented studies on a lot of subjects.

“In the meantime, men seeking ED services should be very aware of non-doctors and chiropractors treating patients with what they say is shockwave therapy but is in fact an acoustic vibrator,” he said. “Women are vulnerable and will do whatever to have sex; men are willing to do whatever they can to obtain an erection. It’s critical that physicians and the medical community keep an eye on what’s right.

Shockwave therapy is the only existing ED horizon medication that could provide a cure which is the most desired outcome for people with ED. It has also been proposed that shockwave therapy boosts the efficacy of pill therapy on nonresponders, eliminating the need for more aggressive procedures. Many single-arm studies on patient-reported erectile function scores showed the value of shockwave therapy. However, results from randomized trials appear conflicting, and questions remain to be addressed until this treatment can be regularly given to people.

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