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"The sole clinical trial using shockwave therapy in the United States" (healthline.com)

Jul. 9, 2018

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.

Ranjith Ramasamy, MD, assistant professor and director of reproductive urology at the University of Miami, is the principle investigator on an ongoing clinical trial in the United States.

“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.”

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.

Ranjith Ramasamy, MD, assistant professor and director of reproductive urology at the University of Miami, is the principle investigator on an 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.”

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.

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

RenovaED is in use by Dr. Ramasamy at the University of Miami as part of the current clinical trial to study shockwave therapy for erectile dysfunction.

 

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 non-responders, reducing the need for more invasive treatments. Several single-arm trials have shown the benefit of shockwave therapy on patient-reported erectile function scores.

Full article, can be found at below link.
https://www.healthline.com/health-news/shockwave-therapy-for-erectile-dysfunction#10:

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DirexGroup specializes in introducing innovative high-technology devices for urologists in all worldwide markets. DirexGroup, established 35 years ago, has continuously extended its worldwide presence in numerous countries and markets. DirexGroup has put its emphasis on the field of urology and offers urologists and medical centers various equipment and service solutions to their clinical and economic needs. Our products are characterized by reliability, modularity and transportability combined with cost effectiveness and ease of use. A worldwide network of committed service centers assures competent support and maintenance. Contact DirexGroup at: info@direxgroup.com