Linear Focal Acoustic Therapy

New curative treatment for erectile dysfunction

Erectile dysfunction

Treatment options

Existing

Oral medication (little blue)
Injection of vasodilator drugs into the penis
Vacuum pump
...

Disadvantages and problems

Side effects of oral drugs (little blue)
They only treat the symptoms
They're expensive over time (they don't cure, they just work for as long as the drug has an effect)
Lack of spontaneity
Reduced self-confidence
Psychological problems
...

Erectile function

Healthy blood vessels matter!

Erection is the result of a complex synergy between blood vessels, the nervous system, hormones and muscles. During erection there is an increase in blood flow to the penis, which leads to a rise in intra-penile pressure. Adequate blood flow into the corpus cavernosum (penis) is essential for good penile rigidity.

Arterial Factor in Erectile Function!

A decrease in arterial flow to the penis generates a reduction in venous compression, resulting in a loss of penile rigidity. Arteriosclerosis is one of the best-known causes of this reduction, leading to erectile dysfunction.

Risk factors

Smoking
Diabetes mellitus
Hypertension
Hypercholesterolemia (high blood cholesterol levels)
Chronic kidney disease

Linear Acoustic Waveform with Tissue Coverage for Erectile Dysfunction (LSTC-ED)

A unique therapy concept
Treatment of erectile dysfunction using piezoelectric focal acoustic waves.

The LSTC-ED technique is a quick and painless treatment that manages to cover the entire corpus cavernosum. The wave-generating source is placed over the corpora cavernosa and moved longitudinally along the penis (corpora cavernosa) and perineum (crura peniana ). This results in a maximum, homogeneous, rapid transfer of energy, requiring only a few minutes to apply.

Treatment

The treatment is done in the office, without anesthesia. It is completely painless and only takes a few minutes.
The applicator is positioned over the corpora cavernosa and moved longitudinally along the penis.
The treatment is administered in 1-2 sessions / week. A total of 4-6 sessions are carried out. There are no known side effects.

Mechanism of Action!

Specific mechanical stimuli can influence the cellular functions of living tissue. The extracorporeal shock wave, a modern treatment established in medicine for over 30 years, activates mechanical sensors that trigger tissue biochemical changes.

Shockwave effects:

Angiogenesis (appearance of new blood vessels)
Improved microcirculation
Relaxation of blood vessel smooth muscle (allowing more blood to enter the penis)
Activation of local stem cells
Improved nerve transmission in the penile nerves

Credibility and scientific evidence are important!

We have dozens of published medical studies, with meta-analyses, giving a 1A level of scientific evidence for the use of low-intensity shockwaves.
A multicenter study carried out in Germany with 75 patients using Piezowave2 showed a success rate of 81,3%.

Treatment of Erectile Dysfunction with PiezoWave2 Device. Application of Low Intensity Shockwaves Using Novel Linear Shockwave Tissue Coverage (LSTC-ED®) technique. A Prospective, Multicentric, Placebo-controlled Study.
Dr. Motil I. 1, Dr. Kubis I. 2, Dr. Sramkova T. 3

Book your appointment now

Click here

New Piezowave 2 machine. 15.5X greater volume of fabric treated than a conventional machine!

Faster and more effective treatment, covering much more tissue

Comparison between the areas treated by conventional machines and Piezowave2

Scientific basis and history

INTRODUCTION

Great advances have been made in the understanding and treatment of erectile sexual dysfunction (ESD) over the last two decades. Many patients suffering from ESD respond well to existing treatment options, including oral drugs and injections of vasodilator drugs into the penis. However, these drugs are unable to alter the organic causes of erectile dysfunction. They are generally used on demand, before sexual intercourse, but only temporarily improve the quality of penile rigidity. There is therefore a need for new effective treatments that have lasting effects with spontaneous erections, restoring penile function.

Recently, a promising modality has been introduced: Low Intensity Extracorporeal Shockwave Therapy (LICSWT) on the penis, first performed in 2010.

WHAT ARE SHOCK WAVES?

Shock waves are acoustic waves that generate a pressure impulse. These waves carry energy as they propagate through a medium. The degree of intensity of the machine can be modulated non-invasively, resulting in variable energy concentrations at the desired location. When shock waves are applied to an organ, the wave interacts with the target tissue deeply and acts as a transient micromechanical force, which initiates various biological changes.

WHERE ARE SHOCK WAVES USED IN MEDICINE?

Shockwave therapy has been studied and applied clinically in various fields of medicine. High-intensity shockwaves are used to break up calculi, due to their focal destructive nature, and were first used clinically in 1980. Medium-intensity shockwaves have been shown to have anti-inflammatory properties and are used to treat a variety of orthopaedic diseases, such as fractures that do not consolidate, tendonitis and bursitis. Low-intensity shockwaves have angiogenic properties (stimulating the creation of new blood vessels) and are usually used to treat chronic wounds (difficult to heal), peripheral neuropathies and ischemic heart tissue (with poor blood supply).

Shockwave breaking up a calculus inside the kidney (illustrative image)

HOW DOES IT WORK?

When the low-frequency shockwave is applied to an organ, its weak wave interacts with the deep target tissue, where it causes mechanical stress and microtraumas, also known as shear stress. This force triggers a chain of events, which causes the release of angiogenic factors, which create new vessels in the treated tissue, increasing blood flow. In addition, the shock wave has the ability to recruit stem and progenitor cells. These cells have the ability to divide and differentiate into specialized cell types. Their key role in the emergence of new vessels in ischemic tissues has been widely researched. A recent study showed that ischemic tissues (with little incoming blood and oxygen) release chemical factors that are attractive to progenitor cells circulating in the blood. These cells contribute to endothelial (blood vessel lining) repair. Another study showed that the low-frequency shockwave has the ability to activate stem cells within the penile tissue. The end result was increased blood flow in the treated tissue. Another effect of the shockwave is to promote the regeneration of nerves involved in erection.

This figure shows the blood vessels (branches in black) in the limb of an animal exposed to shock waves. The images were taken before and 21 days after treatment. An increase in the number of vessels is visible.

Stem cell activation

Another effect of the shockwave is the activation of stem cells, which are inactive in the penis, especially below the tunica albuginea (corpus cavernosum). The shockwave activates the division of these cells, regenerating the local tissue.

Today the low-intensity shock wave is considered a minimally invasive stem cell therapy.

Reference
Lin G, Reed-Maldonado AB, Wang B, Lee YC, Zhou J, Lu Z, et al. In Situ Activation of Penile Progenitor Cells With Low-Intensity Extracorporeal Shockwave Therapy. J Sex Med. 2017;14(4):493-501.

a) Penis of an animal that did not receive the shock wave
b) Penis of an animal subjected to a low-intensity shock wave

White arrows: Active stem cells (dividing and maturing)

CLINICAL APPLICATIONS OF SHOCKWAVE

Encouraging results tested in animal models formed the basis of knowledge for human studies. Several of them have demonstrated the positive effect of low-intensity shockwave therapy in patients with severe ischemia of the heart. The findings show that shockwave improves the ejection fraction (amount of blood pumped by the heart) and reduces chest pain during exercise.

Another application of the shockwave has been in orthopaedics, for the treatment of damaged muscles and tendon diseases.

In the treatment of wounds, shockwaves have also proven to be extremely effective, accelerating healing and improving ischemia in complex wounds, due to their ability to stimulate the appearance of new vessels and consequently increase vascularization.

Neovascularization: Emergence of new vessels from pre-existing vessels

SHOCKWAVE APPLICATION IN ERECTILE DYSFUNCTION

Since one of the main causes of erectile dysfunction is poor arterial flow, it has been suggested that inducing neovascularization with a low-intensity shockwave could improve arterial flow, thus improving erectile function. The first study to demonstrate the efficacy of shockwave in erectile dysfunction was carried out in 2010 by Vardi et al. In it, the authors applied low-intensity shockwave to 20 middle-aged patients with mild to moderate erectile dysfunction who had improved their erection with oral medication. They applied the shockwave to 5 different places on the penis in 6 sessions.

One month after starting treatment, 75% patients showed a significant improvement in penile rigidity. In addition, nocturnal erections, which occur during the REM phase of sleep, were measured and showed a significant improvement in penile blood flow. Most of the men reviewed, after 6 months of treatment, continued to have spontaneous erections without the need to use oral drugs.

Atheroma plaque obstructing a small vessel in the penis, causing reduced blood flow

Following this encouraging result, other studies were carried out on animals. Several groups evaluated the effect of low-intensity shockwave therapy on the erectile function of diabetic rats. They evaluated the pressure inside the penis after stimulating the nerve that generates the erection. It was found that the erection of diabetic rats was reduced in all animals, but the animals subjected to shockwave therapy showed a much smaller reduction. In addition, analysis of the penile tissues of the animals subjected to shockwave therapy showed a much greater quantity of nerves containing nitric oxide (responsible for relaxing the smooth muscle inside the penis, allowing greater blood flow and penile rigidity), endothelial cells (cells present in blood vessels), smooth muscle cells and mesenchymal stem cells. These findings support the idea that one of the therapeutic mechanisms of the low-intensity shock wave is the recruitment of pluripotent cells, which circulate in the blood system.

Another study, carried out on rats whose nerves involved in erection had been severed, showed that the group that underwent low-intensity shockwave therapy showed regeneration of the severed nerves, the appearance of new blood vessels and increased pressure inside the penis. In addition, they showed a much higher concentration of progenitor cells (pluripotent cells) in the penile tissue.

Vardis and colleagues carried out new clinical studies on patients with vasculogenic erectile dysfunction (low blood supply to the penis). They tested patients who had poor penile rigidity following the use of medications such as azulzinho. The intention was to investigate the possibility of low-intensity acoustic wave therapy converting patients who were no longer "functioning" with the use of oral drugs (little blue) into "functioning" patients, i.e. who would now have good penile rigidity. The study was carried out on 29 patients who had multiple risks for cardiovascular disease, established cardiovascular disease and diabetes. All of them did not have adequate penile rigidity after taking the oral drug. After treatment 72% of them had good penile rigidity with the use of the oral erection drug. This increase in rigidity was accompanied by an increase in the inflow of blood to the penis and better function of the vascular tissues. Another important finding of the study is that no patient reported pain or any adverse event during treatment.

HOW IS SHOCKWAVE THERAPY PERFORMED?

The shockwave is applied to the penis and the crura (base of the penis at the pubic bone), totaling 5,000 pulses per session. There are a total of 4 sessions. They are done 1x/week, for a total of 01 month. At the end of the treatment, 20,000 pulses will have been generated.

Linear focal acoustic wave being applied (illustrative image)

Shockwave inducing neovascularization (appearance of new vessels) (illustrative image)

Book your appointment now

Click here

SCIENTIFIC EVIDENCE

Today we have dozens of studies proving the efficacy of the method in treating erectile dysfunction. Two systematic review and meta-analysis studies are worth highlighting. The first was published in January 2017 in the Journal of Sexual Medicine, the official journal of the International Society of Sexual Medicine (1). The second was published in February 2017 in European Urology, the journal of the European Society of Urology (2). Both confirm the efficacy of shockwave therapy in the treatment of erectile sexual dysfunction, providing level 1A scientific evidence.

1.Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017;14(1):27-35.

2.Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur Urol. 2017;71(2):223-33.

SEE

Read the interview with Dr. Alexandre Miranda