What is it?
It’s the application of low-intensity shockwave to restore normal erectile function. ED is a degenerative process of the human flesh, the erectile muscle shrinks, loses compliance and elasticity and the thick layer that holds the muscle together called the tunica albuginea deteriorates, becomes abnormal and stiff. The theory behind the use of low-intensity shockwave is that it can restore normal penile muscle and tunica.
Types of shock wave machines?
“There are two types of shock wave machines:
The SwissWave, which is a class 1 medical device that’s offered throughout the country by chiropractors and the like with claims that it improves erectile dysfunction. Because it’s a class 1 medical device, they can offer this to patients and administer it without a worry from the FDA. This type of machine delivers a shock which is very shallow and of insufficient energy to do anything to any kind of scar tissue in the penis. There is zero medical literature supporting the use of this type of shock wave therapy for problems with erection.
The class 2 shock wave therapy devices are FDA regulated and cannot be used outside a clinical trial. Those are the real machines that actually deliver shocks.
Men seeking treatment with a shock wave therapy should find out which class of medical device is being offered by the clinic advertising such a treatment.
Good researchers are working on studies with class 2 shock wave devices and the results are not out yet. Researchers don’t yet know if shock wave works at all, and neither for what group of patients may it be beneficial nor for how long it would work for. Until more work is done, men should not spend their money on it. More trials are needed. Currently there is very limited data in the U.S. and FDA approval for class 2 shock wave therapy device for the treatment of ED is likely years away.
American Urological Association (AUA)
According to the American Urological Association guidelines, low-intensity extracorporeal shock wave therapy should be considered investigational for men with ED. Patients who wish to seek shock wave therapy for ED should look for clinical trial opportunities and enroll in one at no cost.
Sexual Medicine society of North America (SMSNA)
“Thus, given the current lack of regulatory agency approval for any restorative (regenerative) therapies for the treatment of ED and until such time as approval is granted, The Sexual Medicine Society of North America believes that the use of shock waves or stem cells or platelet rich plasma is experimental and should be conducted under research protocols in compliance with Institutional Review Board approval,” according to the statement. “Patients considering such therapies should be fully informed and consented regarding the potential benefits and risks. Finally, the SMSNA advocates that patients involved in these clinical trials should not incur more than basic research costs for their participation.”