What is LI-ESWT Therapy?

LI-ESWT (Low Intensity- Extracorporeal Shock Wave Therapy) is a relatively new, painless method for treatment of ED. It has been proven, in the past 10 years, to be very effective in improving ED in most men.

The extraordinary feature of LI-ESWT is that it is the first potential non-surgical curative treatment for ED.  Current treatment of ED, using pills or injections, is successful, but has always relied on ongoing management of the condition. That is, anyone using pills or other treatments must plan to use them before each sexual activity. LI-ESWT treatment potentially improves a man’s sexual functioning whenever he is sexually active.  This may allow him to get and maintain a good erection without requiring an immediate intervention, or improve his function so that he can use a less invasive method to be successful (e.g. function with using pills as opposed to injections.)

LI-ESWT treatment is currently approved for ED in Europe, South America, China, and Canada. In the US, LI-ESWT treatment is not currently FDA approved as a treatment method for ED, but Shock Wave Therapy is approved as a treatment for plantar fasciitis. However, there is at least one company that is currently planning a US trial for FDA approval.

How Does LI-ESWT work?

The principle is that shock waves are applied to the penis through a probe on the skin.  It is believed that the shock waves cause mild trauma to the blood vessels, which then release growth factors.  These growth factors stimulate the formation of new blood vessels (neoangeogenesis) as well as repair of the lining of the existing blood vessels (the endothelium.) Other theories suggest that it may break up the plaque blocking the blood flow in small vessels, or it may cause stem cells to migrate to the area, which then create new blood vessels.

Is this treatment backed by research?

There is an extensive body of scientific research17 that shows LI-ESWT’s effectiveness.  The most widely used scale to measure a man’s satisfaction with his erection is called the IIEF-5 (International Index of Erectile Function.)  It consists of 5 questions, with a possible score of 1-5 on each. If a man improves by five points, his erectile dysfunction improves one level, for example “from moderate to mild”.

An aggregate of the major studies (termed a “meta-analysis”), found that an average man’s erectile status improved by a full 5 points (or level) after treatment with LI-ESWT, moving from severe to moderate, from moderate to mild, from mild to normal.

The exciting thing about these studies is the quality of the research design.  The studies are randomized double-blind placebo-controlled (RDBPC’s), which are considered the gold standard in study design. Patients are randomly assigned to the treatment or non-treatment group.  The physicians conducting the study do not know which patient is in which group.  Each patient receives either treatment or a sham treatment, but is unaware of which he is receiving. 

The RDBPC studies performed internationally on LI-ESWT show significant differences between the treated and non-treated group.

How does LI-ESWT compare to other treatments for erectile dysfunction?

The most dramatic difference between LI-ESWT treatment and all of the other (non-surgical prosthesis) treatments is that, if it proves effective for a patient, he will no longer need to rely on pills, injections or other medication each time he has sex.  Or, he may need a less invasive method than he was using previously to get and maintain a good erection.

Who is a candidate?

Most erectile dysfunction is caused by vascular problems. Patients either have a problem getting the blood into the penis (inflow) or keeping it inside the penis (trapping).  The men who are most likely to be successfully treated by LI-ESWT are those who have “inflow” problems. These are men who have decreased blood flow through the arteries into the penis.

However, published studies have also included men with more severe ED, those who have both inflow and trapping issues, and they have also been successfully treated.

One limitation of the research concerning LI-ESWT is that is has not been tested on men with erection issues that are primarily neurologic, such as dysfunction caused by surgery. It is not known whether the LI-ESWT is effective for ED with a neurological cause. However, it is possible that LI-ESWT may still have a positive response on penile nerves.

Is it safe?

Yes. Fortunately, safety is not an issue.  There is no evidence of any short or long term negative effects of treatment.  The only question is whether you will be one of those men for whom it works, but that is the majority of men.

How many treatments would I need?

There are a total of twelve treatments, spread out over nine weeks. Each treatment lasts for approximately 10-15 minutes.

We follow the published protocol which consists of two treatments per week, for three weeks (for a total of six treatments.) This is followed by a break of three weeks.  It is then followed by another set of six treatments over three weeks.

How long do the results of treatment last?

There is no good, long-term data yet, but it appears that most treatments last at least 1-2 years.

Do the treatments hurt?

Most patients describe only a mild buzzing sensation during treatment

I’ve heard of the D‘Actor and the Duolith machines, both made by Storz. Which one is Maze using, and how do they compare?

There are currently only two machines that have scientific studies in peer reviewed journals.  They are the Duolith, manufactured by Storz and used by Maze, and the Medispec ED1000.  These devices both provide direct focused beams. Neither is FDA approved for ED treatment in the US.  However, the Duolith is both approved and being used in Europe extensively for the treatment of ED. It is also approved by the FDA in the US for another condition (plantar fasciitis), which allows us to offer treatment on this machine as “off label use”.

The machine most used in the US, and marketed by a company called Gainswave, is the D’Actor by Storz.  It uses radial shock waves.  There are currently no peer reviewed randomized double-blind placebo controlled (PRRDBPC ) studies using this machine, or any machines that use radial shock waves.  The use of this machine is not approved by the FDA as a treatment for ED in the United States, nor to our knowledge has it been approved as an ED treatment by regulators in any other country.  The protocols advertised for the use of this machine thus have no PRRDBPC studies showing their efficacy. It is questionable whether the waves have enough intensity or penetrate deeply enough into the penis to improve erections.

What are my next steps?

Contact us to find out whether Shock Wave Therapy is the right treatment for you or to schedule an appointment. If you’re missing spontaneity in your sex life or just tired of relying on pills or injections every time you want to have sex, Shock Wave Therapy for ED may be a good choice for you.

IN A PATIENT’S OWN WORDS:

My first impressions of Dr. Werner: smart, caring, confident, warm. He really listened to me and demonstrated a high level of confidence that he could help me. He understood the impact my symptoms were having on my life and didn’t minimize them. Paul (therapist) and Kristy (exercise physiologist) were also professional and inspired both calm and confidence.

I was initially referred to Dr. Werner for ED and began using a combination of medication and penile injections. Once Dr. Werner found the right dose for me, I was able to get the best erection I had had in over six months. I later developed Peyronie’s Disease as well. I was fortunate that Dr. Werner had significant experience treating Peyronie’s Disease, as he was able to assess me and recommend Xiaflex injections. While treating my Peyronie’s, Dr. Werner also suggested I begin Shockwave Therapy to further help my ED. Since completing both treatments, not only has my Peyronie’s seen dramatic improvement, but my ability to get an erection has improved 95%!

I feel very positive about my experience with Dr. Werner and Maze. These are good people and they are good at what they do. They understand the problem, treat you with respect and take your concerns seriously. I can’t imagine there’s any sexual health issue Dr. Werner would not be able to help you with! If you do consider coming to Maze, it’s important to stick with it and remember that these are medical issues and results do not happen overnight. I was incredibly nervous when I came in for my first appointment, but Dr. Werner has created an environment and a team at Maze that will immediately put you at ease.

Additionally, you and your partner must be on the same page since treatment is a process and requires both patience and good communication. I’m happy to say my wife and I have seen tremendous benefits, becoming even more communicative and closer as a couple throughout this process. Two years ago, I never would have believed coming in for treatment would have changed our relationship so positively.

–D, Age 69