The Science and History Behind Shockwave Therapy for Erectile Dysfunction

What’s up, everyone? It’s Rich, and I’m back in full force! I hope you’re ready for an eyeful because I have a lot to say in this post! We’re talking about low-intensity extracorporeal shockwave therapy for erectile dysfunction (Li-ESWT for short) and its current position as a pending treatment for ED.

It’s come to my attention that there’s a lot of misinformation and contradictions across the web about:

• What shockwave therapy is

• The different types of shockwaves (not all shockwaves are created equal)

• What Li-ESWT does for men with erectile dysfunction (ED), Peyronie’s disease, CPPS, etc.

• What the current literature on shockwave therapy for ED states

• What Urologists and people from the medical community say about this type of therapy

• What other websites and clinics you find on the web that offers Li-ESWT say

• Realistic and unrealistic expectations of Li-ESWT treatment from the health clinics and at-home devices

I’ve much more to say than the list above, but it’s important to expose the truth behind Li-ESWT so that you guys can understand exactly what you’re paying for and what it’s supposed to do for your penis.

I’m also pretty sure I’m going to royally piss off some men’s health clinics, as well as marketing teams. But the truth is, they’re a big part of the reason for much of the confusion on the topic.

So, let’s dive in…

But first, READ my disclaimer.

Bdestyle.com, (We, I, Us) is a professional review site that tests men’s health products thoroughly and provides educational information that shouldn't be misconstrued as medical advice. We are independently owned, and the opinions expressed here are our own. We are NOT doctors. We can’t diagnose you. If you need a diagnosis, prognosis or medical advice, go to your doctor. Read more about our policies and disclosures here.

Why Do We Need to Review Li-ESWT Literature?

Another important message: I’m reviewing the literature on shockwave therapy for ED because most of you emailed me about vague, inaccurate, or inaccessible information. So, I'm doing this comprehensive research for you, guys.

Some research on this topic requires fees to access databases and view current clinical trials and data on shockwave therapy. There are, however, ways to access most of this data for free.

I always suggest looking into Pubmed, NCBI, ResearchGate, Onlinelibrary, The Journal Of Sexual Medicine, and other publications to perform simple search queries to find and read the FULL studies on this topic.

This post will not include every study on shockwave therapy for ED, Peyronies, and CPPS. However, I’ll put emphasis on two meta-analysis studies that used focused shockwaves (not radial).

The analyses review and compare over a dozen studies in the past 15 years and hold the most data on the efficacy of treating vasculogenic ED for patients with mild to moderate ED.

The two meta analyses’ I will constantly be referring to are:

1. https://pubmed.ncbi.nlm.nih.gov/27321373/ (Free version here)

2. https://pubmed.ncbi.nlm.nih.gov/27986492/ (Free version here)

I’ll also include certain studies on rats. The value of these studies versus the studies on human males is that there’s no psychological component in animal studies.

Whether you want to believe it or not, if you have any of the types of ED (vasculogenic, neurogenic, pharmacological, hormonal, etc.), you most likely will develop psychological ED due to the frustration, stress, shame, and frequency of these erection issues.

These animal studies also hold interesting data on nerve regeneration.

Lastly, I’ll also include research and discussion on radial shockwave therapy as there is currently “limited information” on radial waves being enough to treat vasculogenic ED (because it’s still new, coupled with contradictions and additional questions).

If you're unsure what I'm referring to, I've also done a full review of the difference between radial and focus shockwave therapy for ED, so make sure to check that out.

But, since I’m a believer in science and continuous research, I think in the next ten years, we’ll have more data and research on shockwave therapy as a whole to reflect on this so we can have standardized approaches when considering each wave type and device as a potential regenerative ED treatment option.

Is Shockwave Therapy For ED Approved in the U.S.?

I must say this here… Li-ESWT is currently not approved as a treatment option for erectile dysfunction and other sexual health-related issues in the U.S. Because we need more reliable research, it’s still considered investigational.

It was, however, approved in Europe in 2021. Still, it must be coupled with counseling and proper screening, and the patient must be informed that success isn’t guaranteed. This is because the patient could have other types of ED or a severe case of ED.

It appears that the FDA in the U.S. is more uptight, and they have every right to consider the limitations and questions that still need to be answered from the Li-ESWT research to date.

But, with the current data, there is potential in this treatment, and it can help men with vasculogenic ED (only), early onset Peyronie’s disease, CPPS, and other sexual health issues.

Glossary of Terms

Let’s look at the scientific terminology to help you understand the discussion we’ll have on this type of therapy.

• Li-ESWT - Low-Intensity Extracorporeal Shockwave Therapy

• fESWT - Focus Extracorporeal Shockwave Therapy

• rESWT - Radial Extracorporeal Shockwave Therapy

• IIEF-EF Score - International Index Erectile Function (Used during studies to determine success)

• IIEF-5 - An abridged version of the IIEF Score that only includes five questions

• EHS - Erection Hardness Score (used during the studies)

• AWT- Acoustic Wave Therapy (a layman’s term for shockwave therapy)

• Linear Shockwave - A different type of shockwave (people confuse this and focus shockwaves — but they’re different)

• Sham - A “control group” where a doctor/researcher doesn’t administer the actual real treatment (not to be confused with placebos used in pharmacological studies...the term sham is often used for non-pharmacological studies —as we are reviewing studies on testing devices and not pills)

• RCT - Randomized Control Trials (Researchers prefer these and double-blind studies for clinical trials to compare an intervention group and a placebo control group)

• PED5i - Phosphodiesterase type 5 inhibitor — ED pills such as Viagra

• EFD - Energy Flux Density — EFD is related to the energy of the shockwave

This list is not exhaustive of all the variations and keyphrases used in the studies or the mainstream, so do your research and make your own conclusions!

Now that we got this out of the way, let’s take a look at the history behind shockwave therapy. Most people think this is a new treatment option, but it’s been around longer than you think!

You guys can save the infographic below for quick reference if needed!

The History of Shockwave Therapy

Low-intensity extracorporeal shockwave treatment ( Li-ST) for men’s sexual health has rapidly gained traction in the last decade. But shockwaves have been used in medicine since 1980.

However, this type of treatment traces its roots to the 1950s, when there was a surge of research into shockwave use in medicine. Ceramics were disintegrated by shockwaves when shot through water in laboratory tests. Frank Rieber of New York was the first to apply for an electrohydraulic shockwave generator patent.

adaptation of the graphic used

Between the 1960s and 1970s, the German Department of Defense researched the effects of shockwaves on animals. Following successful animal testing, shockwaves were used to disintegrate a kidney stone in the first human patient in 1980.

After this initial use in humans, shockwave treatment for kidney stones became the norm. For the next decade, shockwave machines were tested and used to cure orthopedic disorders such as non-union fractures, pseudo-arthroses, osteochondrosis, and various tendinopathies.

In 2010, Vardi et al. demonstrated in a pilot study that low-intensity shockwave lithotripsy (LiST) treatment (energy of about 10MPa) improved erectile function in men with vasculogenic ED. He followed up his findings from 2012 with a randomized, double-blind, sham-controlled study, showing again that LiST benefits people experiencing erectile dysfunction.

In the last ten years, there have been high-quality, randomized studies supporting the effectiveness of LiST in treating ED and, in some cases reversing it. As more studies are conducted, LiST has become an exciting way to help treat ED.

What Is a Shockwave?

A shockwave is a type of energy transmitted through water or air. It is created when a device emits an intense burst of energy. This energy travels until it encounters an object and is then reflected.

Extracorporeal shockwaves (ESW) are acoustic pressure waves. Shockwaves are different from ordinary acoustic waves since they have a lower frequency. A smaller, everyday version of a shockwave is created by clapping your hands.

So, what does that look like with ESWT treatment?

ESWT treatment involves using low-energy waves that go through a person's skin with the help of a transducer. A gel is used as a medium, making treatment painless, so no anesthesia or medication is required.

By stimulating the body's natural healing mechanisms, shockwave therapy could help to repair tissue and reduce pain.

How Shockwave Therapy Works On Penile Tissue

Based on the current research on treating erectile dysfunction, Li-ESWT is supposed to aid the release of vascular endothelial growth factor (VEGF) and nitric oxide, key mediators in collateral blood vessel formation and angiogenesis.

It's suggested that Li-ESWT can cause continuous stress and microtrauma on targeted tissue. This results in a flood of biological reactions releasing numerous angiogenic factors. When this happens, it triggers tissues to neovascularization and vasculogenesis, activating the body's tissue repair response.

Through enhanced macrophage activity, alteration in cellular apoptosis, and synthesis of cellular proteins. Through ED experiments performed with animals, Li-ESWT shows promising results in restoring fibromuscular pathological and endothelial dysfunction.

How Shockwave Therapy Potentially Helps With ED and Other Sexual Health Issues

There’s a consensus that endothelial dysfunction factors heavily in developing ED. It’s believed that reduced blood flow causes cavernous hypoxia and trophic changes in the cavernosal muscles that run through the shaft of the penis.

So, what does this mean? Let’s break it down.

Endothelial Dysfunction and ED

Each part of the body relies on a healthy endothelium to function properly. The endothelium is a thin layer of cells that lines the inside of blood vessels. It’s important in regulating blood pressure, blood clotting, and inflammation. When the endothelium is damaged, it can lead to various health problems.

The cavernosal smooth muscle cells within the penis rely heavily on a healthy endothelium. When the endothelium is damaged, it can no longer provide optimal support for the smooth muscle cells, which can lead to progressive damage and, eventually, ED.

There are several ways that endothelial dysfunction leads to ED. One way is through reduced arterial inflow. When there is less blood flowing into the penis, it can result in cavernous hypoxia and subsequent trophic changes within the smooth muscle cells. These changes can lead to impaired erectile function.

Another way is by increasing inflammation within the penis. Inflammation occurs because of the abnormal regulation of blood pressure and can damage the endothelium and disrupt its normal function.

Lastly, endothelial dysfunction is strongly related to hypertension, diabetes mellitus, ischaemic heart disease, and congestive heart failure, which can all be connected with erectile dysfunction.

The Goal Of Li-ESWT Becoming A Potential Treatment For Men With ED

The ultimate goal of Li-ESWT becoming a regular treatment for patients with ED (consensus from what I’ve gathered after reading multiple studies) is that they want:

• Patients who are not currently responding to PED5i’s (Cialis, Viagra, etc.) to become responsive

• Patients who are responsive to PED5i medication and hate the side effects, to wane off or rely less on them

In these studies, the International Index of Erectile Function (IIEF), IIEF-5, and EHS points are used to determine success in erectile improvement. If a patient moved from an EHS score of 2 to a 3, researchers consider it successful. An EHS score of 3 or 4 should mean a patient can successfully penetrate their partner.

Some studies suggest the potential to reduce plaque calcification or scar tissue in the penis from trauma or acute Peyronie’s disease.

There is also data on Li-ESWT being a treatment for Chronic Pelvic Pain Syndrome associated with sexual health issues.

Because shockwave therapy shows many potential benefits, there are questions about the protocol given to the patient. The wave type and device need more research before FDA approval. I’ve personally read a lot of studies, and the majority seem to conclude that more research is needed.

Which Shockwave Devices Have Been Studied?

The shockwave devices used in the studies (most researchers usually reference the Focus shockwave devices) are:

Electrohydraulic systems

• Omnispec ED 1000 (Medispec, Gaithersburg, MD, USA)

• Urogold 100 (MTS Medical, Konstanz, Germany)

Electromagnetic systems -

• Dulioth SD1 (Storz Medical AG, Tägerwilen, Switzerland

• Aries (Dornier MedTech GmbH, Wessling, Germany)

• Renova and MoreNova (Direx System GmbH, Wiesbaden, Germany

Piezoelectric systems - piezoelectric crystals are arranged in a spherical shape to focus energy.

• PiezoWave 2 (Richard Wolf GmbH, Knittlingen, Germany)

Is There Enough Research On Li-ESWT For Erectile Dysfunction?

When it comes to these studies, they need to be broken into two different groups as there is Focus shockwaves and radial shockwaves.

For focus shockwave studies, there is enough supporting evidence because researchers investigated these devices first. However, because each research design used different protocols, devices, energy signatures, follow-up procedures, sample populations, and other variables, there’s not enough evidence for the FDA to approve it in the United States… yet.

As far as radial shockwave therapy for ED goes, there is limited data that can answer these questions, especially since the majority of clinics in the U.S., Canada, and other countries offer radial wave therapy as well.

How Are Men Continuously Getting Successful Results With Radial Wave Therapy in Clinics?

Think about it. There must be some reason considering this has been going on for over a decade.

Maybe it’s because it can, in fact, penetrate deep enough depending on the bar/energy (I covered this in my research on the differences between radial vs shockwave therapy and there is evidence showing that it can reach deep into a flaccid/erect penis). Or maybe the threshold of having the physiological response from Li-ESWT is lower than we thought in terms of energy or megapascals or the type of device, or the shockwave system employed.

This, to me, still needs to be investigated because there is no concrete evidence on how many megapascals a radial device can reach. It is only speculated that it can only reach 0.1 to 1.1 MPa (Megascapal), which is actually a “generalized” range for more than one radial device. So, this in fact, is not an exact approximation when there are some studies that show it can reach 5 MPa and others suggesting up to 30 MPa if we look into studies for orthopedic/superficial injuries.

Energy parameters are 6 dB and the 5 MPa focus (According to Storz, no study shows the magic number “5 MPa” as the threshold for seeing the biological/physiological effects from Li-ESWT. It’s only assumed).

The 6 dB zone is often reported in studies and refers to the focal zone where pressure amplitudes of at least 50% of the maximum pressure are reached.

According to current knowledge and opinion, the figures of the focal zone do not provide any information about the real therapeutic impact zone of shockwave treatment.

Now, let's look at what has been investigated in Li-ESWT research…

Review of the Two Meta-Analysis On Shockwave Therapy For ED

These two meta-analyses on the current research are robust enough to prove that shockwave therapy shows evidence for treating mild to moderate ED (and, in some cases, for moderate to severe ED).

It’s important to show the findings and limitations of these research studies because not every men’s health clinic or urologist points out every fact from the discussion and conclusion section of the research.

Meta-analysis 1

This meta-analysis evaluates the therapeutic efficacy of LI-ESWT for treating patients with ED. The literature review is aimed at physicians who may be considering offering this treatment option.

The review draws on studies found in the Embase and PubMed databases up to November 2015. In all, there were 14 studies which included 833 patients. These studies were carried out between 2005 to 2015.

Findings

Of these 14 studies, half were randomized controlled trials with variable treatment protocols and parameters. The studies showed that LI-ESWT improves IIEF scores significantly, with an average increase of two points, with improvements that last for at least three months.

The studies also showed that patients with mild to moderate ED improved more than those with more severe presentations or additional problems/comorbidities (example: a health condition like diabetes limits success because conditions such as this, impairs blood flow to begin with).

Factors that affected the clinical outcome included the number of shockwaves used, the energy flux density, and the treatment duration.

The EFD (energy flux density) ranged from .09 to .25 mm/mj^2 in these studies.

Conclusions

The analysis concluded that LI-ESWT for ED shows promise as being a suitable first-choice treatment option. The review recommends longer-term follow-up analysis as this would provide confidence in this treatment method. The conclusion suggests further studies specifically evaluate shockwave use in conjunction with medication and how it helps patients of specific ages and those affected by different ED causes and comorbidities.

Meta-Analysis 2

This meta-analysis evaluated and compared the findings of seven studies performed between 2010 and 2016. The studies were found through systematic searches on the MEDLINE, EMBASE, and ClinicalTrials.gov databases.

The reason for the analysis was to assess the effectiveness of Li-ESWT for ED using the IIEF-EF score. The studies used compared Li-ESWT and sham therapy.

The seven studies was based on a total of 602 participants using a randomized control trial format. Across these studies, the average participant was 60.7 years old, and treatment follow-ups were performed an average of 19.8 weeks later.

Findings

As with the previous meta-analysis, significant improvements were found in IIEF-EF score in Li-ESWT compared to sham therapy. Additionally, there were differences found in relation to the number of shocks received.

Conclusions

The conclusion of this research is that Li-ESWT provides an improvement in the IIEF-EF score of study participants. The researchers believe this study was a success and acts as an example to improve future studies. Researchers propose longer followups than 3 months and they also suggest dopplers to ensure that only vasculogenic ED candidates are considered as this treatment is meant for this cause as opposed to other types of ED (eg. neurogenic ED)

The Importance Of The Shockwave Therapy Rat Studies

Although these studies weren’t on humans, the significance is that there are none of the psychological components present in the tests that men face in the bedroom (performance anxiety, etc.). Instead, the rat studies examined shockwaves in relation to diabetes-related ED.

This study evaluated the erectile performance of 24 rats. A control group of 8 received no treatment at all. The remaining rats were given streptozotocin, a drug used to induce diabetes in rodents. 8 of these rats received shockwave therapy, and a second diabetic control group of 8 did not.

The group receiving shockwave treatment received 300 shocks of 0.1 mJ/mm at a rate of 120 per minute.

The rats that had the shockwave showed favorable results and a reduction in diabetes-related ED.

Another study found similar results. This time, rats were grouped into normal control, diabetic control, and three groups of diabetic rats received three different shockwave doses.

The study identified that 300 was the optimal number when it came to shockwave therapy.

The Studies On Radial Shockwave Therapy For ED Done So Far

While researching all the wave types used for ED, I could only find limited research on radial therapy. Here are the links to these studies:

This Czech clinical analysis of the BTL – 6000 SWT device used 22 men with vasculogenic ED who all responded well to erectile dysfunction medication.

A 2019 study compared focused and unfocused ESWT in the treatment of erectile dysfunction. Using two groups of 20 participants. One group received focused ESWT; the other received unfocused ESWT. In this study, those receiving unforced ESWT saw the biggest improvement.

This 2019 literature review found radial shockwave treatment to be a safe and effective treatment option for erectile dysfunction.

In 2018, a study of 29 men was held. All of the participants had lower urinary tract symptoms and suggestive benign prostatic hyperplasia. The men were not good candidates for surgery and responded poorly to medical therapy.

The participants were treated using radial shockwaves weekly for eight weeks. The men received 2000 impulses at 2.0 bar and 10 hertz of frequency. The device used for the study was a standard ballistic shock wave device with a radial shock wave source (STORZ MASTERPULS® MP100)

The participants were measured against the International Prostate Symptom Score (IPSS), quality of life (QoL), and International Index of Erectile Function-5 (IIEF-5) before and after the fourth and eighth rounds of treatment and again three months later. Also assessed were peak urinary flow (Qmax) and postvoid residual (PVR).

The study found improvements in all areas, and the results were sustained for up to three months after the trial.

One side effect was noted; pain or discomfort in the perineum (the area of skin between the back of the scrotum and the anus); however, this subsided after three days.

The study concluded that radial shockwave treatment is both safe and effective.

What is Needed For The Future?

Personally, I don’t think it’s fair to rule out radial therapy just yet. A good majority of clinics in the U.S have been offering radial wave therapy using devices like the Storz D-Actor model, The Zimmerman, and other models for years (emphasis on this… because we are now in 2023 and this is no longer considered a new treatment), there needs to be MORE studies on these devices across the board.

For instance, the energy signatures and penetration depth are less than focus shockwaves. This makes me question why the current studies on radial wave therapy used similar protocols as the focus wave studies.

You can imagine why there is an uproar in the medical community about radial versus shockwave therapy regarding the position of this restorative treatment in the United States.

What Men Should Expect From Shockwave Therapy In A Clinical Setting

If we go back to the universal issue of this type of treatment, there is not enough supporting data in the eyes of the FDA to approve Li-ESWT for treating ED and other men’s sexual health issues. So, because of this, it’s suggested to get this type of treatment by participating in a clinical trial because there is still ongoing investigation on this treatment option.

But, because there is a lot of optimism around this treatment and there is a lot of good data on this so far, including anecdotes about the success of thousands of men from clinics throughout the U.S, more and more men’s health clinics are going to keep popping up and offering this type of therapy, but at a premium cost.

Most clinics charge at least $500 dollars for a single treatment. Some even sell packages with 6 to 12 treatments (costing between $3000 and $6000). This is because they consider 6-12 treatments as a threshold for the average guy to see successful results.

This “secret shop” study into the cost of shockwave therapy found the average treatment course was $3,338.28. Out of 152 clinics, 25% were urologists and 13% were not physicians.

The Argument On Focus Shockwaves Versus Radial Shockwave Therapy

You will often see other websites trying to critique the differences between radial versus focus shockwave therapy when they have no clue or experience with every device on the market.

Again most MDs, PAs, RNs, and others in the medical community are going to push you to come into their center for Shockwave therapy because it’s a “power” move. They’re only relying on the current data, or rather, the data from 2010 to 2016, when we all know that there’s still ongoing research.

Like I’ve said before and I’ll say it again, research is continuous. What we have so far is not the “end all” discussion. I’m going to give some of these doctors the benefit of the doubt, but the rest is most likely in it for the financial reward and thinks we, “the consumer”, are not smart enough to actually go on Pubmed, NCBI or any of the other research sites to learn more about this type of therapy and make our own decisions.

At the same time, some of us are at a certain age where we don’t have that much time left to actually resume a “quality” sex life. Sexual health will decline even further making it almost too late to even see if this could actually help as these populations of men will be in the final stages of their lives (Yes, this sounds dark… I know).

What About At-Home Shockwave Devices? Is There Any Science Showing That We Are Ready For Those?

What you should expect is a rise and fall of "fake" at-home shockwave devices in the next 5-10 years (just speculating). There are plenty of marketed “shockwave” devices floating around on the internet on Amazon, Walmart, eBay, Aliexpress, and other places where the descriptors are not accurate at all.

Let me teach you guys about “Drop shipping” in a blog post I wrote about fake at-home shockwave devices to watch out for. I bet you 5 bucks that a guy or woman in their basement who is listing products and devices on eBay has NO IDEA what Shockwave therapy is and is copying and pasting whatever description they find online to gain maximum reach for their listing.

The point is… Don’t fall for these 3rd party sites that offer these devices that have not been regulated or registered with the FDA. You literally get what you pay for.

The Only Li-ESWT Device On The Market For Home Use Is The Phoenix

Currently, the only at-home Li-ESWT on the market is The Phoenix. Their device is currently being regulated by the FDA and is registered as a medical device on their website.

It has also been out since 2019/2020 and has gained a lot of traction and credibility from hundreds of reviews of The Phoenix, 3rd party reviewers, as well as partnering urologists that use The Phoenix in their clinics. They also have a protocol created by their partnered urologist named Dr. Paul Thompson, which is designed to maximize results.

Closing Thoughts Of My Research On Shockwave Therapy For ED & What The Future Holds

I am a glass half full type of guy. I believe there is strong research on this type of therapy. But we just need more of a uniformed approach and additional randomized/double blind studies.

This includes:

• Protocols for each and every device

• MORE research on both energy signatures and the different wave types (more radial and focus wave studies)

• How this treatment option should be marketed considering there are multiple phrases for this treatment that contributes to more confusion

For this reason, I am hopeful this type of therapy will become FDA approved in the U.S. in the near future and we’ll have more specific protocols for each brand of device out there, including data from at-home devices like The Phoenix.

I am also well aware that I didn’t answer every question entirely as again, there is conflicting information online about the mechanisms behind what shockwaves actually do and the limited information on radial wave therapy.

At the same time, there is a lot of noise among the medical community as we saw in an article from The Philadelphia Inquirer. Which was referenced in my comparison of radial and focus shockwave therapies about the optimism of some doctors and the pessimism of others who would rather push PED5i’s and injectables (trimix) rather than help bring men a treatment option that could potentially help reverse the leading cause of ED (vascular ED).

Lastly, I may not be the first, but I will definitely not be the last to write on this topic. I just hope anyone reading this will see hope in the research and the possibility of this becoming a regular treatment option in the future. As for you content scrapers, I dare you to rewrite this whole thing (I have eyes everywhere and will virtually “jab, cross, hook” you).