People place a lot of stock in FDA (Food and Drug Administration) approval and though shockwave treatments are immensely popular, they aren’t FDA approved. So, what’s the deal? Is GAINSwave Therapy the right decision for treating erectile dysfunction?
There are numerous studies detailing the success of low-intensity shockwave treatments for ED patients. One of the most recent and successful studies was conducted by a team via the National Library of Medicine.
Shockwave therapy has been alive and well for some time now, specifically as a treatment for ED (Erectile Dysfunction). When a treatment is in the mainstream for a long time, users and administrators alike gain a lot of knowledge concerning its efficacy. Scientific studies bolster this information as well.
Shockwave Therapy Explained
Whenever you see the word “shockwave therapy” thrown around in the doctor’s office, it’s usually truncated to an acronym—LiSWT—Low-intensity Shockwave Therapy. This kind of therapy, specifically GAINSwave treatments, is designed to use low-intensity shockwaves that target unhealthy tissue.
The soundwaves pass over and through these tissues and help to repair the cell growth within these tissues and speed up cell growth. So the result is twofold—repair and expedite. The cell tissue in the penis is nothing without blood flow.
This is why things like Viagra and Cialis are so effective. They dilate blood vessels, allowing for more blood flow into the penile tissue whenever you are aroused. However, it’s one thing to improve blood flow, and it’s quite another to repair and reinvigorate tissue at the cellular level.
You can increase traffic on an old road that lacks maintenance. However, you’re inviting an inevitable accident. But, if you improve the roadway, traffic will take care of itself. It’s the same concept here.
When you go to get a GAINSwave treatment, the doctor will use a device to pass over your penis. This device is the source of the low-intensity, high-energy shockwaves that pass through the tissue of the penis. The treatment lasts for about 15 minutes.
The most recommended frequency for treatments is two times per week. However, after three weeks, patients go on a three-week hiatus without any treatments. It’s three weeks on and three weeks off.
If you undergo the treatments routinely and follow the doctor’s recommendations, the treatments should ultimately remain in effect for up to a year.
Studies Showing the Efficacy of Shockwave Therapy
A combined conglomeration of scientific studies and real-life usage are positive factors, proving that GAINSwave treatments can successfully treat erectile dysfunction. The above-mentioned study is only one of many.
Though the FDA has not approved GAINSwave, the science behind it is certainly promising. One thing that the FDA has approved is the Sanuwave dermaPACE System. The dermaPACE is a form of low-intensity, shockwave therapy that improves the healing process in foot ulcers.
One thing this FDA-approved treatment shows is that shockwave treatments aren’t some benign, crackpot magician’s trick. They facilitate healing in the body’s tissues. Additionally, scientific studies and testing of shockwave treatments continue to show positive results as well.
2019 Study in the Sexual Medicine Journal
In 2019, the Sexual Medicine Journal published the results of a series of randomized, controlled trials. The purpose of the publication was to prove the positive possibilities of shockwave therapy and to inform the public, specifically those suffering from ED.
The result was a conglomeration of 47 various clinical trials that overwhelmingly leaned towards the positive effects of shockwave therapy on ED patients. Not only did the Sexual Medicine Journal publish these results, but it also analyzed them.
These clinical trial databases were conducted between 2010 and 2018. The conclusion the Sexual Medicine journal reached pointed to the potential for shockwave therapy in treating and improving the symptoms of erectile dysfunction.
2021 Transitional Andrology and Urology Analysis
This analysis was conducted to determine whether or not there is a place for shockwave therapy in the treatment of erectile dysfunction. What the analysis determined is that some studies show that shockwave therapy improves erectile dysfunction in those who have mild symptoms.
The study also showed that Shockwave therapy is shown to work only in patients with moderate or extensive symptoms. The key information to take away here is that shockwave therapy is provably effective. How it works for mild, moderate, and severe symptoms is dependent on the device and how the study was conducted.
2016 National Library of Medicine
This 12-month study was aimed at the direct effects, whether positive or negative, of low-intensity shockwave therapy on patients suffering from ED. The patients involved in this study were patients who lacked a positive response when taking phosphodiesterase type 5 inhibitors.
Only 80% of the subjects completed the entire study but 60% of those who did showed an improvement. 48% of the “intent-to-treat” patients also showed positive improvements.
Are There Risks and Side Effects?
One of the best things about shockwave therapy is the lack of risks and side effects to this point. That’s not to say there won’t ever be any side effects. But, the studies conducted with a focus on erectile dysfunction issues are not returning side effects and risks.
That’s the kind of information that will bolster a future FDA approval. Of course, none of that is to say that you shouldn’t talk to your doctor about it. Any time there’s even the remotest concern for health risks or side effects, you should consult with your doctor.
As most experts are willing to point out, shockwave therapy is still in its infancy, especially where erectile dysfunction is concerned. There is still the possibility that some risks or side effects will crop up in the future.
Who Performs GAINSwave Therapy Procedures?
Getting shockwave treatment for erectile dysfunction is not like going to a chiropractor, a hypnotherapist, or an acupuncture doctor. Some of those practices have effective treatments but not much in the way of FDA-approved treatments.
With GAINSwave, on the other hand, a licensed urologist will more than likely treat you with shockwave therapy for ED. Since it lacks FDA approval thus far, some doctors will refrain from using it.
However, you’ll find that shockwave technology is more prevalent than you think. The fact that urologists are known for administering the procedure is even more evidence that shockwave therapy is very helpful for a wide variety of patients dealing with erectile dysfunction.
That doesn’t mean your urologist won’t recommend other things as well. It may be that you’ll be prescribed additional medication for a one-two punch. It may also be that your doctor will recommend dietary or other lifestyle changes to go along with the shockwave therapy.
Counseling is one of the things you will find is the most prevalent secondary treatment that goes hand-in-hand with shockwave therapy. This is mostly because your mental state plays a huge role in erectile dysfunction.
Some men who deal with ED have nothing wrong with their penile tissue whatsoever. Their problem is entirely a mental block. So, it’s not uncommon for therapy sessions to be prescribed along with continuing GAINSwave treatments.
Is GAINSwave Shockwave Therapy Painful?
You’ll find that most studies don’t point to anything that indicates a painful side effect during or after shockwave therapy. That doesn’t mean there won’t be any pain. Most patients report that the treatment is entirely painless.
As with the overall short-term and long-term efficacy of GAINSwave treatments, along with the potential for side effects, pain is something that still requires more studies and information to determine. On the positive side, it’s not something reported in association with GAINSwave treatments.
Why is GAINSwave a Better Option Than ED Pills?
The number one side effect when taking Viagra or Cialis is headaches. Since both medications work to promote blood flow and dilatec blood vessels, it’s logical that headaches would be the natural follow-up once everything slows back down.
They’re also costly, though the release of generic versions has helped to drive down costs over the last few years. Even if you opt for the generic versions, it usually comes with a large, upfront expense or a costly subscription service.
Then there’s the fact that pills don’t always work. Men still have to be aroused, even when the pill is in full effect. If he’s suffering from a migraine from taking the blue pill, he’s less likely to get aroused when the time comes.
GAINSwave shows a lot of promise and there’s a reason that a lot of men who deal with ED are looking to shockwave therapy for results they can’t get from taking the blue pill.
All Things Considered
Though many are concerned about a lack of FDA approval when it comes to GAINSwave therapy, the studies, and clinical trials are growing in number. They’re also showing that there is a lot of promise in the efficacy of shockwave therapy, especially for long-term purposes.
In general, you can only get these treatments from a licensed urologist and that shows acceptance among doctors. The biggest hurdle with ED is getting men to talk about it. You will never find out if GAINSwave works for you if you never talk to your doctor and see if it’s the right step.
de Oliveira, P. S., & Ziegelmann, M. J. (2021). Low-intensity shock wave therapy for the treatment of vasculogenic erectile dysfunction: a narrative review of technical considerations and treatment outcomes. Translational andrology and urology, 10(6), 2617–2628.
Bechara, A., Casabé, A., De Bonis, W., & Ciciclia, P. G. (2016). Twelve-Month Efficacy and Safety of Low-Intensity Shockwave Therapy for Erectile Dysfunction in Patients Who Do Not Respond to Phosphodiesterase Type 5 Inhibitors. Sexual medicine, 4(4), e225–e232.