have you ever heard of Shockwave therapy for erectile dysfunction well I'm Dr Reena Malik urologist and pelvic surgeon and today I'm going to talk all about what we know up until 2023 about Shockwave therapy for erectile dysfunction so there is new data emerging all the time about Shockwave therapy I made a prior video and so this is an update on kind of where the data is today to start off we're going to talk about what shock waves are shock waves are essentially sound waves that can carry energy propagate through a medium which is usually gel and transfer to tissue now shock waves have different kind of waves the specific type of wave that you see in low intensity shock wave therapy which is the one that is highly studied for artile dysfunction has a very characteristic waveform it has a high peak pressure which is achieved very rapidly and then there's a subsequent pressure Decay and these particular shock waves have three parts of them first there is a short pulse followed by a rapid increase to maximum positive pressure followed by a prolonged period of negative pressure there are three types of Shockwave generators electrohydraulic electromagnetic and piso electric and each of these uses a different method to generate the shock waves the electrohydraulic lithotriptor has two electrodes where there's high voltage applied and there's a spark that's generate in between them this causes a high amplitude wave that's in a spherical shape that's then focused by a reflector on the other hand electromagnetic waves use a high voltage electric pulse that causes this metal membrane to move away from a coil this causes the pulse itself and then the shock wave is focused by an acoustic lens or reflector and lastly the piso electric lithotriptor uses special crystals they're shaped like a sphere that rapidly expand when you apply an electrical pulse this then creates a pressure wave and the spherical shape of the crystals then causes the focused shock wave so a lot of you ask me what are the names of these lithotriptors and how do I know that the one that the person who's discussing shock wave with me is actually the right one there are three electromagnetic machines available one is called duolith sd1 made by stores medical another one is called Aries made by dorier Medtech and the last one is called Renova made by the Dux system for piso electric there's only one option it's the piso Wave 2 well you may have heard of some other companies some other brands some other machines that people are using and what exactly are these well a lot of them use radial shock waves so how do radial shock waves differ from these focused shock waves that you're getting from low intensity shock wave therapy the radial shock waves are actually pressure waves that have maximum pressures that are 100 times lower as well as pulse durations that are 100 times longer which means that they have a shorter and longer pulse wave rather than a very focused and more intense shock wave therefore they tend to penetrate the tissue at a much shallower depth of penetration which is is usually about Less Than 3 cm compared to the low intensity shock wave therapy which is penetrating about 10 to 12 CM because of these different types of shock waves radial shock wave therapy is classified as an FDA class one device meaning that it does not require any medical supervision however the low intensity shock wve therapy is a Class 2 medical device and this actually requires supervision by a medical professional and because of this radial shock waves are very commonly used because there's no require reement for medical supervision also there's been very little peer-reviewed published literature on the efficacy of radial shock waves there are some small studies that say they work effectively however the majority of the data that we're looking at is in this low intensity shock wave space I would encourage you if you are looking to get Shockwave treatment to look for one of those machines that I mentioned earlier so how do shock waves work well they create damage in one of two ways the first way is directly they create mechanical stress on the tissues because of that high int it shock and two indirectly because they create a sort of turbulent flow in the blood vessels this turbulent flow causes the body to react and respond to it like there's some trauma going on this causes the body to increase the amount of growth factors specifically vegf or vascular endothelial growth factor which causes more blood vessels to be grown a term called angiogenesis it also causes recruitment of what we call stem cells or other early types of cells which then differentiate to create more blood vessels and repair damage tissues that cause erectile dysfunction it may also increase the production of nitric oxide in those tissues and if you're new here nitric oxide is the ignition for erections if you don't have sufficient nitric oxide you can't have an erection there's also some animal studies that show it may play a role in nerve regeneration because it clears up some debris and scarring in the nerves and also recruits cells like Swan cells which are important in nerve regrowth so what do we know about Shockwave therapy well we know that there have been several randomized control trials meaning that they had patients have shockwave therapy and another group not have shock wve therapy and then they compared their outcomes they've done it with no treatment versus a sham treatment they got something that sounded like a shock wave but it really wasn't a shock wave and they've also done metaanalyses and systematic reviews looking at the outcomes of all of these studies together and when reviewing all of the literature on shock wve therap we found that men who have vascular genic ed meaning having erectile dysfunction because they have poor blood flow to the penis like high blood pressure from smoking other things like that particularly those who are still responsive to medical treatment me they still get an erection when taking something like selenop or tadalfil or brand named Calis or Viagra and they're still able to get an erection with medication however also in patients who have moderate erectile dysfunction it seems to be mean they may have just recently stopped responding to oral medication or they still occasionally respond to oral medications so when we look at the data when you compare Shockwave to Sham therapy we found pretty much solid evidence that it does improve erectile function based on the erectile hardness score which is a fourpoint score which people can use to kind of explain how hard their erection gets zero meaning they get no erection at all and four meaning that they're completely firm and rigid and they've even looked at something called the Peak systolic velocity on ultrasound of the penis what that means is that the speed of the blood flowing through the arteries to the penis increases after shock wve therapy the other important thing is that in these studies they've shown no obvious side effects associated with treatment so when I last made a video about Shockwave therapy I told you guys that we had oneyear data meaning that Shockwave after one year showed that about 50% of people with mild to moderate erectile dysfunction had stained improvements in erectile function at that time point so now we have some small numbers of patients at 2 years and 5 years in this study they followed about 156 patients who had erectile dysfunction of those patients in the initial study at 1 month they saw 64% have success meaning that they achieved a clinically meaningful difference in their erectile function after receiving shock wave therapy however at 2 years postoperatively of those remaining 64% only 53% continued to have an improvement in erectile function that's only 34% of the entire cohort interestingly when they broke these patients down and they took out the patients who had diabetes and severe erectile dysfunction 0% of those saw any Improvement at 2 years however when they took out those patients 76% of the remaining patients did have a successful outcome at 2 years another study at 5 years only followed up about 30 patients over those 5 years they found that erectile function continued to deteriorate but tended to Plateau at about 40% meaning that 40% of patients had some clinical efficacy at 48 to 60 months after completion of the shock wave therapy the other important thing was that there was no penl pain or deformity in these patients at 5 years meaning that it is safe also there's been a few small studies looking at shock wve therapy for patients who've had nerve injuries specifically during radical prostatectomy for prostate cancer or radical cystectomy for bladder cancer and the numbers of patients have ranged anywhere from 19 to 128 patients and in many of these studies they've seen some improvements however it's not met the definition for clinically significant meaning you see a little bit of improvement but it may not mean that much to you as a patient and so the thought is that in these patients shock wve therapy may be beneficial as an adjunctive treatment meaning you can take it with medication or with other treatments to obtain better erectile function so taking all this together together Shockwave therapy seems to be most beneficial for patients who have mild to moderate erectile dysfunction ideally not diabetic it may be best for patients who want to optimize their response to medications or for those whove recently lost response to medication and need something additional to help with erectile function and again I think the big important take-home from all this is that there has been no significant short or long-term side effects associated with the treatment so why are people not recommending ing this as a treatment why is Insurance not covering it well at this point in time very few associations around the country and around the world actually advocate for the use of shock wve therapy for example in metaanalyses of these studies when you look at a number of these studies you can find that the duration of treatment and the number of shocks per session and the machines used are very very different for example when looking at 14 studies they found that shocks per session range between 1,500 shocks to 5,000 shocks and that the length of treatment varied anywhere from 6 weeks to 9 weeks so it's hard to compare the results of these studies to each other also there has been no significant long-term data and we still don't know is there a value in adding a maintenance maybe after a year should you get another round of shock wve therapy and how long should that be does it need to be another six weeks does it need to be 3 weeks does it need to be a week we don't know another issue is that many of these studies were not powered appropriately meaning that in order to see a difference from Placebo or from a sham trial you will expect that Placebo effects are high in that arm just like we've talked about before on this channel placebo effect is very powerful in most erectile dysfunction trials Placebo effects are about 25% so you need to power a study appropriately so you can accommodate for that placebo effect and say okay I know that placebo effect is going to be this much I also know that I need to get this significant change between the placebo group and the clinical trial group to see that there is an actual difference and that that difference is Meaningful that's not just statistics and so if the studies are not powered appropriately you have to take those studies results with a grain of salt and lastly a lot of the studies have included multiple patient populations or have not focused in on the specific degree of severity of the erectile dysfunction to identify which patient populations this is going to be best for so where does this treatment actually fit in is it in patients who are just starting to get erectile dysfunction is it patients who have failed medical therapy who is it best for and where are we going to put it in in the guidelines so the sexual medicine Society of North America has created a position statement about these treatments and they say quote the emergence of restorative therapies such as low intensity shock wve therapy stem cell therapies and platelet rich plasma therapy represents a new frontier of investigative therapies for erectile dysfunction at the moment however the cumulative body of clinical trials for restorative therapies is large ly incomplete and many questions remain unanswered the society however recognizes the need for adequately powered multi-center randomized sham Placebo controlled trials in well-characterized patient populations to ensure that efficacy and safety are demonstrated for any novel Ed therapy the society agrees with the regulatory agency pathway of approval including safety and efficacy studies to achieve goals in diverse patient populations without FDA approval the use of any novel therapy is considered off label to date there is an absence of robust clinical trial data supporting restorative therapies efficacy in humans although relative safety has been established for stem cell therapy and low intensity shock wave therapy furthermore the precise treatment parameters for low intensity shock wve therapy such as energy settings dosing frequency of use and duration of therapy among others remains to be fully elucidated so bottom line I think that shock with therapy is really exciting and has a place in the treatment for erectile dysfunction however because it's not yet covered by Insurance it can be very financially costly and if you don't do your research you may end up spending a lot of money and you may not benefit from the therapy so it's important to know if you're going to investigate into shock wof therapy that you know which type of generator is being used and if you are a candidate for this treatment do you have mild to moderate vasculogenic erectile dysfunction because if you don't at this point we don't know if it's going to help you of course many studies are underway and hopefully we will have answers soon as always I hope you guys enjoyed this video if you did please share this Channel with your friends and as always remember to take care of yourself because you're worth it [Music]