Episode 13 – Incorporating shockwave treatment for ED. A clinic owners perspective in Canada
Our guest this week is Drew Klein, owner of a specialist Shockwave Clinic in Ottawa Canada – https://focuswaveclinic.com. He works alongside Hugo Aguirre, a Vascular Surgeon in delivering Focused Shockwave to patients with Erectile Dysfunction (ED), Peyronies and Chronic Pelvic Pain.
Given the rapidly growing interest in ED treatments I thought it useful to get a perspective from someone who has developed and delivered a shockwave specific clinic.
Drew isn’t clinically trained but has over 20 year’s experience in finance and technology which provides him with an ideal skill set to build a successful clinic/brand.
We discuss all things ED and Peyronies as well as our views on focused vs radial SW in ED treatment.
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Podcast Transcript
James Woledge
Welcome to The Shockwave Therapy Podcast. My name is James Woledge, osteopath and clinical director of the Abbeyfields Clinic in Suffolk. We will be trying to demystify the concept of shockwave treatment, whilst bringing together experts in their field to discuss the latest research. If you are deciding on whether to add this modality into your clinic, or just improve the way you deliver it, then we hope this is the podcast for you.
Today, we are talking to Drew Klein, president of focuswaveclinic.com, which is a specialist shockwave clinic in Ottawa in Canada. He works alongside a vascular surgeon in treating erectile dysfunction, other men’s health issues, and chronic pain. Really, really excited to talk through his ideas on the use of shockwave in these conditions, particularly as he, as opposed to lots of other guests on this podcast, just uses shockwave, and it’s a specialist clinic just for that.
He’s got an excellent website, which is worth looking at if you’re interested in using shockwave for erectile dysfunction, Peyronie’s disease, and so forth. It’s really nicely laid out and very clear to people looking at the website what they can deliver. Really looking forward to understanding how he’s developed his protocols, and indeed, the business side of delivering shockwave in this arena. Thanks for joining me, Drew. I’m really happy that you’re on here because I get some nice emails off of North Americans, as I have to group you together with the US of A, saying that they listen to my podcast and that’s nice.
The other reason it struck me as being opportunistic, is the subject of erectile dysfunction and men’s health just keeps coming up. I’ve done a few podcasts recently on this. And when you got in contact, and I saw the makeup of your website, it struck me as fairly, it was a lovely website and your backdrop is nice, obviously, as I just said. But over here in Europe, there is a tendency to see shockwave as an adjunct. You’ll see a physio clinic, or a normal andrology clinic, or an endocrine clinic in London, where they use shockwave as a part of what they do.
But I quite like the bravery of what you’ve done. You’ve really gone out, and set your stool, and said this is pretty much everything focused around the shockwave and what it can bring to bear on erectile dysfunction and chronic pain. That’s why I was looking forward to this evening because I’ve never seen that. That’s pretty unusual. Can you just give us a background on how you set up, and what your position is in the company, and where you’re at?
Drew Klein
I’m the president and clinical director of FocusWave Clinic. We did start off the clinic with the intention of focusing strictly on shockwave therapy, focused shockwave therapy for men’s sexual health. We do at some point, see some branching off potentially happening. But for now, we have remained focused on this very specific modality and treating these very specific conditions. I’m not a doctor. I went to school to be a doctor. I was a biology major at the University of Waterloo.
I realised in my fourth year that I couldn’t do it. Wasn’t toiling away in a lab, or being a doctor, or being a surgeon was not for me. It’s just not something I could do. I did 10 years in high finance, living in Los Angeles. I did 10 years in high-tech here in Ottawa. When the stupid COVID hit, I realised that this was as good an impetus as any for a career change. It seems like my attention span is only about 10 years. I met Hugo, who’s our MD here at FocusWave, through a friend of a friend.
He’s a vascular surgeon from Ecuador, a Canadian, international, medical graduate. And in my opinion, there was nobody better to discuss sexual health conditions, specifically erectile dysfunction or shockwave therapy, which promotes the neovascularization of the treatment area. There’s nobody better to discuss this type of treatment with them than with a vascular surgeon. I was very attracted to the idea of working with Hugo and because we know ED is mostly vasculogenic in nature.
Hugo’s a kindly, gentle, refined, old gentleman, 67-year-old doctors how they should be. He smells good too. That’s a plus. He described to me his experience with shockwave therapy. He was using radial acoustic wave, shockwaves on patients and having limited success. He described the focused or the linear shockwave therapy devices, which are a much more powerful version of shockwave therapy, and how this device can successfully treat all these different sexual conditions, ED, PD, chronic pelvic pain syndrome.
And more importantly, treating them with no pain, no side effects, no pills, and no surgery. I had been in high-tech for the last 10 years. I was blown away by the technology and what it had the potential to do. We started up this clinic, got it all set up, and we launched October 2020 in the midst of a pandemic, in the midst of a lockdown here in Ontario, Canada. We’ve been off and running ever since.
James Woledge
Well, that’s a great story. When you met him separate to the idea of shockwave, it was a chance happening? Or did you purposely go out to meet someone that was already in the field and say, “Do you want to set this up? We should use focused, or whatever.”
Drew Klein
It was through a friend of a friend, somebody who we all went to the same gym together, actually.
James Woledge
Right, okay.
Drew Klein
It was a friend of a friend. Always interested in my background in science always has kept me interested in this field. And then once this stupid COVID struck, I figured this was my way back into the healthcare biomedical field.
James Woledge
Between you two, you did some research and then discovered that, because we have this over here. I think over there, without mentioning names, the major marketplace is acoustic or radial wave for ED in North America. Over here, it actually is via the research. It is focused based, but we see that there are more and more clinics trying the radial approach. I get questions about this all the time. The vast majority of the research, by a significant margin, is with focused. You must have discovered that yourself.
Had you over there because you’re up against, I’d rather not name names, but there’s a major company that are absolutely huge in North America, and they promote radial, albeit the research is not there.
Drew Klein
Right.
James Woledge
The technology is a lot more expensive, but you must’ve done the research and reading and said, “This is the way we want to go.”
Drew Klein
Yeah, I mean, with Hugo’s experience in treating people with ED using a radial device, realising it’s a painful procedure. Realising that there are side effects, and numbing creams, and downtime, and then realising that there was a much more advanced device that you could use, that was also approved by the National Regulator here. And that also was covered in all of those peer-reviewed studies. As you know, most of the peer-reviewed studies that show success for using shockwave therapy for these sexual health conditions are using focus devices.
We found a lot of these clinics… And as you know, radial and acoustic devices are very useful. They’re very helpful for certain orthopaedic pain conditions. They have their use in the medical field. But when it comes to treating the very sensitive penis and crural area, and treating ED, and PD, and CPPS, you need something that can achieve the depths required. What I always compare, because we get a lot of people who come to clinics in Ottawa and around the area.
Also, what you’re talking about is GAINSWave. I don’t know if that’s a pejorative or something, but using radial as a tool for treating ED, apparently they have some success, but from my understanding is it’s painful. It requires numbing creams for many men. It just can’t achieve the depth required that you need to treat ED and PD to clear scar tissue, and break up plaques, and to create the neovascularization. I always compare it to, when I’m talking to a potential patient, I say, “You can go to a clinic that offers radial, or acoustic wave, or whatever wave they want to say.”
“But that’s like a bicycle compared to a fighter jet, when you compare it to a focused wave device, or a focused shockwave device.” The focused shockwave device is supremely more powerful. It’s electromagnetic, it’s not pneumatic, and noisy, and painful. It’s the next generation, the most advanced technology possible in this modality.
James Woledge
And could I ask what you use? Do you use a Stuarts device?
Drew Klein
Yeah, we use the Stuarts SD one.
James Woledge
Okay. But you don’t have the radial with it, or does that come with the radial?
Drew Klein
No, you can buy the radial. We’ve looked at it because you could also use it to treat… We use the focused as well to treat some chronic pain conditions.
James Woledge
Yes, I saw that on the website.
Drew Klein
It’s not a majority of our business because, as I’m sure it is in the UK and many places, very, very competitive, in terms of the physio and the chiro markets. While we do seek referrals from those people for this highly advanced treatment, it’s not something that we really advertise or push hard.
James Woledge
Okay. I guess you have the advantage of the doctor working with you in this country. In the UK, we can’t prescribe or anything else. We can only suggest, and we try to liaise as closely as we can with the patient’s doctor on this subject. Do you use a combined approach? Does he also prescribe any of the medications, Viagra and so forth, alongside the treatment? Or do people tend to see you because they don’t want to take the treatment, the medications, and they see this as an option on the side?
Drew Klein
Yeah. We’re a private clinic, so we do not. Hugo is an international medical graduate, which means that he’s not a Canadian College of Physicians doctor. He’s well-trained in shockwave, but we aren’t able to prescribe these pills, the PDE5 inhibitors. What we usually see is if it works for the patient, that’s great. As you know, for some people, the PDE5s don’t work anymore, or they don’t work very well, or they just want to avoid taking pills altogether.
The patient certainly has that option. It’s usually up to the discretion between him and our clinician, as to what’s the best way going forward, as far as adjunct treatments, additional things. Whether going to see a naturopath, or going to see a dietician, which as you know, those are all very important things to look at as well when you’re considering taking your sexual health back.
James Woledge
Okay. Because this is still relatively new, relatively novel, although it’s been probably around for several years. There’s still some debate as to how many sessions, the space between sessions, and so on, and so forth. From your experience, what sort of protocol do you use? For example, do you do blocks of five sessions? Do you assess them first to see whether they’re severe using various questionnaires to sort of sus whether they’re going to need 10 sessions? How does your process work when you see those patients first?
Drew Klein
I’m always very interested in the practice of medicine because it really is a practice. There is nothing that is truly set in stone here. We need to get better and improve at the technique that we provide. The literature, in most cases as you know, and the peer-reviewed studies, they tend to do six treatments, as a standard course, twice a week for three weeks, seems to be the standard. We dusted around on a few different strategies there. Sometimes offering eight treatments, sometimes offering four treatments in a row, or three treatments in a row, twice a week.
Or twice a week, or three times a week, twice a week. We found that the best success we’ve seen so far in your average patient, has been doing six treatments twice a week for three consecutive weeks. Trying to do it at the same time for the patients so they feel like it’s part of their routine schedule for the next three weeks. That’s for erectile dysfunction, for mild to moderate erectile dysfunction. For severe cases, we generally are suggesting 12. Six followed by a two-week break, and then another six. But it does depend on the patient and the severity of their condition. As you know, some guys come in and they-
James Woledge
Sorry. You have a six-week break between the two sixes?
Drew Klein
No, a two-week break, two-week break.
James Woledge
Two-week break. And why do you have that?
Drew Klein
We’ve also discovered over the last seven months that we’ve been treating patients, that during the healing period that follows the six treatments, that there’re gains that can be seen, in terms of SHIM score performance. We give everybody a SHIM score when they first come in, when they complete the treatment at 45 days and at 90 days as well. And we’ve noticed that during this healing period where the body is continuing the process of angiogenesis and neovascularization continues.
And the blood flow tends to improve, and the performance tends to improve during this healing period. It is, I guess, I don’t want to say destructive. It is a very serious medical process that does take time to heal. Your body does need that time, so we give them a two-week break in between those two, six, six treatment courses.
James Woledge
And can you just explain to everyone what a SHIM score is.
Drew Klein
Sexual health inventory in men is just a basic five question, questionnaire that determines the severity of your erectile dysfunction. It’s ranked on based on one being the lowest score. And 25 being the highest score, you’re basically a porn star, or how you were and most people when they were 18. And one being somebody who is not having sex, avoiding sex, can’t perform sex.
James Woledge
Okay, fine. All right. I’m assuming you’re getting good results with this. When patients come to see you and they say, because they do, and it’s going to be reasonably expensive. What are your success rates and so forth? What sort of things do you say to patients? Let’s say you’re mild to moderate, what sort of chances of success are you saying to patients from your experience in the clinic?
Drew Klein
Again, we always revert back to the peer-reviewed studies, which show about a 70% success rate for patients lasting anywhere from 18 months to five years. That’s what the realistic numbers show. What I try to iterate to our patients is, first and foremost, it doesn’t work for a hundred percent of people. That’s a given, nothing does. I believe we’re seeing in our clinic even better numbers than the 70%, closer to 80, 85%, and there’s a reason for that.
I think it’s because we don’t have to be as rigid as the studies tend to be. They tend to be very, very structured.
James Woledge
They have to be.
Drew Klein
To be a good study it would have to be, and we don’t have to be. We increase the number of treatments. In some cases, we offer a few additional treatments. If the patient’s not quite seeing what they wanted to see, we target different areas in the body, different areas on the penis and the crural area. We increase the frequency of the shocks. We can increase the number of shocks. We can increase the energy level of the shocks. Again, that’s the beauty of these focused devices is that you really have this flexibility.
It does depend on the patient’s condition, but we try to make sure that our patients understand that this is not a magic bullet. There is no panacea. Some of our patients have been dealing with sexual health conditions for years and years. And as men, first of all, we don’t like to seek medical treatment. It’s not in our nature to admit that we have a problem. That’s why there’s the gender health paradox and that’s always an interesting discussion. But for the most part, men want to see results immediately.
I know I do, and it’s not necessarily a realistic idea of how this actually is supposed to progress. The success rate that we’re seeing right now is unbelievable. It frustrates me to see patients who don’t see success. But what we try to do, is we to push them after 12 treatments, generally speaking, if it’s not working for you, it’s not going to work. That’s what we believe. And we don’t want our patients to just go away and say, “Well, that was a waste of six weeks, and that was a waste of several thousand dollars.”
We try to encourage them, and push them to make other lifestyle changes and make other improvements in their life. That be a diet, exercise, sleep, intellectual stimulation, whatever it might be. We try to push them into these other avenues, which they should be doing in concert with this treatment as well.
James Woledge
I don’t profess to know anything about the general health care system in Canada, but what’s the general acceptance level amongst mainstream medicine in your country for this type of treatment? Is it still extremely new, and no one knows about it, and doctors are being very cynical about it? Or are you starting to get a sense that there’s now, yes, that’s an alternative, if you don’t want to take medication. There’s a clinic down the road that does this. We’re still struggling with that slowness over here, I have to say.
Drew Klein
I think it’s very anecdotal. I mean, many doctors, even one of my best friends is a urologist. They had an old shockwave therapy device in their clinic. They pretty much gave up on it. I don’t think they used it right, or they didn’t really spend much time on it, so they kind of just dismissed it as not really being an effective tool. When I showed him the results, he’s totally blown away. I think doctors know what they know. A hundred percent of them know to prescribe PDE5 inhibitors. That’s just easy, write a script, and here you go. This will treat the symptom. For the most part, doctors, or mainstream doctors, aren’t very interested in focusing on treating the cause.
In this case, with focused shockwave therapy work, we’re going after the root cause of the problem, rather than just treating the symptom. Again, like I said, I’m not a doctor. I have tremendous respect for anybody who’s gone through the process of becoming a doctor. We try our very, very best to put this technology in front of all the doctors in our city and wherever we plan to expand to, to show them that this is a non-invasive, safe, effective procedure for treating sexual health conditions.
James Woledge
Yeah. Good for you. I mean, we certainly have, as I said at the start of this, I think we’re seeing this big, much more prevalent, in terms of the noise around shockwave. And because I have a podcast, and I teach along with some colleagues, we’re getting it asked of us much more now. Because it used to be, I’ve been involved in it eight years, and it was all about achilles tendons and plantar fasciitis. Now it’s much more the conversation, what does it do with ED? And indeed, with some doctor friends of mine they are aware of it as well.
Drew Klein
I think our medical systems, like in Canada and the US, have a lot of similarities as a very large, public component to our healthcare. It’s free, like it is with the NHS in the UK. Private healthcare like this because we’re a private clinic and we don’t accept any forms of insurance or anything like that.
James Woledge
Does insurance get involved with this treatment at all? They’re not there with that?
Drew Klein
No. The OHIP, which is our healthcare here in Ontario and the province of Ontario, they do not cover it. Extended benefits from third party insurance companies also do not cover this. It’s a straight out of pocket situation. You’ve been in this business longer than I have. Did you find that during the COVID you saw a significant decline in the number of patients looking to come? We’re dealing a lot, oftentimes, with people who aren’t at a hundred percent peak health. Some of them might be a little bit scared to venture out or to do things. Did you find a decline in business or was it flat, or did it rise?
James Woledge
Initially, a huge decline for the first four or five months. But we actually, most of our clinics in the UK shut down for three months-ish. Although the legal nature of that was dubious, but I think we all felt like we needed to do our part, so we will all shut. And then when we started up in 2020, we were running about 50 to 60%, because I think confidence was very low. People didn’t want to come out, and come into clinics, and so forth.
But over the last, since the start of 2021, we’re back to normal, pretty much. Albeit where we have certain conditions that mean that we can’t see as many patients, but we’re okay. I’m not moaning. There have been plenty of people worse off than us, so I still have my business and it’s okay.
Drew Klein
Are there special regulations, in terms of how the Stuarts, the SD one is classed in the UK versus?
James Woledge
No. In the UK, as osteopaths or physiotherapists we’re allowed to use focused or radial shockwave equally. It literally is, can you afford it? The training’s a bit more specialized because I’m involved in some of that, on behalf of Stuarts, in particular. In Germany and a few European countries, there is a separation off between who is allowed radial and who is allowed focused, between doctors and physios, osteopaths, and so forth. There is a separation there, but not in the UK.
We’re lucky in that regard so I have a focused device. I have a radial device and I use both equally and both in combination. For most of my patients, is musculoskeletal. But my physiotherapist, alongside myself, he treats ED and Peyronie’s, which is the second thing I was going to ask you about. Your Peyronie’s because that’s still a bit of a topic of conversation between me and my colleagues that teach this, because we don’t see as many Peyronie’s disease, as we see erectile dysfunction because there’s less of it.
And there’s been a few cases anecdotally between us where its flat symptoms cause more pain. We’re still a little unsure. There’s nowhere near as much evidence and research for it as there is for ED. What’s your experience been? Have you seen some patients for this yet? And what does Hugo say about this?
Drew Klein
PD is obviously, maybe a fifth of the market, is about the fifth the size because they say it only affects about 10% of the male population. PD, Peyronie’s disease, being a curvature of the penis. What’s interesting about it is that the big thing that shockwave therapy does, as you know, is the neovascularization, the promotion of new blood vessel formation from the existing vasculature, which is very important in the process for erectile dysfunction. But the second most important thing that shockwaves do is the clearing of scar tissue and plaque.
That’s often characterized in Peyronie’s disease is having some scar tissue or plaque, either from an injury, or from something, some event that happened, that causes your penis to curve. The success rates we’ve seen in treating PD for certain symptoms is amazing. We’ve had great results for plaque reduction, for pain reduction, for improving erectile function, and for sexual satisfaction. The results on penile curvature improvement are somewhat mixed.
James Woledge
Yeah, we’re finding that.
Drew Klein
We make sure that our patients understand that, but there are studies that show using the SD one, that do show a statistically significant reduction in curvature. We’ve seen it in our clinic, and our patients have reported it. In our experience, improving curvature’s about a 50/50 bet at this point, I think, is somewhat safe to say in this early going point for us. We also noticed that a lot of patients who come in with PD have ED as well. We do a combination treatment of PD, ED treatment. We start all of our patients in a PD treatment course of five treatments, once a week for five consecutive weeks, followed by a two-week break.
And then we do a six-week, I’m sorry, a six treatment course for ED. We try to first clear out the scar tissue and the plaque, and then we do an ED treatment that follows.
James Woledge
That’s interesting and it sounds very sensible. We don’t do that over here. We just do as a mix. But that’s going to give me some thinking time, because that makes a whole lot of sense.
Drew Klein
I think it has to do with when you treat both at the same time, your session becomes twice as long. You may need to do 3,000 to 4,000 shocks for each treatment. You start to look at the 45 minute treatment, rather than the 22 and a half minute treatment that we’re accustomed to.
James Woledge
Yeah. I think that with actually some of the flares that have taken place anecdotally, it would make sense not to overdo it in one session, rather than what you’ve suggested. To spread it with a gap between actually is really good. I’m going to think about that this evening.
Drew Klein
It’s all practice.
James Woledge
Yeah, it is.
Drew Klein
I see it.
James Woledge
It’s novel, it’s new, it’s exciting, but we’re still finding a way. But this is where hopefully, conversations like this help everyone because you’re doing it, we’re doing it. We’re finding, still at the moment, what is the best balance to do with that condition? You say so many of the patients we see are overlapped between Peyronie’s and ED. Now I know more about that condition, I’m not surprised. If I had that to live with, I’m sure I would have ED as well for all sorts of reasons, psychological as well.
That’s interesting. When you do say to the patients when they come in, you’re fixing their expectations, are you, on reducing pain, and increasing performance, rather than curvature, which might be almost a lucky after effect that 50/50 you’re talking about.
Drew Klein
Yeah. We certainly try to improve it. Again, it’s one of those things where you’re not going to come in and do one or two treatments and say, “Look, it’s working, it’s fixed.” It’s a longer-term process. There are additional adjuncts that you can use. A lot of guys have been recommended traction devices for PD, which from what I understand, is quite painful, also some injections.
James Woledge
Do you suggest any pump work alongside that with ED?
Drew Klein
No, we haven’t ventured into that side of the treatment protocol. Again, as you mentioned at the beginning, I’m just super focused on providing this one specific treatment. It’s a tough one because the alternative is to go for needles, injections, which also don’t have a hundred percent chance for working either. And now you’re causing significant distress to your penis. There’s not many people I talk to who say, “Yeah, I would definitely do injections and needles.” Most of them are trying to avoid sticking themselves.
James Woledge
Yeah. Well, actually the prevalence of the P-Shot, as it’s called, seems to be growing, but that’s a one-off hit. I hope the PRP is thought to generate some new vasculature as well and create healing response. I think I always say to patients, no matter what the condition they’re coming with, why wouldn’t you want to try something noninvasive before you try something invasive? I know that I would.
Drew Klein
Especially now with COVID, and the risk of infection, and you’re doing things like that. To me, it’s a no-brainer. I don’t like going to the dentist because I find that painful. So if I’m dealing with my sexual health and I’m struggling with erections, and struggling with my confidence, and all of those things come in, you want to go and you want to work with a clinic that’s going to provide you with a non-pharmacological treatment protocol that doesn’t hurt. That allows you to leave the clinic and go have sex with your partner immediately.
I mean, that’s what’s so cool about this treatment is that I have such great stories from our patients. I have unbelievable anecdotes and they are anecdotes, they are. But when you have an 80-year-old patient who hasn’t had an erection in eight years, and after one treatment, he comes in and he says to you, “Drew, I had a nocturnal emission last night.” That’s enough for me to say, “Okay, I made the right decision to do this.” This is working for this guy. It couldn’t make me happier to see this success story.
James Woledge
Yeah. I think I’m going to call it a wrap because I think that’s a nice point to stop, talking about nocturnal emissions. What a lovely way of saying it. I’m going to go away and think about your five and six combination for Peyronie’s ED combination. That’s nice. I’m going to stick that on my group for the people that I teach with on that this evening. Thanks for stimulating my brain. In that regard, thanks for coming on. It’s been super duper, so hopefully we’ll get more listeners in North America listening to the podcast.
Drew Klein
Absolutely. Thanks for having me in. I certainly look to share more information in the future and help more men.
James Woledge
We can only get better if we share in this stuff. Thanks, Drew. I’m going to say goodbye.
Drew Klein
Cheers.