Buyer Beware: Quick Fixes/Clinics for Low Testosterone and Erectile Dysfunction

Podcast Transcript

Dr. Scott Steele: Butts and Guts, a Cleveland Clinic podcast exploring your digestive and surgical health from end to end.

Dr. Scott Steele: Hi again everyone, and welcome to another episode of Butts and Guts. I'm your host, Scott Steele, the Chair of Colorectal Surgery here at the Cleveland Clinic in beautiful Cleveland, Ohio. It's always my pleasure to welcome back former guests. Today we are welcoming back, Dr. Petar Bajic, having a second time here on Butts and Guts, who is a urologist and men's health expert in Cleveland Clinic's Department of Urology. Petar, welcome to Butts and Guts.

Dr. Petar Bajic: Thanks so much for having me back.

Dr. Scott Steele: Fantastic. And so, today we're going to talk a little bit about direct-to-consumer men's healthcare, something you see all the time. We've had a couple of small tidbits on this, but I'm super excited to delve into the details. But, for those who didn't hear your first time on Butts and Guts, give us a little bit about your background.

Dr. Petar Bajic: Sure. So, I grew up here in Cleveland and did my undergrad at Case and then med school at Toledo, did a urology residency at Loyola University in Chicago, followed by a one-year fellowship in andrology and male genital reconstruction. So, in my practice here, I focus on men's sexual and urinary health. As part of that, I see men with a wide variety of issues. I also see a lot of prostate cancer survivors for their sexual and urinary concerns.

Dr. Scott Steele: Fantastic. And so, today we're going to be talking about the rise in direct-to-consumer men's healthcare. From standalone clinics to online platforms that are gaining popularity amongst men for treatment, it seems like you can't really turn on a television and not see something along the lines of erectile dysfunction. We're also going to be talking a little bit about why some men may be seeking this type of quick fix instead of talking to their urologist about the concerns they have.

So, to start, can you give us a little bit of an overview and explain what these men's health clinics and online platforms offer to patients and why you think they have become increasingly popular over the years?

Dr. Petar Bajic: Absolutely. So, these clinics have been around for quite a while. Their offerings have evolved over time. But essentially, what these are privately owned, for-profit clinics that do not take insurance and focus on treatment of things like erectile dysfunction, low testosterone. Many of them are focused on restoring youth and things like that.

So, what we see advertised here in town most is a lot of these wave therapies as treatments for erectile dysfunction. We could talk a little bit more about that, as well. That's the in-person type of care. There's also a slew of online digital health platforms which have become increasingly popular over time. Those include things like Hims and Roman, many of which offer convenient online prescriptions, usually at a pretty reasonable cost, but without having to necessarily come into a doctor's office. They take advantage of something called asynchronous telehealth, which essentially means you enter your information into a form along with a photo ID, picture to prove it's you, and then a provider reviews that and basically mails you a prescription.

So, this has been a booming industry in the digital health space. Many of these started as small popups in people's garages, which have now blossomed into multi-billion-dollar businesses that serve patients in all 50 states.

So, it's definitely an interesting area. I think that there are certain things about men, I think, that lure them to these things. Guys aren't crazy, in general, about talking to a doctor about things like cardiovascular disease. It's well-published that they're not necessarily as good about preventative health. Certainly, these issues can be associated with some stigma or perhaps shame for some people, and maybe they don't want to have to have that kind of conversation in person, or maybe not with their primary care doctor who they have established a relationship with. So, there's a little bit more anonymity with some of these services. There's a little bit more perhaps convenience, and men seem to be willing to pay pretty large amounts of money out-of-pocket for these services. I think that's been part of why these businesses have been so successful.

Dr. Scott Steele: Yeah. So, let's dig in a little bit deeper. There's no question, maybe even the private convenience, but you may not even want to sit in a particular waiting room and be looked at and have a little bit of awkwardness or even shame, if you will. And so, I guess my question to start off, is it safe for patients to go ahead, and that form that you're talking about, fill it out and rely on a digital diagnosis and treatment plans for things like erectile dysfunction? And are there risks or drawbacks even associated with some of these medications that are prescribed that can't be picked up through the use of this online platform?

Dr. Petar Bajic: Yeah, I think on the topic of safety, I want to first talk about the digital health platforms. I think that one of the significant limitations to the way that these digital health platforms are working nowadays is that they miss an opportunity to determine what the underlying cause of the ED is. So, you do have to give a little bit of background information, but there's no diagnostics, there's no evaluation to understand why the erectile dysfunction might be happening.

We know that ED, for the vast majority of men, is a consequence of cardiovascular disease. I always refer to it as the "canary in the coal mine." It can be the first sign of a more serious issue, which could... There's solid evidence that shows within five years that a man might experience a heart attack. The reason that this happens is because the hardening and narrowing of the arteries that happens first affects the smallest vessels in the body, and the two arteries that a man relies on for erections are less than a millimeter in diameter. So, they tend to be the first to be affected.

So, if I see a guy with a new complaint of erectile dysfunction and they're not established with a primary care doctor, and they haven't had lipid screening and things like that, that's part of my conversation. We talk about risk factor modification, increasing activity, and reducing or completely stopping things like smoking. A lot of times we end up finding that maybe they did have some underlying high blood pressure, high cholesterol, or maybe even diabetes that they wouldn't have otherwise known about.

So, if somebody's just going online to get a quick prescription, I think there is a significantly missed opportunity there. Those people may not end up finding out they have a problem oftentimes until it's too late. So, I think when you come and see a provider in more of a traditional healthcare setting, we're going to have a little bit more holistic view on that. Certainly, we in urology and in men's health as an area of urology, we're specifically trained to try to identify those things. We also think about things like which of your medications might be contributing? Certain blood pressure pills may be more likely to contribute to erectile dysfunction than others. We can actually work in collaboration with your cardiologist or primary care doctor to figure out a regimen that may control your blood pressure issue, but also not have those sexual side effects.

When we look more at the in-person clinics, many of these advertise a single treatment. For example, radial wave therapy is something that many shops around town here offer, which has been proven in multiple randomized, controlled trials to not be effective for erectile dysfunction. Our guidelines for erectile dysfunction that we follow through the American Urological Association recommend discussion of all the available treatment options, including lifestyle modifications and things like that, and I haven't seen that that type of conversation is happening.

So, people are not being presented with the information they need to make an educated choice about their treatment options in any of these settings. Oftentimes, they're only presented with one option, or a limited number of options, that come at a great cost financially, whereas what they may not realize is that most, if not all, insurance plans will cover at least some treatments for erectile dysfunction.

We see this also in men that have low testosterone. Many of them end up in these direct-to-consumer clinics that charge thousands of dollars. But they don't even know that if they truly have low testosterone, it's a medical condition that's covered by insurance.

So, you really need to go somewhere that's trustworthy, that's going to have your best interest in mind, not only your health but also financial considerations, and really educate yourself on what's out there and more than just a single treatment that is being promised as the cure for all ails.

Dr. Scott Steele: So, let's talk a little bit more about these standalone men's clinics. So, as we talked about, they're very heavily advertised online, commercials, radio, billboards. So, from your research, are these providers, are they urologists? Are they family practice docs? Are they specialists in men health? Are they something else? How would you say does the overall experience in treatment outcomes compare from more traditional things like you get here at the Cleveland Clinic?

Dr. Petar Bajic: Yeah. So, there's been an increasing number of presentations I've seen at conferences and also publications I've seen in the sexual medicine literature that really show that the vast majority of these clinics don't even have a urologist on staff. Many of them are run by people with a variety of backgrounds, everything from internal medicine to OBGYN, to emergency medicine. Some of them don't even have a physician on staff. Maybe not necessarily the ones we have here in town, but some around the country are run by naturopathic providers, sometimes physician's assistants, or others. Some of these treatments that are being offered are being administered by people who really don't have any medical training at all, including medical assistants and things like that.

So, there's really no standardization or regulation of these practices that operate outside of insurance and healthcare the way that we deliver it here at Cleveland Clinic. I think it's increasingly coming into light, some of these factors, and also what's being offered and what the outcomes are.

From what I hear from my patients who come in and have spent thousands of dollars at these clinics is that they were promised that it was going to work. Many of them receive an ultrasound at the initial visit and are shown that their arteries are very small, and then they have the treatment. Then another ultrasound is performed at the end that shows that their arteries are very big, and they must be better. But when they go home and try to actually take advantage of that function, it's not there.

The trick there is that anybody with some creativity and an ultrasound probe can identify blood vessels in the body of varying sizes. If we want to show you something on a screen that tries to sell a certain concept, we can probably find a way to do that. So, I think there is a little bit of misleading happening there.

I mentioned radial wave therapy. So, radial wave therapy is essentially non-focused sound waves, almost like a vibrator type device, that they've been used for a variety of different applications, and really in all the higher quality studies that have been published for the purposes of erectile dysfunction have never been shown to have any significant benefit.

These are devices that require no medical training to operate, which is why most of these clinics use these rather than a more complicated device called shockwave therapy.

Shockwave therapy is a technology that urologists have used for decades to treat kidney stones. What it does is it takes sound waves, but it focuses them on a single point to actually create a shockwave which delivers a higher strength energy to the tissue it's being applied to. In the case of erectile dysfunction, it's been shown in some preliminary studies that it may improve blood flow.

So, there is a relatively solid evidence basis for use of this treatment in the treatment of erectile dysfunction, although it is not yet FDA-approved. Certainly, longer-term studies are needed to confirm that that is a good long-term option.

But unfortunately, the radial wave therapy is being falsely marketed as shockwave therapy, whereas shockwave therapy, pretty much you could only really get through a urologist's office. So, I think patients oftentimes are misled and they don't really understand the difference. Nobody's explaining to them the difference in evidence for one versus the other, the limitations of the evidence for both of them. These are some of what we consider to be what we call regenerative therapies for erectile dysfunction, which is like the new hot thing, exploring and studying and trying to better understand who the right candidates for it are.

So that's, I would say, the most popular thing, and not just in the Cleveland area, but all over the country. A lot of clinics are offering this. There's actually a company out there called GAINSWave that actually does marketing. They work with these small clinics, and they do the marketing for them. They supply the devices. So, you see that name in a lot of these commercials. It doesn't actually refer to a specific device. I have a lot of patients ask about that. That's actually a marketing company.

So, it's a very interesting space. I wish there was an easier way to get the message out to our patients out there, and just men in general, about what's available, what the pluses and minuses of each option are. They really should be informed of the whole menu of various treatment options that are available so they can make an educated decision and understand what are the newer things that maybe don't have as much evidence yet in support of them, what are the things that we've been using since the 1970s and earlier that have been proven by the test of time and have high-quality evidence to support.

Importantly, that really, like most other things we deal with, these are medical issues. They should be covered by your insurance. You shouldn't have to pay 8,000 dollars out-of-pocket. You shouldn't have to take on such a great financial burden when there are options available that are affordable.

Even on the topic of medications, which many patients pay hundreds of dollars for through the digital health platforms, Mark Cuban's new Cost Plus Drugs pharmacy, which is like a mail order pharmacy, I mean you can get 90 pills of the full-strength oral medications for erectile dysfunction for between 8 and 12 dollars, which is 5 percent of what you would pay on one of those digital health platforms. That's with a prescription from your primary care doctor or whoever. So, guys just don't know. I mean they don't know, and we need to continue to spread that awareness.

Dr. Scott Steele: So, what would you say to men who are experiencing urological conditions, but truly they're uncomfortable about having that conversation? So how do we make them feel more at ease about discussing it with the urologist, either face-to-face or virtual?

Dr. Petar Bajic: Yeah. I mean, first and foremost, it's important that we get the message out to men and to their partners who, maybe the men aren't listening, but their partner might be and can share this with them. I mean, these are things that all men deal with at some point in their life. There should be no shame or embarrassment. There are varying degrees of severity, but it's just a normal part of life and it is something that we are used to talking about. Although it may not be something you've talked about before, we talk about it every day.

I understand the concern of running into a friend or neighbor in the waiting room, and you're worried they might ask you what you're there for. By the way, you would not be obligated to tell them at all. But, nowadays, with virtual visits, you could be seen even for a first-time visit from the comfort of your own home. You don't have to come in and see somebody in person.

So, I think there are an increasing number of means by which you can get evaluated by somebody who's experienced in taking a holistic view of your overall health and presenting you with all the different options that are available. It's perfectly fine to start that conversation with a primary care doctor, an internist, or your family doctor. But certainly, if you want a little more specialized information, seeing a urologist is a very reasonable place to start. If you really want to delve into the details of the various options that are available, you can certainly see one of our men's health urology specialists.

There's a lot of great information online, but make sure that it's coming from a reliable source. We've got a couple different webinars that we've done that are available on YouTube and on the Cleveland Clinic website on this topic that you could watch by yourself or with your partner for some background information. There's a lot of great information from any of the national and international professional societies like the Sexual Medicine Society of North America, for example. On the Cleveland Clinic website, there's a lot of great info.

So, educate yourself. If you're getting your information from a place that is trying to sell you some product, particularly if it just seems a little too good to be true, I would really second-guess that and maybe go get another opinion before you commit to spending a lot of money on something that does sound too good to be true. So, yeah, those are my thoughts on that.

Dr. Scott Steele: So, can you talk a little bit more, I know you touched base on this a little bit about the treatment office that we have for erectile dysfunction here at the Cleveland Clinic and how you help to educate the patients and work together in terms of their overall health outcomes. What's the best treatment plan for the individual patient?

Dr. Petar Bajic: Sure. So, first of all, no two patients are the same. When I talk about having a holistic view of the person overall, we need to take everything into consideration, including relationship factors. We take what's going on with the partner into consideration.

Then for the patient themselves, we first want to look for any identifiable reversible causes or modifiable risk factors. So, some of the things that we look at that first visit are there any medications or behaviors that might be contributing to tobacco use, certain medications that can negatively impact directions? We take a look at what's their lifestyle is like. Are they doing any cardiovascular exercise? There is some evidence that for mild erectile dysfunction, increasing the amount of cardio that you do a couple of times a week can be beneficial.

Once we've assessed all those things, we want to think about whether or not there is a hormonal cause. Many men, as they age, their testosterone level can decline. Although that's usually not the primary culprit when it comes to erectile dysfunction, it can contribute, particularly if they have other symptoms that might be suggestive of a low testosterone level. So that's something we can check with a morning blood test.

Then once all of those things have been ruled out, if it just seems like routine blood flow-related ED, which is the most common cause, usually most men want to try a medication first. Like I said, there are very affordable ways of getting those medications as cheap as 10 to 15 dollars for a 90-day supply.

There are some men, however, that either due to some other medical issue cannot take oral medication like that, or they just prefer not to rely on medications, or maybe they've tried them and just were not happy with them because they didn't find them to be effective. That's where the options get a little bit broader.

For those men, in very select cases, that may be somebody who may benefit from something like shockwave therapy, which we do for select individuals. Usually, it's for men who have mild to moderate erectile dysfunction, who have at least a partial response to a pill, and they either don't like the side effects but otherwise would get a good response to it, or perhaps they're close to what they want to get, but not quite. Shockwave therapy might give them a little bit of a boost and get them where they're looking to go. But it's definitely not a permanent fix. It might be what similar treatments like radial wave therapy might be advertised as.

More traditional treatments that are available for men who fail pills include things like a vacuum erection device, which is an external device that could be purchased and used to create an erection using a vacuum, and then basically using a constrictive rubber band to hold the blood in. Those are cumbersome, but some men find them to be beneficial.

There's also penile injection therapy, which is a stronger medication injected directly into the penis. Then there's also an option of something called a penile implant, which is a procedure that takes anywhere from 30 to 60 minutes in general, is outpatient, and very well-tolerated. That's been around since the 1970s. Nowadays there's about 30,000 of those done every year in the United States. So many men have no idea that that's even an option. That, for example, is associated with very high satisfaction rates depending on the study, anywhere from 80 percent to 99 percent satisfaction.

So, there's a lot of great options out there, and it's important to educate yourself about what those options are before you make a decision that's going to be very costly for you, either financially or wasted time and things like that. So, that's pretty much the menu as I would present it to a patient. Certainly, there are some nuances there. Everybody's a little bit different. But that's generally the stuff that we talk about.

Dr. Scott Steele: So now it's time for our quick hitters. Since you're a two-time, we'll give you a slightly different question. So, first of all, salt or sweet?

Dr. Petar Bajic: I'm going to say salt.

Dr. Scott Steele: What is your favorite movie?

Dr. Petar Bajic: Oh. I'm going to say Star Wars: Empire Strikes Back.

Dr. Scott Steele: What was your first car?

Dr. Petar Bajic: First car was a Toyota Camry.

Dr. Scott Steele: Tell us if you have a hidden talent that most people don't know about.

Dr. Petar Bajic: I'm double-jointed.

Dr. Scott Steele: Okay. I did not see that one coming. So fantastic. And so, with that, can you give us a final take-home message to our listeners about this entire project that's going on here?

Dr. Petar Bajic: Sure. So, if you have any kind of concern regarding your sexual health, the keyword there is health. This is a part of the human body and some of the things that can go wrong. It can be related to age or related to some of the health conditions that come with age. Initiate that conversation with your primary care doctor or a urologist, and we'll make sure that we're not missing something serious that could be going on in the background. We want to make sure that you have a long and healthy life and that you can also enjoy not only quantity of life, but quality of life. Certainly, from our perspective, those two things go hand-in-hand, and we need to optimize both. So, on that, I thank you very much again for the opportunity to be here with you guys, and always a pleasure.

Dr. Scott Steele: Yeah. And so, for more information about men's health at the Cleveland Clinic, please visit clevelandclinic.org/menshealth. That's clevelandclinic.org/menshealth. You can also call the Department of Urology at 216-444-5600. That's 216-444-5600. Petar, thanks so much for joining us again on Butts and Guts.

Dr. Petar Bajic: Thanks, Scott.

Dr. Scott Steele: That wraps things up here at Cleveland Clinic. Until next time, thanks for listening to Butts and Guts.