Advances in Overactive Bladder Treatment with Dr. Suzette Sutherland

In this episode, I sat down with Dr. Suzette Sutherland, a seasoned urologist who recently transitioned from the University of Washington to a large urology group in Arizona. Dr. Sutherland shares her expertise on treating overactive bladder (OAB) and the latest innovation in neuromodulation therapies, specifically focusing on the efficacy and safety of tibial nerve stimulation. We discuss the evolution of treatment guidelines, the pros and cons of various therapies, including medications, Botox, and sacral nerve stimulation, and dive deep into the promising results from the FDA-approved Revi device from BlueWind. Dr. Sutherland also sheds light on patient selection, procedural details, and patient compliance, while offering insights into the future of OAB treatments.

For information on the REVI   https://bluewindmedical.com/

Timeline:

00:30 Introduction and Guest Introduction
01:10 Understanding Overactive Bladder and Treatment Options
02:19 Tibial Nerve Stimulation: A New Approach
02:40 Changes in Treatment Guidelines
05:57 Mechanism of Tibial Nerve Stimulation
09:38 Implantable Tibial Nerve Stimulation Devices
13:39 Patient Experience and Compliance
17:54 Comparing Neuromodulation Devices
25:37 Comparing Revi and Eco Devices
26:32 Understanding Device Placement and Stimulation Frequency
27:18 Battery Life and Replacement Concerns
29:33 New Devices on the Horizon
30:03 Meta-Analysis of Tibial Nerve Stimulation
32:49 Patient Choices: Sacral Nerve Stimulation vs. Tibial Nerve Stimulation
38:22 The Role of Botox in Bladder Treatment
46:14 Challenges and Innovations in Urogynecology

Transcript

 hi there. I'm here today with Suzette Sutherland. So Suzette is a physician who was the director of female urology at the University of Washington for the last 12 years, and she has recently transitioned to be part of a large urology group in Arizona. And she's also doing some consulting with different medical devices in the urology.

Arena, including blue wind, which makes one of the tibial nerves stimulate. And we're gonna be talking about overactive bladder and tibial nerve stimulation. So welcome Suzette. It's good to see you. Thank you. I'm so excited to be on your show. Thank you so much. So, you know, let's just start real quick about talking about incontinence and overactive bladder and what these devices help fix.

We're talking about this space of overactive bladder, right? I think your audience here knows what that is. Overactive bladder urgency, frequency, getting up at night, and then urgency urinary incontinence that don't make it to the bathroom in time when I get that urge. And we have lots of treatment options for that.

And you know, the treatment options per the. A UA Sufu, our Society of Urodynamics, female urology in short, uh, came, has come up with guidelines and they just revisited these guidelines. Again, looking at what's there in the literature, but they're pretty much the same in that we always start with conservative stuff.

You know, dietary, behavioral things, so on and so forth. And then we move on into other interventions that are considered low risk and then move up into the what might be considered a little bit more higher risk. Traditionally, we always had medications as the next step, and we recognize that there's really low risk for some of these.

Tibial nerve stimulation options. And so putting that into this next bucket is one of the biggest changes with these guidelines, and that's because we've seen such great success and low risk with the tibial nerve stimulation option. So to your point, that's what we're here to talk about today. Yeah. And also take note of where is it placed in our algorithm?

Right. People no longer have to fail. How many medications? Before they can move on into the next bucket, which used to be called third line therapy, which included all forms of neuromodulation. Even this simple PTNS acupuncture thing, right. That we have done for years. Yeah. Sacral nerve stimulation and Botox.

So the idea with the implantable tibial nerve stimulation was also off of the. PTNS, the percutaneous tibial nerve stimulation, which is like the acupuncture, is that the risk is so, so low and proven to the FDA, that it's moved it down in the algorithm so people don't have to fail these things anymore before they are able to get these therapies, at least by our academic.

Guidelines. Now we're trying to now work with insurances to honor the guidelines and say, okay, we'll pay for it. You don't have to fail three meds first. Yeah, that's exactly what I was gonna say. So it used to be you always had to try two to three medications and had to fail those medications, meaning they either didn't work for you or you had such significant side effects that it wasn't a good option before we could move on to one of the other treatments, even if the other treatments.

Even if you were someone who really didn't wanna take medications. But that's, that is changed now and that's true for all tibial nerve stimulation, even the implants. Yes. Yeah, they're all, and that was with the approval, the FDA approval of the Revy device with blue wind that was in the labeling. They got that to be approved in the labeling.

You're able to, you know, trial the neuromodulation with implantable tibial nerve stimulation, or treat patients with this before, you know, without having to fail. The traditional algorithm. Now, clearly what I want, you know, I'm, I need to make clear to everybody so people don't get a misconception that, of course, we always start with this simple stuff first.

You know, dietary things. Yeah. If someone's drinking four or five liters a day, no wonder they're pee so often, right? You don't implant somebody for that, so you need to be smart about it. You're a clinician. You look for all these other simpler things. Where can we make some changes? But we no longer have to force patients to use medications before trying something else.

That's a procedural, small, simple procedural, and again. It's because of the safety, right? Yeah. That algorithm that was developed, really when you look at the different buckets, it's based on safety and element of risk. And at one point everybody thought neuromodulation should all be under one risk. Yeah.

But it's really not. And so reevaluating that pushed it up a little bit higher. And some can argue there's more risk with some of the anticholinergic medications than just doing simple tibial nerve stimulation. Yes, that's definitely true, especially in older patients. Right? I, I am very reluctant to start some of those medications.

I'm gonna ask you a question, and this is a question that I get asked all the time. When we do tibial nerve stimulation, we're stimulating a nerve in the ankle and that helps overactive bladder symptoms. How does that work? I think most patients are so surprised to realize that that is a treatment option.

So when, when I talk to patients, I just focus, you know, my hands can't see me, but focus around the middle, around the bladder area and I say we're stimulating nerves to the bladder and, but we're just accessing it from a very peripheral. We know if you wanna know the name of the anatomy, the posterior tibial nerve runs behind the ankle, bone up the leg, and then it actually is a branch off of this, what we call pelvic plexus, this pelvic bunch of nerves.

And so that's what we're stimulating. We're just getting it from a very peripheral point when we're doing it with PTNS. I do. Talk about it as an acupuncture like device, just because that really translates very well with patients. I'm up here in the very groovy granola Pacific Northwest, and so a lot of patients do acupuncture for all kinds of things and other alternative forms of medicine and successfully so, right.

So they get that and they also get, you can put a needle someplace on my body and it's helping me maybe in my foot, but it's helping my ma my grades, right. So it's the same idea. The implantable tibial nerve options are just allowing patients to do the therapy at home on their own. That's what it is. And what do you think about the transcutaneous options?

Right? So the percutaneous is putting a needle in the leg, but then you can also do it transcutaneous, where you're stimulating the, the skin without actually, um, puncturing the skin. Yeah, I, you know, I should have reviewed some of that data too, in all fairness for this presentation here. But, um, you know, it works all of these forms of neuromodulation work, but it's just to what degree.

And so when you look at the data, when I first, there was just a recent, relatively speaking, over the last six months, I think publication in the Journal of Urology looking at transcutaneous stimulation. When you look at the data, the severity of the patients isn't the same as the patient population for eco or implantable revy.

And then the results. Aren't as significant. Right. So does it work? Yes. But I think it's about patient selection and then patients, what do they wanna do? If they're going to get some benefit but not be a hundred percent fixed, but they're happy with that. Yeah. You can't argue with that. That's their choice.

Right. So, but I'm about, you know, I think we all are about wanting to give our patients choices, but I'm also very realistic and say. This one's gonna help. This one's gonna help objectively more. This one even more. But here's what you have to do to make this one work more. You know what's gonna fit your lifestyle.

Yeah. What's gonna make you happy? Right. We've seen a number of times in other head-to-head trials for other types of therapy, and we see objectively one is far superior than the other, but subjectively, the way the patients answered the questionnaires, it seems to sort of wash out. I. But if you ask the patients well, you're not dry.

And how bothered are you by that? You know, versus do you feel like you're a little better? A much be, you know, all of our, what we have, that's what we have to use. But then you see quality of life Data seems to be similar, but it's not saying that those two types of therapy are the same thing. Yeah. So what is the, the Revy, so the Revy is an implantable device.

How does that work? Well, it's an inert lead. It's a very small lead that just gets implanted in the ankle. You make an incision, uh, blunt dissection down to the level of the fascia. You open the fascia. Right below the fascia is the neurovascular bundle, but it's wrapped in, uh, quite a bit of fatty tissue.

And we colloquially call it the golden Nugget 'cause that's what it looks like and that's how you know you're there. Uh, and then, uh, you know, there are other anatomical landmarks you can use if you find this leg is really difficult, the attendance, and that's what we teach in these courses. Uh, but really all you're looking at is the golden nugget.

You place the lead on top of it. And then you do intraoperative testing. So there's one of the differences from the other implantable tibial nerve option E coin. You do testing and make sure the patient's feeling it and ooh, ah, in all the right spots, right? Then you suture it in place. It has four little spots where you can put a permanent suture in to the sides of the fascia, and then you close, uh, the.

You let it heal for, uh, about four weeks. We did four weeks on the trial just to make sure everyone was going to be healed. And then they wear like an ankle bracelet, a wearable charger that goes around or stimulator that goes around the ankle. It does look a little bit like the person's on parole, but they're wearing it only for their 30 minute session.

That's what makes, you know, stimulates the lead without the wearable, the ankle bracelet. The lead is completely inert. There's no way it can all of a sudden discharge or something and you know, cause a problem. 'cause it's completely inert on its own. So, so I'm assuming when you do this, you're doing it under local, right?

No other anesthesia, just local. And so you could do that in the office or always in the operating room. The recommendation at this point and on the f FDA a approval trial is, was to do it in a surgery center. Mm-hmm. So they were all done on the trial. That was done, that was, uh, led to the FDA approval, I think it was 25 sites in the Europe as well as in the United States.

And just to keep it clean for everybody. Uh, they were done either in a hospital or a surgery center. And that is what we think is, you know, will it get to an office procedure? I don't think quite the same as the e equine. Mm-hmm. And mostly because I think you're really, I. We've gotten really great results.

No problems of infections where the lead had to be removed and have just been really careful and I think, you know, crossing the T's and dotting the I's and a surgery center is a, a wonderful place to do it as well. You get the support you need. Yeah. Um. So that makes sense. The push is that's where the push is and that's where we are now.

People get really facile with it. Many people have a little procedure room right set aside, and it looks like a surgery center for all practical purposes, but it's just like one door over from their office, right? Whatever you wanna call it. Sterility is the main key there. Yeah, so I will say that the, uh, yes, we do wanna do it under local.

There were a few patients that got some IV sedation on the trial for a variety of reasons. I had one patient out of, I think 15, who got some IV sedation only because she had such anxiety. Her blood pressure really started to go high, so it wasn't. Pain or anything like that. Anesthesiologist, we had somebody present 'cause it was a trial.

Um, and they just said, okay, can I just wanna give her a little whiff of something and get her calmed down? Right. Yeah. And so they did that. But otherwise it's under local. Yeah. Yeah. The operating room can be a terrifying. Yeah. Plays for patients, definitely. It's hard to be awake, I think, in that environment for some people.

So, back to charging or stimulating, how, how long do they have to wear it in a day? So on the trial, again, it was just chosen as a protocol. 30 minutes every day. Twice a day. Twice a day. Now that doesn't mean it doesn't work. If you do it 30 minutes once a day, or if you do it 30 minutes every other day, something had to be chosen so that everybody would do the same thing.

So that's what ultimately was chosen, and we asked patients to stick to that, and there was over 90%, 95%, I think, compliance with that over the first 12 months. After that, we allowed more flexibility and we just asked that you used it at least 30 minutes twice a week. Okay, now. So you think that that would be favorable and patients would be like, all right, I'm gonna do that.

Over 80% of the patients on the trial. Stuck with every day. They continue to do it every day, even though they were given a choice to do it less, less often, did do be more flexible. And that just speaks, I think, you know, a lot of people with this said, okay, all of our other neuromodulation things are set it and forget it.

Even the eco, yep. You put it in and it charge it. It discharges or does a session, 30 minutes every three to four days. So it's all programmed to do that so the patients don't have to do anything. And people thought, oh, the patients are gonna, for Revy, have to do their own session. It's never gonna work.

They're not gonna be compliant. And here we found, gosh, when patients do well, I. They wanna continue to do well. Yeah, they're motivated. They didn't wanna mess with a good thing. They're like, I've been doing it every day. It's super easy. You can be up and walking around with this with it. So it's not that you have to be ankle up like you do with the PTNS.

Did they, um, cut down to once a day or did they stick to twice a day? Uh, some once a day. Okay. Some an hour once a day. Some 30 minutes once a, I know. Well, but we allowed them to, yeah. We said, you know. I'm laughing because we always think more is better, right? And if it half an hour works, let me, and I'm 90% better.

Let me do an hour, right? I mean, I think that's just human nature. Um, and while we're on that topic now that it's been commercialized for a couple years here, almost. Patients are really utilizing it in different ways. The company recommends they use it every day, 30 minutes every day, at least for the first month or so, so that you can see, okay, how good is it gonna be?

And then you can play with it to see what do I need to do to keep it there? And still, there are a lot of patients that are doing it every day, every other, some, every third, which is twice a week and doing okay. Um, yeah, I think I've heard there's some out there that are doing it even once a week. How? But we know.

I was say, how effective is it? Well, very, and that's what I was gonna say. We know with PTNS, it was done once a week. Mm-hmm. But I don't know, in your practice, you know in mind, PTNS was not a game changer. It helps. But you know, the one thing, another thing I wanna take a step back and say, what was the population of these patients?

They were wet. Okay. They had an average of four and a half urgent continent episodes a day. That's what the population, that wasn't the inclusion criteria. The inclusion criteria actually wasn't so significant. But when we looked at who we recruited. The average of four. So, so this is a wet patient population and then they did very well.

So if looking at the data, that primary efficacy outcome was urge incontinence, so wetting, right? Yeah. At six months. And then FDA required safety at 12. And so, you know, our neuromodulation bar is greater than 50% improvement. Right? Yeah. That's historically. And so when we say, oh, it was success. At 50%. What was that?

So 80% of the patients got greater than 50% improvement in their symptoms. 80%. Yeah. So that compares to eco. So Eco's a good product and it has, but there's differences here, right? Yeah. 65% at their six month and 12 months mm-hmm. Was 65%. Mm-hmm. The other thing here is that, you know, we asked why is 50% the bar?

Well, we have to use it for comparability between all of these trials, right? But when we looked at what was the percentage of patients that got greater than 75% improvement, now we're looking at something a little more meaningful. And we have between almost 55 and almost 70% of the patients got 75% improvement in their symptoms.

That's really having the FDA look at why are we using 50% for, you know, subsequent procedures that are coming down the pike. Should we be asking more of them? Again, the FDA is mostly concerned with safety issues, so Yeah. But the other aspect of this is we do do an intraoperative test. So we know we're in the right place.

Mm-hmm. We're not in the zone. We're definitely on top of the nerve and be there's sophisticated programmability associated with this device. Exactly like the sophisticated programming available with Segal nerve stimulation traditionally. Right. Which means we don't just turn, you know, the dimmer switch or whatever the intensity up or down.

We can also change the wavelength of the stimulation and the frequency, right? So anyone who does sagal nerve stimulation knows that allows us to monitor or alter the depth of penetration of the stimulation and the intensity, the, the frequency, uh, where that stimulation is. And so that really allows for us to.

Individualized aspects for the patients, and that's true of this re device. That's not true of the eco device. The eco is a, you can change the intensity. You can get it reprogrammed, they call it still reprogramming, but what you're doing is just turn, you know, turning it up or down, higher intensity or lower intensity, you're putting it above the fascia, you're putting it in the zone where you know the nerve runs, but it's gotta go through the fascia and you're getting a field effect rather than a direct on top of the nerve effect.

So it's gonna take more intensity to get the job done. You still get the job done, but I would argue the data would show it's not quite as rigorous. Mm-hmm. As the blue in, but for some patients maybe, it's awesome. It's really a simple office procedure. Mm-hmm. As you know, I don't know how long it takes you to do it.

They have one video that's, they're calling it a 20 minute procedure. I would say it's more like a 10 minute procedure for people who get going, you know? Yeah. So the procedure, so placing it is very, very quick. I mean, it probably takes seven minutes and then you know, the closure because they recommend a three layer closure because it's the ankle just to, um, optimize healing.

The closure is what takes. The, the rest of the time, right? Yeah. The closure takes longer than the procedure. That's definitely true. Um, so one thing that I don't know about, um, tibial nerve stimulation is do you see accommodation the way you do in sacral nerve stimulation where the body gets used to it and so you really do have to reprogram things at, at one time or another.

We don't have a lot of long term. Yeah. You know, because it's only been DA approved in 2003, fall of 2003. Right. And so, and what you are talking about. From a nerve standpoint. Mm-hmm. It's a theoretical issue. We know there is such a thing as nerve fatigue. Right. But is that what's happening in circle sacral nerve stimulation?

We still, the jury is still out there, but there is. More of a voice about that. So this is why people are looking at, should we be stimulating, even in the world of Segal nervous stimulation, should we be stimulating 24 hours a day, seven days a week, right? Or should we be cycling the device now? We had that conversation with Medtronic, probably 15.

Or more years ago. But you know, these studies are costly and they were the only ones on the market and so on and so, so there wasn't any incentive to do a life. So now this theory is coming back around because the newer forms of neuromodulation, whether it's tibial or a new sacral. Coming down called Nusra.

It is based on that thought, like it's, looks exactly like our traditional sacral nerve stimulation. Less hardware is implanted, but you do do your sessions much like you do in the tibial, Ravi, mm-hmm. Device. Mm-hmm. And so, and for that, that very reason. What do patients need? We're just trying to individualize what you might need isn't what I need.

Yeah, right. Yeah, it's, it's nice to have the, the ability to reprogram it in different ways. So that's the other thing I wanted to add to that is with the reprogram ability, we're also able to salvage patients much like we do with sacral nerve stimulation. In the FDA approval trial, there was almost 20% of the patients had less than 25% improvement in their symptoms at the very one month visit.

And then, uh, they were able to be reprogrammed and, uh, we're able to salvage more than half of those to where they were greater than 50% now. And so. That programmability. Some people might say, ah, it doesn't, it's not that big of a deal, but it allowed us to save a lot of patients, right? Yeah. Who we would've traditionally said, oh, you are a neuromodulation, non-responder.

There's something wrong with your nerves. Right, right. That's what people, I hate it when I hear that. Yeah. It I right. It, we frequently do not get it right the first time. Right. And you, you do need the option to reprogram. Yeah. Do, do you wanna speak to any of the other differences between the two devices?

And, you know, what I'm thinking about is, you know, with the equine, it will fail over time because it's a battery. Um, but that doesn't happen with the revy. So, so, okay. I I, I'm gonna make a blanket statement here again. You already said I'm a consultant for the Revy device. Right. But I will even say I wasn't a huge true believer when they first asked me to be part of this, but I, but I am now because of my own experience and what I saw and what it can do.

And, um, I do wanna save time to talk about the meta-analysis and what the data looks like compared, compared to traditional sacral nerve. You know, I'm a data person and I look at it and yes, I care about how the patients feel, but I also think a lot of these quality of life questionnaires and things, it depends on how they get asked and how they interpret that questionnaire and so on and so forth.

So I always, I don't look at quality of life data in lieu of objective. I want the objective data and we add the quality of life to it and find what's the best thing for the patients. So when we look at the objective data, the equine works. But it just doesn't work quite as well as the re device. And why is that?

I already alluded to, you know, there were 65% responder rate versus 80 at a year. Um, they also quote their dry rate, but the dry rate is based on three dry consecutive days, three day diary. It doesn't mean that the patient's never had a wedding episode, right? It's just in that three days. And in all fairness, that's what Revy used as well, and they have it compared to, initially they talked about e coined a 20% dry rate, and then at 12 months it went up to 40%.

I'm not sure what happened there, what that 'cause it's. But in the Revy device, at the 12 months, it's a 50% dry rate. So 50% dry on three days. Mm-hmm. So in all fairness, they had about the same patient population. 4.2 urgent content episodes a day versus 4.5. When you looked at the subject of data, the eco says 70% of those patients said, I'm a little better.

I'm better. I'm much better, right? Those are your categories. 70% fell in one of those three categories at 12 months compared to 95%, right? For the revy. So again, there's the data, right? Mm-hmm. And so we look at it, that's what's happening there. Now, why is that? Okay? Eco is above the fascia. I already had that discussion.

The revy is below the fascia, right on the neurovascular bundle. So you can argue you're getting more nerve direct contact versus you are getting a field effect. Number two, the revy for this, this, these numbers I'm comparing were for the trials, right? For the revy. You're being stimulated daily every day, right?

Twice a day. Eco, it's every three to four days. And it was like that on their trial too. So I mean. You think, wouldn't you get a little more bang for your buck if you got a chance to do it more often? Yeah, right. It's not always the case, but oftentimes it can be certainly in a situation like this. Right.

And then to your point, what you said. Eco is a battery and it's a fixed battery, and the battery, you know, it lasts, they say three to five years. Some things from the company have set out to seven years. I know clinically people who are doing it in patients and what they tell me, they're saying, you know, you get three years, if you're lucky, it's more like one to three years, and it's all gonna depend on how high the intensity has to go.

Right? You're putting that dimmer switch up, but if you put up higher, it doesn't last as long. So. That's the limitation of it. And then when you easy to take out, put a new one in the pocket, theoretically, are you causing more scar tissue that that field effect has to go through each time and so it's not gonna work as well.

Theoretically, I wanna be, you know, clear people say this stuff like it's the gospel. Yeah. I'm like, how that you just, you know. So, so that's, it's all pretty new, right? And we're, you know, figuring out what happens when you replace it. Um, but that makes sense that you theoretically could have more scar tissue there.

Yeah. And so, you know, I think when you look at, if you're looking at a wet population of patients, and I, if I'm, if it were me, I'd wanna try to be as dry as I could be. Yeah, if you're talking about some urgency, frequency, and that's it, and it's not so debilitating and I just need a little bit of help, maybe the eco's fine or I get a couple of urgent continents, you know, little dribbles before I get there every once in a while for me, you know, maybe that is.

Enough. I don't need more, but if you're really having wedding episodes, that's why, you know, I didn't really offer PTNS to my really wedding patients. 'cause I knew, yeah, they'd get a little better, but they wouldn't be happy. Yeah. You'd be adding medications. Well, there are two other things coming down the pike.

I think people should just know about them. One from Medtronic, which is very much like their rechargeable system. That's what it is. The small rechargeable that just goes in the ankle. So it's sort of like eco with a rechargeable battery. Mm-hmm. It does have the sophistication of sacral nerve stimulation, so you can change the wavelength and frequency.

So it has that, you know, and then that battery rechargeable, but it should last a long time. I don't know exactly how long. Do you know if it's above or below the fascia? It's above the fascia. It's above. So it's eco. Okay. With a rechargeable battery. Okay. And some programming sophistication. That's how you wanna think about it.

Okay? The in the other one is made by Coloplast, and it has a, below the fascial lead component attached to above the fascia fixed battery. Okay? It gets a little complicated, but the fix, and so when the fixed battery's done, the whole thing has to come out. Then you have to put a new one in and it's ultrasound guided, so you need to learn ultrasound to make sure you're in the right.

None of these to my understanding, have intraoperative testing to make sure you're in the right spots. That, that I know of. It's just the revy. So we'll hear more about those. They're working on their FDA approval trials. Probably another year or so. Um, they've done some training labs to try and introduce these, uh, ideas to people, but I think it's important for people to really look at all of them with a critical eye.

I love it when new products come down the pike and then, but I wanna look at it and say, what's moving the needle? Here. What's changing that's advantageous that we don't already have, you know? Or is it just a me too product packaged differently so that we can get in the market and make money? Right. Yeah, no, I, I agree with that.

'cause it, it should, every device should be better in some way, or at least offer different option to patients. Do you wanna speak to the meta analysis? Uh, I mean, I'll just say really quickly, we published a meta-analysis recently and what it does, it looks at all the published data on implantable tibial nerve thus far.

So there's not a lot right, but looking also at the sacral nerve, and the long and short of it is when you, uh, look, especially at the implantable tibial nerve options compared to the sacral nerve stimulation, the um, efficacy and safety are equivocal. Yeah, and especially when you're looking at the results from the Revy device, right?

Uh, some of the ecos were in there as well, but really, I mean, if we tease it out and look at it even more, you can see, um, that I. Uh, yeah, the efficacy, uh, of the implantable tibial nerve of the revy is really rivaling that of our traditional sacral nerve stimulation, so that's huge, both for OAB and, you know, urgency, frequency, and urgent continence.

So getting to that 50% threshold, the bar, you know, is up in the 70% on both of those and almost up to 90. Or 80%. So, uh, and then the safety was about the same. We know there are less, more, you know, there were some, uh, uh, issues with early post-op things, but they were all. Mild bruising and went away, tender, they all healed.

Um, or were able to be programmed. The discomfort from the stimulation was able to be reprogrammed. That's the beauty of the reprogramming. Yeah. Not just turning the dimmer switch on and off. Um, but, and, and got rid of all of that. So, so you talked a little bit about the meta-analysis. Do, do you still offer your patients sacral nerve stimulation?

You know, I do. Um, I think it's still. A patient choice. Yeah. In the sense, you know, so I see that sort of loosely I, that's not the right way to say it either, but I think patients can't know everything they need to know in order to make a super educated decision like you and I can. I mean, that's ridiculous.

Am I gonna spend three days with them and educate them about all this? You tell them the nuts and bolts of each thing. I think the highlights in the differences between these types of therapy are the sacral nerve stimulation options that we have today are the set it and forget it, right? Mm-hmm. Now, when we say that, that doesn't mean we completely forget.

We know there's reprogramming. You have to have a team, whether it's the team from Axonics or Medtronic and your staff. Dedicated to help these patients when they call and say, it's not working, can I get reprogrammed? What do I need? So there is some must and fuss that happens, but it is just stimulating behind the scenes.

Whereas, you know, the Revy device, um, and there is a newer sacral nerve that's coming down, hopefully down the pike in another year or so, you'll hear more about it where patients have to do their sessions, the set it and forget it appeals to some patients. Even when they look at it and say, well, how much hardware is getting implanted?

Right. It's a lot less hardware than when we first started doing sacral nerve stimulation back in 1996. I was there. I've lived through this whole trajectory. Right? And so it is a lot smaller. It's great. But when patients see it for the first time, it's still quite a bit of hardware that gets implanted versus what you see with the Revi device.

Yeah, right. I think that's a really good point. You know, a lot of times patients just want the details and we don't always give them some of the details that they want. And if you are doing something at home, what we're implanting is much smaller. And if you want something that you set and forget, then it requires a bigger device in your, in your body.

And some people like that, some people don't. Um, right. Do you still offer medications or when you get to that second line therapy, do you really lean towards tibial nerve stimulation? Well, I, I offer the gamut. Mm-hmm. So I let patients know when I meet them for the first time. Here, we have this, we have this, we have this group, this class of things.

Here's the, you know. Main things about it. And then we have this class and so I, I get a feel for what they might want to do. 'cause many patients just think, I just want a pill 'cause it's gonna take care of it. Boom. You know? And then you have direct, I, I always am honest with OAB or patients and say, we, I know we can make you better.

Can we make you a hundred percent dry all the time? I can't say that. Mm-hmm. Right. Yeah. Even if they're dry on a three day diary, they're not gonna be a hundred percent all the time. So yes, I offer them everything. And, uh, in all fairness, I think, uh, most patients do a trial of medications, even though, you know, by the guidelines, they don't have to, unless there's some contraindication to it.

They've done at least one trial of a medication, usually an a beta agonist, but. Um, yeah. But then between the sacral or the tibial, now that we have data that shows equal efficacy for your severe patients, yeah, it used to be do tibial for your mild patients, but if they're really having problems, they need sacral, but that's not the case anymore.

We see that. So I say to the patients, you have a smaller device implanted, but you are in charge of doing your sessions, or you have a larger device implanted up in your back rather than the ankle. It's taking care of the problem behind the scenes, hopefully for you, you know, without you having to do your sessions.

And there's the biggest differences right there. So this chargeable, battery rechargeable, it's a moot point, right? The rechargeable is now I. Lasts so long and don't need to be recharged for. I don't how, I don't even know what that algorithm is anymore. It's so long. Right. So yeah, that's kind of doesn't matter, you know, the fixed battery lasts 15, 20 years now.

Yeah. So why Yeah, no, I mean, you're exactly right. The battery technology has gotten so much better over time and the batteries last so much longer. Um, I think for the rechargeable, there are some devices where you only have to charge it once a year. Yeah, that's because the company will actually call you and remind you that it's time to charge it.

'cause who's gonna, who's gonna remember that? You need to charge your battery on Christmas. What about, and now if you have a fixed battery though, that lasts you 15, 20 years and you're 70 years old. Yeah. It used to be that it lasted you three to five years. Right? Right. Or maybe seven to whatever, but, and so, yeah.

Okay. If you're 45 years old every five years you're gonna get it out and put a new one. Right, right. And then, of course, the MRI compatibility was a huge thing. We always knew it was compatible. We just needed to have the data to show it and a company to go out on the limb and spend the money for the testing.

Yeah. So that we could take the medical legal issues off the table. Yeah, that was a big issue for a lot of patients and just to say that all the devices are that way tibial as well, and all the ones coming down the pike E everybody's MRI compatible. So yeah. Although even though it's MRI compatible, I have had several radiologists, um, be very uncomfortable with it and want additional documentation.

Right. Yeah. I think we're still in kind of a gray zone where everyone is just getting comfortable. Um, with these devices. What about Botox? So Botox is still, um, third line therapy for overactive bladder and urgency incontinence. Do you think there's still a role for Botox? Absolutely. So, I mean, uh, trained primarily as a urologist.

Right, and so we've been using Botox for, I don't even know how many years in my training, even way back when, predominantly for the neurogenic bladder patients. So there's a huge role for that. So we have lots of experience with high doses where we just really wanted to shut that bladder down. Uh, with the advent of being able to utilize it now for non neurogenic bladder, I was, um, privileged enough to be on that FDA approval trial, which was lovely, um, to get it approved for non neurogenic bladder patients.

And it's a great tool, but it is a temporary tool. So it lasts on average, you know, about six months. That's what the data shows. When you only do a hundred units, does it always get you to six months? A lot of times, no. I talk to patients three, maybe four months. So twice to maybe three times a year. You're coming into the office, you're getting it done, and then hopefully good to go.

It doesn't put you into retention. Hopefully it doesn't put you in, in, I meant how to say that sentence. Um, but, you know, really the FDA approval trial showed it was a 6% risk of retention. And really when you look at the data, you know, patients who did have to catheterize did it for uh, days. To a few weeks.

It wasn't like they had to do it for the entire six months. Mm-hmm. And so people lose track of that and they scare patients away from Botox because of the reten. Well you don't wanna have take the risk of retention. Well, you want a risk of the device getting infected and have to remove it out. Right, right.

So, and there are definitely always risk. And I think the retention, there are a lot of patients who retain that are completely asymptomatic and, and so do they even need to self cath? Right. Yeah, so all of these patients too, you know, you're gonna check how well they're emptying before you do any of these types of therapies.

That's part of your initial OAB workup. Right? And so, and to your point, if somebody's not emptying, but they're avoiding. 400 ccs and they leave a hundred behind. I don't care about that. No. Right. It's just, it's always the balance that you're looking at. You're using your brain and figuring out what do you think is gonna happen in this situation, not just go following a blanket algorithm.

Everybody that has more than a hundred, they have to cath. That's ridiculous. Right? Yeah. So, um, but in any case, you asked me when do I use it. I think I do give patients the choice, but I'm also upfront that it's ongoing therapy. Um, I. And a lot of, and and I talk about bladder directed therapy. So in comparison to the medications, it's blocking receptors in the bladder.

Yeah. To get the bladder to calm down. Well, the meds do that, but now you get systemic effects. Right. The Botox goes directly into the bladder. Neuromodulation, whatever form you choose is a pelvic oriented therapy. So you stand to get some other secondary gains if you have some problems in those areas, right?

We know a sacral nerve anyway. It's proven fecal incontinence. We're looking at fecal incontinence with a tibial, there's no reason it won't work, right? Mm-hmm. Because it's neuro, it's all neuromodulation. It's just how are we delivering the therapy? But we're doing the same thing at the level of the pelvic plexus.

So, but any case, so for the Botox, um, you know, I really put it in the hands of the patients. What I find issue with is when there are providers who only do meds and Botox, they don't even dive into the neuromodulation world. I don't put Botox in neuromodulation world. You know, so, and um, that's what they have and they have these patients looped every three to four months, six months, and they just automatic, automatic years after year after year and have never talked to 'em about sacral or tibial nerve stimulation.

Let them go see the person across the street who might do it, at least to get a consultation. Yeah. That's where I think that. You know, things can go awry, but it is a good bladder directed therapy that will definitely work. Yeah. Um, and in this patient population too. Yeah. I, I just think it's so amazing the number of options that we have today to treat patients.

Right. I mean, it used to be behavioral interventions and two medications and, you know, the, there's just so many more treatments, which I think is great because this is such a devastating. Disease for so many women and, and men. Um, and, and so it's nice to have just a, a large number of potential treatment options.

Yeah. You, um, you, you said something about, and men, which I think to point out most the. Patients in these studies are women. All of the patients were women in the Revy FDA approval trial, although it still got a labeling for men and women, it wasn't women exclusive, which was lovely because the FDA acknowledged this is also a, a problem in men, you know, work up their prostate first, make sure it's not BPH, but then you can have the overactive bladder.

So that's an important thing. To note. So this is probably the only study or the only group of studies that's ever been done in women, and then the indication has been extended to men. Right. It's always the other way. Yeah. Yeah. Yeah. It was great that they were able to get, talk to the f fda a, show other data from other things and, and get the labeling for that.

Yeah. As well as the, the other, the, that's a big point with the labeling they got, and the other is that it, it doesn't require an absolute. Following an algorithm of failure of medications. Yeah. Which is lovely. That is great. Yeah. Yeah. So many patients. But the other thing, the other thing I was gonna say about the Botox before we leave, that you asked when do I use that?

I think a good patient population is a, the, you know, little old lady or man I guess, but that's a little riskier. But, um, the, the, the little old lady with dementia already. Mm-hmm. Right. And um, she's already on a plethora of medications that are gonna interact and, you know, and you don't want that risk of worsening dementia, so you put her on an alpha agonist, you don't have to worry about that, but you still have to make sure she gets the med.

Doing some neuromodulation, even if it's a set it and forget it form, it does require to know if it's really working well and you're on the right program, you, you need some super tentorial faculties to make sure that that's I. Really working to the best of its capability. So I know there have been some studies with sacral nerve stimulation looking at the use in demented patients and elderly patients seeing relatively good results.

But I think when you look at it overall, you know, we've all had some of those patients in our practice and it is a struggle. So I think those are the patients that I'm always looking at. How are they really gonna do their bladder might do well on the neuromodulation, but is it gonna be a good long-term solution for them?

Or would they be better served just coming in with their daughter a couple of times a year and getting Botox? Yeah, I, I think that's a great point. And doing Botox in that patient population, um, can make a, such a huge difference in not only that patient's life, but in their family's life or caregiver's life because it makes, it absolutely takes a difficult situation, right.

And makes it that much more difficult when someone is having incontinence. And a lot of times those patients get ignored. Right. Yes. Absolutely. Yeah. Those daughters are always very, very grateful when we can, you know, improve that quality of life for anyone. Um, so this has been great. Thank you so much for your expertise and knowledge.

Do you have anything else you wanna share? Any parting words? Yeah, well I just think it's a super exciting time. I think for a lot of reasons, the medical legal reasons, things that were happening with the FDA, we just saw. A lack of innovation in this area. Um, in urogynecology in general, right? Yeah. But in this area as well.

And with other people coming into the field, other companies and having some competition has really opened the door and things are booming, which is really exciting to see, I think. And hopefully, you know, with the, uh, things getting commercialized, we'll see. Uh. You know, creative use, I like to call it.

Right? And then we'll really see what do the patients need. And then, and the other hope is that, you know. People are able to somehow muster up enough money to do some of these head-to-head trials. So we really have good, robust data. Mm-hmm. Um, our experience as far as showing us what we think that that data would show.

But, um, so I, I, I'm looking forward to that happening in the future. I agree and it is nice to see, um, so many new treatment options and it'll be interesting to see, you know, what parts of each technology kind of rise to the top. Because I'm sure we haven't gotten it quite perfect yet. Oh, there's always room for improvement.

And that's the fun part about this, is just thinking how can we make it even better? So that's what I meant too. When new things come down the pike that people are aware of everything that's there, really look critically at the differences and how is this moving the needle? Or does this company maybe just have lots of money for marketing?

Mm-hmm. Right. And so that's what I think, you know, to be fair to the patients. Um, we wanna do the best we can for the patients. Yeah, always. Well, thank you so much and have a great day. Yeah. Thanks so much for having me. I appreciate having the platform to talk about this. Yeah. Thank you. Thanks.