Making Sense of Advanced Technologies to Integrate into your OAB Program "Presentation" - Kari Bailey, David Sussman & Neil Kocher
November 19, 2024
At the 2024 LUGPA annual meeting, Kari Bailey, David Sussman, and Neil Kocher discuss advanced overactive bladder therapies, highlighting the shift toward earlier use of neuromodulation and tibial nerve stimulation. They emphasize patient selection, multimodal approaches, and the role of patient navigation in optimizing outcomes.
Biographies:
Kari Bailey, MD, Anne Arundel Urology, Annapolis, MD
David Sussman, DO, FACS, New Jersey Urology, LLC, Moorestown, NJ
Neil Kocher, MD, FPMRS, Premier Medical Group, Poughkeepsie, NY
Biographies:
Kari Bailey, MD, Anne Arundel Urology, Annapolis, MD
David Sussman, DO, FACS, New Jersey Urology, LLC, Moorestown, NJ
Neil Kocher, MD, FPMRS, Premier Medical Group, Poughkeepsie, NY
Read the Full Video Transcript
Kari Bailey: Hi. Good afternoon. So we're going to talk a bit about the advanced therapies in overactive bladder. And to set the stage—well, that's us, we've already set the stage. So I think a lot of us think about OAB in a linear fashion. Patient comes in, history and physical, get all of the diagnostic testing and things that you need, treating underlying conditions, and then talk about behavioral modifications, pelvic PT. Then they have a medication, and then they fail a medication, and then they go to another medication, and they fail another medication. And then eventually we make it to what most people will call, quote, "third-line therapy."
So that's going to be Botox, PTNS, ITNS, and sacral neuromodulation. But the guidelines have been updated, and so instead of it being such a linear fashion and having to go back and forth and fail and try all these medications, it really now says we can start talking about these therapies—there we go—right at the beginning of treatment. So if a patient comes in and they have overactive bladder and you think that they may be a good candidate for one of these therapies, it does not have to be third-line therapy.
So one thing we were hoping from today is that we'll stop calling them third-line therapies and more people will be apt to adopt some of these technologies into their practices. However, overactive bladder, it has a vast management strategy, and so I do think that it is important in your practices, if you don't have one, to have a champion of OAB. So having a nurse navigator, a physician who is championing it, whoever it is, an advanced practice provider would be very helpful to help these patients stay along whatever path you choose for them or whichever path they're choosing for themselves.
So today we are going to talk mostly about PTNS and sacral neuromodulation, those advanced technologies. Botox has been around for a long time, there's really no advancement in Botox. If you find one, we'll tell you about it next year. So Dr. Sussman, do you want to talk a bit about refractory OAB and how we define that?
David Sussman: Sure. I think Kari's comments are really right on par because I think overactive bladder is one of those things that we all take for granted a little bit. And unless you do what we do where we see these refractory difficult patients all the time, but if not us, who? We are the end game for managing the bladder and overactive bladder, so I think we need to be really good at what we do. I think the new guidelines are going to help us, I think, do a better job with patients and maybe speed up the process. I think that was one of the reasons for the change in the guidelines is we felt that it was difficult for patients to go through this whole process of meds and meds and go on and on and then finally get to the third-line therapies. We now can skirt that.
With that being said, we all have insurance companies to deal with, and the insurance companies will still be involved in that process and will impact some of our decision-making and how quickly we move. But that being said, we all see patients that say, "I don't want to take a pill every day," or the pill's too expensive, or the side effects are a problem. So I think the new guidelines give us a little bit of a workaround to enable us to be a little more efficient in how we function and do a bit of a better job in managing our patients. So we know that there are a lot of patients that have OAB, and we used to say, "Well, if you have refractory OAB, you fail meds, you fail the conservative things, we'll move you on to Botox, PTNS, and sacral neuromodulation."
Now, we can speed up the process. But again, what's the definition of refractory? Well, it's going to change a bit because it used to be pretty well-defined. Now it really may be the patients that say, "No meds for me," or "Gee, the med's too expensive. Let's look at some other ways to manage my bladder symptoms." And who makes the determination of what is a refractory patient? Well, I think it's shared decision-making. It's us and the patients. What makes sense for them? Some people, the first comment is, "Give me a pill. That's really all I want." Great, we'll try meds, see how you do. Others, it's the opposite. So I think the shared decision-making for OAB management is really key.
Again, the new guidelines give us the ability to manage these patients, I think, better and more efficiently. What's not refractory OAB? I think we all know this, but this is just to remind everybody, neurogenic bladders are not refractory OAB. Now, granted with some of the new neuromodulation techniques, we can treat neurogenic patients more efficiently and effectively because of the MRI compatibility where we couldn't in the past. So what else? Isolated nocturia, polydipsia/polyuria, dysfunctional voiders. Now, there's some discussion about maybe neuromodulation may have benefit for dysfunctional voiders, the jury is still out. People that don't void well, again, could be a reason for neuromodulation as we know the indications are not just OAB, but people that don't void well, non-obstructive retention. And of course, we also have fecal incontinence, which just as an aside, if you take care of these patients, asking about their bowel habits or problematic bowel issues should be part of that discussion because I would tell you about 30% of those patients with true OAB have some degree of FI.
Neil Kocher: And they'll love you for life.
David Sussman: And they'll love you forever. That's right.
Kari Bailey: And they won't talk about it. You think nobody's talking about urinary incontinence? Nobody is talking about fecal incontinence.
David Sussman: It really is remarkable. If you take care of these difficult patients, asking about their bowel habits is critical and an important question.
Kari Bailey: And I don't know, do you guys use any surveys or questionnaires for patients? Do you put that in there?
David Sussman: We do an OAB screener, but just their bowel habits are an absolute integral part of that discussion as we talk about what options they have for their OAB.
Kari Bailey: So you brought up sacral neuromodulation for OAB and urge incontinence and things like that, fecal incontinence. Can you just tell everybody a little bit about what is sacral neuromodulation for people who don't know and some advances that have happened?
David Sussman: Sure. I think we've all seen this. We know that there are two approaches to sacral neuromodulation. To test, either a PNE, which is peripheral nerve evaluation, office settings, surgery center, 24 to 48 hours of a quick evaluation to see if the patients see improvement. Typically, PNEs are done for patients with traditional OAB urgency and frequency, urge incontinence because it only takes a day or so to get a sense of how they're going to respond. The stage ones, again, is that the best thing to do for a patient with retention? Probably not. Probably more of a stage one, the more semi-permanent implant for those patients with either FI or non-obstructive retention. I think the PNEs are more, I think, for the traditional OAB. Do you agree?
Neil Kocher: Honestly, I often start with a PNE. I've found a lot of patients find that to be an approachable and relatively straightforward, at least ease into this. And certainly you can use a stage one, which does require typically an anesthetic event as a salvage procedure. But I've had success with PNEs. I thought the same thing in Cleveland and yet offered it to them. The patient said, "You know what? That procedure's under local, I can drive myself home." Those factors are really super important for a lot of patients.
Kari Bailey: I think it's key. I think patients are talking about going from a med that's very approachable to patients, talking about an implant. Having a PNE, they're like, "It's a nerve test. It's just a nerve evaluation."
David Sussman: Just to see how you respond.
Kari Bailey: There's no harm or foul, so if it doesn't work, it doesn't work. We're going back to where we started.
David Sussman: But you don't expect that patient who has retention to get better. And I think that's the patients for whom probably a stage one makes a little more sense. But I agree, PNEs are easy to do, and they're a quick way to understand how they're going to respond to more of a permanent implant.
Neil Kocher: Just a quick show of hands, how many out there are doing PNEs, basic tests? How many? Way up high. So what's that, 25%? How many want to do it? How many if you, I don't know, were taught, is anyone interested in integrating it in their practice?
David Sussman: I think it's—
Kari Bailey: Hey, got one.
Neil Kocher: These are huge.
David Sussman: It's not difficult to do. And I think really it is a relatively simple technique, which I think has a lot of gains. And again, I think from a patient perspective, they're quite appreciative that you can do this quickly and in the office under local.
Kari Bailey: But it's all about how you bring it up.
David Sussman: Correct.
Kari Bailey: When you tell somebody, "It's an implant, we're going to have to implant something into your body," they're like, "Ugh." But if you're like, "Oh, we'll do a nerve test, and if it works, maybe this is a therapy that's going to work for you," I think it works well.
David Sussman: So who doesn't get neuromodulation? Obviously people that don't respond to stimulation, either a PNE or a stage one, people that are going to have some shortwave treatments of some sort. I think the other important thing is what's really changed with neuromodulation? Two things. The rechargeability, which I think has been, in my patient population, probably only one out of 10 people choose the recharge, but the ability to do MRIs has changed dramatically. So now you can use neuromodulation for patients with MS if you think it's appropriate, patients with Parkinson's. These are the patients that before this you would never use neuromodulation because they're getting MRIs on a regular basis. So those are typically Botox patients or other ways to treat them. Neuromodulation now has expanded its role because of the ability to get an MRI with these implantable devices, and that's changed things a lot. I think it's a huge improvement in our ability to deliver this care.
Kari Bailey: And even the non-rechargeable batteries now last 10 years.
David Sussman: They're 10-year batteries now, right.
Kari Bailey: So that's a huge difference.
Neil Kocher: Even better if you get the lead right, perfect, the nerve and not much juice.
David Sussman: Absolutely. And again, a lot of us learn this in residency, some obviously in fellowship, but this is the ability to do neuromodulation, as Neil will talk about, PTNS is incredible. Again, if not us, who? Yes.
Speaker 4: I didn't know that InterStim was approved for upper motor neuron disease such as Parkinson's and multiple sclerosis.
David Sussman: No, I'm sorry, I didn't mean to imply that. But you can use it for patients that have overactive bladder from a Parkinsonian perspective or MS, where you really couldn't before. These patients are getting MRIs on a regular basis. That was the reason.
Speaker 4: I didn't think that if a patient carried a diagnosis of MS, you could even do a PNE.
Neil Kocher: So to your point, a lot of these patients could have baseline overactive bladder urgency incontinence that then are subsequently diagnosed with, say, a neurogenic condition. And so in my practice at least, I will talk to them about that when they see me, whether or not they had that diagnosis or not, and I still can offer it to them. And there's success. In fellowship we did a study comparing PNE, which older studies said that compared to stage one, maybe not as successful. But if we looked at that and with current contemporary techniques, fluoroscopy, you can get success rates on that trial relatively close to a stage one. But patients with a neurogenic condition can have a slightly lower success rate.
Kari Bailey: And both companies are definitely still specifically with the MS population—
David Sussman: That's the biggest population.
Kari Bailey: ... we're working on that. They're working on that one.
David Sussman: But I think what we know now is though, if somebody has overactive bladder or detrusor overactivity, even as a result of an upper motor neuron lesion, you can still treat them with neuromodulation with some benefit. Again, may not be quite as good as maybe Botox or other modalities, but it used to be that anybody that carried a neurological diagnosis as the etiology of their overactive bladder or urge incontinence, you were not using neuromodulation because of the inability to obtain an MRI. And that was really the big issue. Obviously this is dependent upon you. I never did it with MS, and now I'm doing it more routinely with MS patients—
Kari Bailey: Same.
David Sussman: ... who have detrusor overactivity and urge incontinence because of the ability to have an MRI, which heretofore was not available.
Speaker 4: My concern is that many of us here have our own ASCs, and we're concerned that we're going to get reimbursed. I was part of the FDA trials in '96 on InterStim. And we didn't have much ... I'm a believer, but we just can't get approval for it.
David Sussman: That I couldn't speak to. You're right, that's a different issue.
Kari Bailey: And some insurers, regardless of the guidelines, are going to still say behavioral modifications, two medications. So there are still certain conditions even that are approved for that we're not going to get covered. So it's a lot to consider.
David Sussman: Listen, I think even with the new guidelines, we're still at the mercy of insurance companies and what they allow us to do and not do. But it's a good point. I haven't had any pushback yet on MS patients. I've only done one Parkinson's patient, and I didn't have a problem, but it's a good point. I thank you. Appreciate that. So again, who else? Not a good idea for neuromodulation: pregnancy, pediatric, etc. Anyone doing bilateral stimulations here routinely or sending people home with bilateral implants with batteries on both sides? There are some people in our world that do them routinely. I haven't found them to be effective or more effective than that.
Neil Kocher: Limited data.
David Sussman: There's not a whole lot of data about that. And who's a good candidate? Again, we know this: failed medical therapy, although today maybe not so much, fairly compliant, willing to follow up and work with us and be willing to go through the adjustments and programming changes that go through it. But again, I think the other thing to keep in mind is fecal incontinence, which I think has shown fairly good results in the population of patients who have non-obstructive retention—
Kari Bailey: I'll say insurance-wise for fecal incontinence, you don't have to jump through as many hoops.
David Sussman: That's true.
Kari Bailey: If they have fecal incontinence, it doesn't matter if they've failed any medications from whatever insurer, it's first-line treatment. So they'll go straight for that.
David Sussman: So again, I think with this change in the guidelines and the fact that we now, I think, continue to have some expansion in our ability to treat, as Neil will talk about, with PTNS and some of the changes in neuromodulation, I think it's going to expand our ability to help these patients. And of course, Botox when appropriate. And by the way, there's nothing wrong with multimodal therapy, just like hypertension. But have those discussions. I have patients typically from Dr. Brown who need neuromodulation, Botox, and meds, and some people require that combination to really achieve the goals they're looking for. So I think all of these things are part and parcel of what we can deliver in the stage of overactive bladder. And again, people who are not good candidates: obviously people who may not respond well to either a PNE or stage one, some sensory deficits, pelvic pain, significant comorbidities, again, neurogenic bladders. We talked about maybe your role obviously with the ability to do—
Kari Bailey: I think that just bridges to the next therapy is that poor surgical candidates. So you have a patient who can't go to the operating room or doesn't want to go to the operating room, Neil's going to talk a little bit about some PTNS, and we all know PTNS, but ITNS, and tell us a little bit about that.
Neil Kocher: A new thing.
David Sussman: You're up.
Neil Kocher: All right, so let's move a little forward here.
David Sussman: I think I had some ROSETTA data for you, but we can go through that.
Neil Kocher: All right, so hopefully everyone's familiar with percutaneous tibial nerve stimulation, been around the block for quite some time. The hot new kid on the street is the implantable devices. So this ITNS therapy, so novel therapy used for urgency incontinence, OAB. It's minimally invasive. I do them under local. These are implantable devices. They offer an at-home therapy. So for folks who are coming from long distance or can't spend 30 minutes or more every week in the office, this can be with or without, say, the patient being involved. So certain devices out there, and there's a lot more coming out, have where a patient can adjust or not. Currently, two are on the market, but again, there are many more on the horizon. And the whole idea is to optimize this, to decrease that patient burden, to get their therapy and overall improve quality of life.
So one device, the first to come out was this eCoin, and here are the data that were published several years ago. And at one year, we had 70% with greater than 50% improvement. That's that cutoff we use to document success. 20%, a little over, were dry, just relative data that Botox, the OnabotulinumtoxinA, that's about 40%, give or take, based on those data. So that's pretty good. And again, this takes 20 minutes to do, and 90% were satisfied, would recommend. There's a little bit of some data that was affected by, of course, the pandemic. It was not blinded, and there was a 3% explant rate.
Next one on the market looks like a little, I don't know, house arrest monitor, this Revi device. But ultimately at one year, again, 82% showed a 50% improvement. These data are quite good though. 50% dry, 95% satisfaction, high compliance. But again, similar unblinded and 4% device-related.
David Sussman: I think one of the differences between eCoin and the Revi, the eCoin sits above the fascia, and the Revi sits below the fascia. It sits right on top of the nerve. And this is just my opinion, I think it's going to be ultimately, I think that may be one of the reasons for the better results.
Neil Kocher: It's possible, yeah.
David Sussman: I just think that to me—
Neil Kocher: It's so new.
David Sussman: It's so new. We don't know.
Kari Bailey: And battery life.
Neil Kocher: Correct.
David Sussman: And battery life.
Kari Bailey: But that'll happen.
David Sussman: eCoin has a relatively short battery life.
Neil Kocher: They say about—
Kari Bailey: Three.
Neil Kocher: ... five years or so, if you can get it pretty low. So I just have a quick video. This is in my surgery center doing the first device, that eCoin. So you basically mark it using their little template. And patient's awake, clean the skin, numb them up with a little local, prep really well, go from proximal to distal, really getting the area that you're working on. The patient drove themselves and back, by the way, to get this procedure, which I thought was pretty interesting. So you can just cover the toes, a little sterile thing and just get your sterile field going. And then essentially once you're sterile, you just remark using another template, and then incise right over that incision, and to your point, going just down to the fascia, which we'll see in just a second here, but with tips up just dissecting that plane.
I think the surgery center was wondering what the heck a urologist was doing on the ankle. But here we are. So you can see the fascia there quite well. Very nice dissection. And then you use this little blunt dissector to go down towards that mark, that circle where I'm aiming to is where the device actually will go. They designed it such that the incision was away from where the implant will go, and you just go right to your finger without over-dissecting, just with some steady blunt pressure staying right on that fascia. Wash it out—the solution to pollution is dilution. And then essentially you can ... Well, every time I put an implant in, I don't know how y'all do it, I change my gloves, but putting that device right in that pocket and then seating it down into the area that was dissected. And then you close it up, and so you want to box it in, grabbing a little superficial fascia, grab a little of the soft tissue above, and then a multi-layer repair. That honestly takes more time than—
Kari Bailey: Takes the longest time.
Neil Kocher: ... actually doing—
Kari Bailey: For sure.
Neil Kocher: ... the rest of the case. But putting that together, running it closed, and ultimately a little glue and a dressing. So pretty quick procedure, easily approachable. You have to wear this very attractive compression sock for at least about five to seven days. And then typically we activate initially at a month, but now actually we're activating at two weeks. So that's it. Anybody here can do it.
David Sussman: Just a couple of quick thoughts about it. I think as urologists, Neil's right, we're not used to working on the leg or the ankle. These do pose some healing issues. And I will be honest, I think we have to be a little careful about who we choose. I live in southern New Jersey where the older folks' ankles are not the prettiest things in the world. So between peripheral vascular disease, venous insufficiency, and diabetic neuropathies, you have to pick and choose your patients carefully because they have to heal. And we're not used to managing or dealing with wounds of the ankle as urologists. So just a thought, I think you just want to be careful and choose patients somewhat cautiously.
Neil Kocher: They heal a lot slower.
David Sussman: They do.
Neil Kocher: The ankle incisions heal remarkably slower than, say, your incision for sacral neuromodulation or anywhere else in the body. So to your point, I have a patient of mine I saw a couple of days ago that even a month later, it still looks pretty fresh.
David Sussman: They tell you to elevate the leg for a couple days, stay home and elevate, which is sometimes difficult. So again, I think it's a great technology, but there are some pitfalls that everyone should be aware of. And I think, again, we're not orthopedic people. We're not used to this stuff. So I find myself looking at ankles a lot and thinking, nope. A lot of no's in my practice.
Neil Kocher: A physical exam really can—
David Sussman: Yeah, it makes a difference.
Neil Kocher: ... therapies.
David Sussman: It does.
Kari Bailey: Summertime's a little easier to come in.
Neil Kocher: Do you want your slides back up?
Kari Bailey: Yeah, we'll put the slides back up. But so now we set the stage for these therapies, and now we've changed the way in which we may talk to patients. So when you guys see a patient, do you talk about these right off the bat? Do you first—
Neil Kocher: Absolutely. Let's say you have someone who comes in, and let's say they have mixed incontinence, they're not sure which—a history is huge. You can pretty much figure out, for the most part, what minus maybe positional incontinence as we were discussing earlier. But definitely getting a good history, doing your physical exam, and then introducing everything. We have a printout, we have an algorithm, we have an OAB navigator that is available and has a centralized database on what patients and where they are in the pathway. But getting that idea of an implant or an advanced therapy right out of the gate, the next time they come and see you, it's a lot less radical. It's a lot less of a big wow factor.
And just another thing that I've figured out in my practice is having another implantable device relative to sacral neuromodulation has really changed patients' perspective on an implant itself, in that I'm getting a lot more either PNEs or sacral neuromodulation or, let's say, the implantable tibials, just because instead of it being Onabotulinum or a sacral neuromodulation and those, now you have 50%, two out of those of the four with PTNS are implantable devices. So it's really changed that patient psychology, consumer psychology, and getting a lot more implants because of it. So kind of interesting.
Kari Bailey: I like the education. I try to send them home with that OAB toolbox. Just so you tell them everything, they're inundated, they can't process it all the first time. But what I have found more now that I'm bringing the therapies up sooner, they come back more. So when they think the medication doesn't work, a lot of them were like, "Well, I didn't know there was anything else." So they are lost.
David Sussman: They tell a lot about evaluating practices and how we manage these patients. And if you don't let the patients know early on that you have a wide range of things to treat them, they often don't come back. Especially if they've had a med already and they failed and you don't give them that story, I think they quickly lose faith that we're going to be able to manage them. So I think the earlier you discuss these third-line therapies, which they may change the name now from third-line to just additional therapies—
Kari Bailey: Therapies, yeah.
David Sussman: I think it benefits the patients because they understand that we can help them in almost every case, whether they respond to medications or not.
Neil Kocher: Another quick point, I don't know how many of those in the audience are aware of, but anticholinergics are really linked with increased risk of dementia. And of course, they stratify, being the highest risk, maybe your trospium and others are a little bit less risk. But if patients are finding this information online, then you need to counsel them on that. I think the AUA update that just dropped quoted up to a 20% increased risk with just three months or more exposure. That's mind-blowing. That is insane. So patients are finding this data, and certainly you need to counsel them. And I think that's going to shift towards advanced therapies, especially with insurance coverage being an issue or side effect profiles or what have you. So learning these and being comfortable with these, I think, is really important.
Kari Bailey: And that was what I was going to bring up is a lot of these patients will come and see you. They've been on medication, they've been on Botox. So how do you bring that up to patients, or how do you get them back in the fold? I feel like some of these patients are six months post-Botox. How do you get them back in to discuss this stuff? How do you do that?
David Sussman: Listen, I think it used to be that you'd give somebody Botox, you'd say, "Let us know when it wears off." I never do that. I think we need to see those patients and understand and see them in four or five months. I tell the patients the average Botox is six to eight months, some are longer, some are shorter. I think if you see these patients on a somewhat regular basis, you understand their journey, you get a better sense of when the medications wear off so you can get them the next Botox injection. Same thing with neuromodulation. If you've done an implant and they're doing pretty well, I do see them every six months just to get a sense of where they are.
And my first question is, have we achieved your goals? Are you where you want to be? Have we done enough for you to get you where you want to be? Because sometimes it's going to be making adjustments in the program, adding Botox or adding a medication on top of where they are. So I think it's a constant process. We didn't have much to offer before. You didn't ask them any questions because you didn't have many answers. Now we have a lot of answers, and I think the questions are appropriate. And I think, to Neil's point about anticholinergics, besides the issues with cognition, we need to be concerned about the side effects. Most of my patients are constipated at baseline. I think to add to their constipation is a crime for a lot of these patients to make it right.
Neil Kocher: It's only going to make their OAB worse.
Kari Bailey: And then the dry mouth, they're drinking all the time.
David Sussman: The dry mouth as well, right. So I think these are all things that we need to be cognizant of. And as we counsel our patients, we're the experts. We understand what roles these therapies play. Try to help them make good decisions. Well, the issue, we talked about what's refractory, but I think refractory is when you can't afford the medication, and I think that makes it a refractory issue. I really believe that just because it works, they can't afford it—what's the... Peter?
Speaker 4: I was just going to ask if you could comment on the evaluation of a male OAB patient and do without the quantitative approach.
David Sussman: It's a great point. I think we shouldn't forget that we see a lot of men who have overactive bladder. And again, we all know this story that physiologically a lot of men develop OAB as a result of obstruction. Their bladders become less elastic. We know that story, that a lot of men see it as a result of their obstructive symptoms from their prostate. We also know that there are some men who develop OAB independent of their obstruction. And I think that's a discussion that not a lot of us have but should have because I think it's important to let men know where their symptoms are coming from.
And we also know that if you treat their outlet, sometimes their OAB gets better. Not always. And we can't predict that. Whether you do a UroLift, a Rezum, a TURP, we all know that OAB doesn't always get better as a result. So I prepare those guys with that discussion. But I think you're right, Peter. I think a lot of men have OAB, a lot of the post-RP men who come in with incontinence, we talk to the residents about this all the time, a lot of them have DI because they've had a change in the nerves to the bladder after an RP. And oftentimes you do urodynamics in those men, they're not—
Kari Bailey: That's what I was going to ask you. Do you change your evaluation a little bit from men in terms of more urodynamics or UroCuff or whatever? Do you tend to?
David Sussman: I do.
Neil Kocher: I think so.
David Sussman: Because I think the discussion's often going to be you have an outlet obstruction, and you have OAB, two different issues. Now how are we going to deal with this? How are we going to approach this? And the order in which we approach it, I usually tell men that treating their outlet effectively will then help me treat their OAB more effectively.
Neil Kocher: That can be a tough sell too, because patients come in with urgency, nocturia, all of the classic bladder outlet obstruction. They're like, "I think my flow's fine." And you do objective studies, and you're like, "Dude, it's terrible. I don't know what you're thinking." And then they go, and they get a procedure and may, again, not improve their OAB. So it's definitely a challenge, it's a balance, but you can definitely treat the OAB at the same time. But addressing that outlet is important.
Kari Bailey: I find UroCuff is kind of nice.
Neil Kocher: Very nice.
Kari Bailey: Because they don't have to do it through the urodynamics testing. It is a really quick procedure just to say, even sometimes for the insurance companies, it's not obstructive.
Neil Kocher: And there are newer devices coming out that are ambulatory urodynamics. So there are going to be new commercialized devices where they'll eventually go home with that, and you get a little bit more of a finer granular data on whether they're obstructed or not because urodynamics isn't perfect. We know that.
David Sussman: I think we underutilize urodynamics in men personally. I think that there's a lot of men who probably would benefit from urodynamics that we don't do, yet we have a tendency to order it on women very easily. I think that's a little bit of an issue that we all need to address. And there are men, I think, again, who have complicated voiding issues. Certainly the previous surgeries, whether it's RPs or other kinds of pelvic surgery or just the obstructed guy, but whose symptoms are more OAB than they are obstructive in nature.
And I think UroCuffs have a role in the more index patient, urodynamics in a little more complicated patient. I think we all have gotten around to doing more TRUSes and cystos as part of that evaluation, as the AUA guidelines have changed for BPH. So I think we're doing a much better job overall as the guidelines have given us the imprimatur to say, "You know what? We do need a TRUS and a cysto and maybe urodynamics for that patient."
Neil Kocher: And the therapies just keep getting better, right?
David Sussman: They do, absolutely.
Neil Kocher: So improved meds, improved advanced therapies, at-home availability. So the future's very bright for OAB management.
Kari Bailey: So we lost our slides, but the take-home points from this talk that we were hoping to get across were that it's no longer third-line therapy. So thinking about it in a different way, shifting the way in which we talk to patients. There have been many advancements in the field in terms of making the devices better. I think a lot of people trained in an era where sacral neuromodulation was not as good as it is today and maybe have a little bit of a misconception as to how effective it is. And I think that's something really important I have found with some of my partners. And just having a point person, bringing people through the thing. And then really we're underutilizing this technology. We're underutilizing treatments that help patients, so we need to do better.
Speaker 5: Do you have a navigation system within your practices to try to help identify these patients prospectively? Because obviously you guys do this at a very high level, but not everybody over a wide geographic area or over a large practice can do it as well as you do. So how do they get to you other than just referral? What does that process look like in terms of—
Kari Bailey: So for my group, we've brought into a chronic care management program. So I try to sign my patients, specifically OAB patients, up for the chronic care management program, so that they can move through these therapies and not get lost to follow-up in that way. It's reimbursed, so we're able to have staff that are able to check in with these patients. I think a lot of programs have a nurse navigator, but again, you have to be able to... And listen, if you have a nurse navigator who gets these patients in the door, you're going to cover the cost of having that person in your group. So I think that, head and shoulders, absolutely. But for us, we use that chronic care management program a bit. How do you guys do this?
Neil Kocher: Nurse navigator, yeah.
Kari Bailey: Nurse navigator.
Neil Kocher: And really I think, as you mentioned, having scheduled follow-ups. I'll see my Botox patients, and I'll be like, "All right, see you next season. Spin the wheel on your Botox, see when it wears off."
David Sussman: I think you're right.
Neil Kocher: Every injection is a little different, but they'll get a feel for it too.
Kari Bailey: But I also use the chronic care management, and I send them a message, "Hey, check in with this person in five months. Find out where they are. Hey, and while you're at it, let them know there's another therapy that if they want to discuss it with me, come back in."
Neil Kocher: Plant that seed.
Speaker 5: Lastly, you had alluded to, I think David had mentioned, the ROSETTA data, which really is looking at comparison of—I think this is not really my field—but Botox to sacral neuromodulation, correct? Could you help us understand that data and what that looks like just briefly before our time ends here?
David Sussman: So ROSETTA was an interesting trial. It looked at neuromodulation versus—unfortunately, they used 200 units of Botox, which is not the standard dose. So the ROSETTA trial is a little hard to interpret. It looked a little better on the Botox side, but again, I think they used 200 across the board.
Neil Kocher: Non-neurogenic.
David Sussman: Right, non-neurogenic indications. So I think the data was a bit skewed, but I put it out there just to remind us that look, these therapies have been around a long time, and we're constantly looking at one versus the other. Sometimes they're complementary, quite frankly. And I think I can just tell you in my practice, and I think my colleagues will agree, when you start to get a sense of what people are interested in, some people you say the idea of Botox, and they're like, "No, I don't want to be injected every six or eight months." Others, the idea of an implantation makes them crazy. So I think you have to get a sense of what works for the patient, but I do also recommend that we tell patients it's multimodal therapy and they need it because their symptoms are so problematic that they need to be more than just one.
Neil Kocher: There's a synergism.
Kari Bailey: And that's what I like to talk to patients about too. When they get overwhelmed, we're not tied to this. If you do a PNE and it doesn't work well for you and you decide not to do it, it's fine.
Neil Kocher: They're all good options.
Kari Bailey: Botox, when your Botox wears off, we can do sacral neuromodulation. So I think it's a lot of good therapies out there.
Kari Bailey: Hi. Good afternoon. So we're going to talk a bit about the advanced therapies in overactive bladder. And to set the stage—well, that's us, we've already set the stage. So I think a lot of us think about OAB in a linear fashion. Patient comes in, history and physical, get all of the diagnostic testing and things that you need, treating underlying conditions, and then talk about behavioral modifications, pelvic PT. Then they have a medication, and then they fail a medication, and then they go to another medication, and they fail another medication. And then eventually we make it to what most people will call, quote, "third-line therapy."
So that's going to be Botox, PTNS, ITNS, and sacral neuromodulation. But the guidelines have been updated, and so instead of it being such a linear fashion and having to go back and forth and fail and try all these medications, it really now says we can start talking about these therapies—there we go—right at the beginning of treatment. So if a patient comes in and they have overactive bladder and you think that they may be a good candidate for one of these therapies, it does not have to be third-line therapy.
So one thing we were hoping from today is that we'll stop calling them third-line therapies and more people will be apt to adopt some of these technologies into their practices. However, overactive bladder, it has a vast management strategy, and so I do think that it is important in your practices, if you don't have one, to have a champion of OAB. So having a nurse navigator, a physician who is championing it, whoever it is, an advanced practice provider would be very helpful to help these patients stay along whatever path you choose for them or whichever path they're choosing for themselves.
So today we are going to talk mostly about PTNS and sacral neuromodulation, those advanced technologies. Botox has been around for a long time, there's really no advancement in Botox. If you find one, we'll tell you about it next year. So Dr. Sussman, do you want to talk a bit about refractory OAB and how we define that?
David Sussman: Sure. I think Kari's comments are really right on par because I think overactive bladder is one of those things that we all take for granted a little bit. And unless you do what we do where we see these refractory difficult patients all the time, but if not us, who? We are the end game for managing the bladder and overactive bladder, so I think we need to be really good at what we do. I think the new guidelines are going to help us, I think, do a better job with patients and maybe speed up the process. I think that was one of the reasons for the change in the guidelines is we felt that it was difficult for patients to go through this whole process of meds and meds and go on and on and then finally get to the third-line therapies. We now can skirt that.
With that being said, we all have insurance companies to deal with, and the insurance companies will still be involved in that process and will impact some of our decision-making and how quickly we move. But that being said, we all see patients that say, "I don't want to take a pill every day," or the pill's too expensive, or the side effects are a problem. So I think the new guidelines give us a little bit of a workaround to enable us to be a little more efficient in how we function and do a bit of a better job in managing our patients. So we know that there are a lot of patients that have OAB, and we used to say, "Well, if you have refractory OAB, you fail meds, you fail the conservative things, we'll move you on to Botox, PTNS, and sacral neuromodulation."
Now, we can speed up the process. But again, what's the definition of refractory? Well, it's going to change a bit because it used to be pretty well-defined. Now it really may be the patients that say, "No meds for me," or "Gee, the med's too expensive. Let's look at some other ways to manage my bladder symptoms." And who makes the determination of what is a refractory patient? Well, I think it's shared decision-making. It's us and the patients. What makes sense for them? Some people, the first comment is, "Give me a pill. That's really all I want." Great, we'll try meds, see how you do. Others, it's the opposite. So I think the shared decision-making for OAB management is really key.
Again, the new guidelines give us the ability to manage these patients, I think, better and more efficiently. What's not refractory OAB? I think we all know this, but this is just to remind everybody, neurogenic bladders are not refractory OAB. Now, granted with some of the new neuromodulation techniques, we can treat neurogenic patients more efficiently and effectively because of the MRI compatibility where we couldn't in the past. So what else? Isolated nocturia, polydipsia/polyuria, dysfunctional voiders. Now, there's some discussion about maybe neuromodulation may have benefit for dysfunctional voiders, the jury is still out. People that don't void well, again, could be a reason for neuromodulation as we know the indications are not just OAB, but people that don't void well, non-obstructive retention. And of course, we also have fecal incontinence, which just as an aside, if you take care of these patients, asking about their bowel habits or problematic bowel issues should be part of that discussion because I would tell you about 30% of those patients with true OAB have some degree of FI.
Neil Kocher: And they'll love you for life.
David Sussman: And they'll love you forever. That's right.
Kari Bailey: And they won't talk about it. You think nobody's talking about urinary incontinence? Nobody is talking about fecal incontinence.
David Sussman: It really is remarkable. If you take care of these difficult patients, asking about their bowel habits is critical and an important question.
Kari Bailey: And I don't know, do you guys use any surveys or questionnaires for patients? Do you put that in there?
David Sussman: We do an OAB screener, but just their bowel habits are an absolute integral part of that discussion as we talk about what options they have for their OAB.
Kari Bailey: So you brought up sacral neuromodulation for OAB and urge incontinence and things like that, fecal incontinence. Can you just tell everybody a little bit about what is sacral neuromodulation for people who don't know and some advances that have happened?
David Sussman: Sure. I think we've all seen this. We know that there are two approaches to sacral neuromodulation. To test, either a PNE, which is peripheral nerve evaluation, office settings, surgery center, 24 to 48 hours of a quick evaluation to see if the patients see improvement. Typically, PNEs are done for patients with traditional OAB urgency and frequency, urge incontinence because it only takes a day or so to get a sense of how they're going to respond. The stage ones, again, is that the best thing to do for a patient with retention? Probably not. Probably more of a stage one, the more semi-permanent implant for those patients with either FI or non-obstructive retention. I think the PNEs are more, I think, for the traditional OAB. Do you agree?
Neil Kocher: Honestly, I often start with a PNE. I've found a lot of patients find that to be an approachable and relatively straightforward, at least ease into this. And certainly you can use a stage one, which does require typically an anesthetic event as a salvage procedure. But I've had success with PNEs. I thought the same thing in Cleveland and yet offered it to them. The patient said, "You know what? That procedure's under local, I can drive myself home." Those factors are really super important for a lot of patients.
Kari Bailey: I think it's key. I think patients are talking about going from a med that's very approachable to patients, talking about an implant. Having a PNE, they're like, "It's a nerve test. It's just a nerve evaluation."
David Sussman: Just to see how you respond.
Kari Bailey: There's no harm or foul, so if it doesn't work, it doesn't work. We're going back to where we started.
David Sussman: But you don't expect that patient who has retention to get better. And I think that's the patients for whom probably a stage one makes a little more sense. But I agree, PNEs are easy to do, and they're a quick way to understand how they're going to respond to more of a permanent implant.
Neil Kocher: Just a quick show of hands, how many out there are doing PNEs, basic tests? How many? Way up high. So what's that, 25%? How many want to do it? How many if you, I don't know, were taught, is anyone interested in integrating it in their practice?
David Sussman: I think it's—
Kari Bailey: Hey, got one.
Neil Kocher: These are huge.
David Sussman: It's not difficult to do. And I think really it is a relatively simple technique, which I think has a lot of gains. And again, I think from a patient perspective, they're quite appreciative that you can do this quickly and in the office under local.
Kari Bailey: But it's all about how you bring it up.
David Sussman: Correct.
Kari Bailey: When you tell somebody, "It's an implant, we're going to have to implant something into your body," they're like, "Ugh." But if you're like, "Oh, we'll do a nerve test, and if it works, maybe this is a therapy that's going to work for you," I think it works well.
David Sussman: So who doesn't get neuromodulation? Obviously people that don't respond to stimulation, either a PNE or a stage one, people that are going to have some shortwave treatments of some sort. I think the other important thing is what's really changed with neuromodulation? Two things. The rechargeability, which I think has been, in my patient population, probably only one out of 10 people choose the recharge, but the ability to do MRIs has changed dramatically. So now you can use neuromodulation for patients with MS if you think it's appropriate, patients with Parkinson's. These are the patients that before this you would never use neuromodulation because they're getting MRIs on a regular basis. So those are typically Botox patients or other ways to treat them. Neuromodulation now has expanded its role because of the ability to get an MRI with these implantable devices, and that's changed things a lot. I think it's a huge improvement in our ability to deliver this care.
Kari Bailey: And even the non-rechargeable batteries now last 10 years.
David Sussman: They're 10-year batteries now, right.
Kari Bailey: So that's a huge difference.
Neil Kocher: Even better if you get the lead right, perfect, the nerve and not much juice.
David Sussman: Absolutely. And again, a lot of us learn this in residency, some obviously in fellowship, but this is the ability to do neuromodulation, as Neil will talk about, PTNS is incredible. Again, if not us, who? Yes.
Speaker 4: I didn't know that InterStim was approved for upper motor neuron disease such as Parkinson's and multiple sclerosis.
David Sussman: No, I'm sorry, I didn't mean to imply that. But you can use it for patients that have overactive bladder from a Parkinsonian perspective or MS, where you really couldn't before. These patients are getting MRIs on a regular basis. That was the reason.
Speaker 4: I didn't think that if a patient carried a diagnosis of MS, you could even do a PNE.
Neil Kocher: So to your point, a lot of these patients could have baseline overactive bladder urgency incontinence that then are subsequently diagnosed with, say, a neurogenic condition. And so in my practice at least, I will talk to them about that when they see me, whether or not they had that diagnosis or not, and I still can offer it to them. And there's success. In fellowship we did a study comparing PNE, which older studies said that compared to stage one, maybe not as successful. But if we looked at that and with current contemporary techniques, fluoroscopy, you can get success rates on that trial relatively close to a stage one. But patients with a neurogenic condition can have a slightly lower success rate.
Kari Bailey: And both companies are definitely still specifically with the MS population—
David Sussman: That's the biggest population.
Kari Bailey: ... we're working on that. They're working on that one.
David Sussman: But I think what we know now is though, if somebody has overactive bladder or detrusor overactivity, even as a result of an upper motor neuron lesion, you can still treat them with neuromodulation with some benefit. Again, may not be quite as good as maybe Botox or other modalities, but it used to be that anybody that carried a neurological diagnosis as the etiology of their overactive bladder or urge incontinence, you were not using neuromodulation because of the inability to obtain an MRI. And that was really the big issue. Obviously this is dependent upon you. I never did it with MS, and now I'm doing it more routinely with MS patients—
Kari Bailey: Same.
David Sussman: ... who have detrusor overactivity and urge incontinence because of the ability to have an MRI, which heretofore was not available.
Speaker 4: My concern is that many of us here have our own ASCs, and we're concerned that we're going to get reimbursed. I was part of the FDA trials in '96 on InterStim. And we didn't have much ... I'm a believer, but we just can't get approval for it.
David Sussman: That I couldn't speak to. You're right, that's a different issue.
Kari Bailey: And some insurers, regardless of the guidelines, are going to still say behavioral modifications, two medications. So there are still certain conditions even that are approved for that we're not going to get covered. So it's a lot to consider.
David Sussman: Listen, I think even with the new guidelines, we're still at the mercy of insurance companies and what they allow us to do and not do. But it's a good point. I haven't had any pushback yet on MS patients. I've only done one Parkinson's patient, and I didn't have a problem, but it's a good point. I thank you. Appreciate that. So again, who else? Not a good idea for neuromodulation: pregnancy, pediatric, etc. Anyone doing bilateral stimulations here routinely or sending people home with bilateral implants with batteries on both sides? There are some people in our world that do them routinely. I haven't found them to be effective or more effective than that.
Neil Kocher: Limited data.
David Sussman: There's not a whole lot of data about that. And who's a good candidate? Again, we know this: failed medical therapy, although today maybe not so much, fairly compliant, willing to follow up and work with us and be willing to go through the adjustments and programming changes that go through it. But again, I think the other thing to keep in mind is fecal incontinence, which I think has shown fairly good results in the population of patients who have non-obstructive retention—
Kari Bailey: I'll say insurance-wise for fecal incontinence, you don't have to jump through as many hoops.
David Sussman: That's true.
Kari Bailey: If they have fecal incontinence, it doesn't matter if they've failed any medications from whatever insurer, it's first-line treatment. So they'll go straight for that.
David Sussman: So again, I think with this change in the guidelines and the fact that we now, I think, continue to have some expansion in our ability to treat, as Neil will talk about, with PTNS and some of the changes in neuromodulation, I think it's going to expand our ability to help these patients. And of course, Botox when appropriate. And by the way, there's nothing wrong with multimodal therapy, just like hypertension. But have those discussions. I have patients typically from Dr. Brown who need neuromodulation, Botox, and meds, and some people require that combination to really achieve the goals they're looking for. So I think all of these things are part and parcel of what we can deliver in the stage of overactive bladder. And again, people who are not good candidates: obviously people who may not respond well to either a PNE or stage one, some sensory deficits, pelvic pain, significant comorbidities, again, neurogenic bladders. We talked about maybe your role obviously with the ability to do—
Kari Bailey: I think that just bridges to the next therapy is that poor surgical candidates. So you have a patient who can't go to the operating room or doesn't want to go to the operating room, Neil's going to talk a little bit about some PTNS, and we all know PTNS, but ITNS, and tell us a little bit about that.
Neil Kocher: A new thing.
David Sussman: You're up.
Neil Kocher: All right, so let's move a little forward here.
David Sussman: I think I had some ROSETTA data for you, but we can go through that.
Neil Kocher: All right, so hopefully everyone's familiar with percutaneous tibial nerve stimulation, been around the block for quite some time. The hot new kid on the street is the implantable devices. So this ITNS therapy, so novel therapy used for urgency incontinence, OAB. It's minimally invasive. I do them under local. These are implantable devices. They offer an at-home therapy. So for folks who are coming from long distance or can't spend 30 minutes or more every week in the office, this can be with or without, say, the patient being involved. So certain devices out there, and there's a lot more coming out, have where a patient can adjust or not. Currently, two are on the market, but again, there are many more on the horizon. And the whole idea is to optimize this, to decrease that patient burden, to get their therapy and overall improve quality of life.
So one device, the first to come out was this eCoin, and here are the data that were published several years ago. And at one year, we had 70% with greater than 50% improvement. That's that cutoff we use to document success. 20%, a little over, were dry, just relative data that Botox, the OnabotulinumtoxinA, that's about 40%, give or take, based on those data. So that's pretty good. And again, this takes 20 minutes to do, and 90% were satisfied, would recommend. There's a little bit of some data that was affected by, of course, the pandemic. It was not blinded, and there was a 3% explant rate.
Next one on the market looks like a little, I don't know, house arrest monitor, this Revi device. But ultimately at one year, again, 82% showed a 50% improvement. These data are quite good though. 50% dry, 95% satisfaction, high compliance. But again, similar unblinded and 4% device-related.
David Sussman: I think one of the differences between eCoin and the Revi, the eCoin sits above the fascia, and the Revi sits below the fascia. It sits right on top of the nerve. And this is just my opinion, I think it's going to be ultimately, I think that may be one of the reasons for the better results.
Neil Kocher: It's possible, yeah.
David Sussman: I just think that to me—
Neil Kocher: It's so new.
David Sussman: It's so new. We don't know.
Kari Bailey: And battery life.
Neil Kocher: Correct.
David Sussman: And battery life.
Kari Bailey: But that'll happen.
David Sussman: eCoin has a relatively short battery life.
Neil Kocher: They say about—
Kari Bailey: Three.
Neil Kocher: ... five years or so, if you can get it pretty low. So I just have a quick video. This is in my surgery center doing the first device, that eCoin. So you basically mark it using their little template. And patient's awake, clean the skin, numb them up with a little local, prep really well, go from proximal to distal, really getting the area that you're working on. The patient drove themselves and back, by the way, to get this procedure, which I thought was pretty interesting. So you can just cover the toes, a little sterile thing and just get your sterile field going. And then essentially once you're sterile, you just remark using another template, and then incise right over that incision, and to your point, going just down to the fascia, which we'll see in just a second here, but with tips up just dissecting that plane.
I think the surgery center was wondering what the heck a urologist was doing on the ankle. But here we are. So you can see the fascia there quite well. Very nice dissection. And then you use this little blunt dissector to go down towards that mark, that circle where I'm aiming to is where the device actually will go. They designed it such that the incision was away from where the implant will go, and you just go right to your finger without over-dissecting, just with some steady blunt pressure staying right on that fascia. Wash it out—the solution to pollution is dilution. And then essentially you can ... Well, every time I put an implant in, I don't know how y'all do it, I change my gloves, but putting that device right in that pocket and then seating it down into the area that was dissected. And then you close it up, and so you want to box it in, grabbing a little superficial fascia, grab a little of the soft tissue above, and then a multi-layer repair. That honestly takes more time than—
Kari Bailey: Takes the longest time.
Neil Kocher: ... actually doing—
Kari Bailey: For sure.
Neil Kocher: ... the rest of the case. But putting that together, running it closed, and ultimately a little glue and a dressing. So pretty quick procedure, easily approachable. You have to wear this very attractive compression sock for at least about five to seven days. And then typically we activate initially at a month, but now actually we're activating at two weeks. So that's it. Anybody here can do it.
David Sussman: Just a couple of quick thoughts about it. I think as urologists, Neil's right, we're not used to working on the leg or the ankle. These do pose some healing issues. And I will be honest, I think we have to be a little careful about who we choose. I live in southern New Jersey where the older folks' ankles are not the prettiest things in the world. So between peripheral vascular disease, venous insufficiency, and diabetic neuropathies, you have to pick and choose your patients carefully because they have to heal. And we're not used to managing or dealing with wounds of the ankle as urologists. So just a thought, I think you just want to be careful and choose patients somewhat cautiously.
Neil Kocher: They heal a lot slower.
David Sussman: They do.
Neil Kocher: The ankle incisions heal remarkably slower than, say, your incision for sacral neuromodulation or anywhere else in the body. So to your point, I have a patient of mine I saw a couple of days ago that even a month later, it still looks pretty fresh.
David Sussman: They tell you to elevate the leg for a couple days, stay home and elevate, which is sometimes difficult. So again, I think it's a great technology, but there are some pitfalls that everyone should be aware of. And I think, again, we're not orthopedic people. We're not used to this stuff. So I find myself looking at ankles a lot and thinking, nope. A lot of no's in my practice.
Neil Kocher: A physical exam really can—
David Sussman: Yeah, it makes a difference.
Neil Kocher: ... therapies.
David Sussman: It does.
Kari Bailey: Summertime's a little easier to come in.
Neil Kocher: Do you want your slides back up?
Kari Bailey: Yeah, we'll put the slides back up. But so now we set the stage for these therapies, and now we've changed the way in which we may talk to patients. So when you guys see a patient, do you talk about these right off the bat? Do you first—
Neil Kocher: Absolutely. Let's say you have someone who comes in, and let's say they have mixed incontinence, they're not sure which—a history is huge. You can pretty much figure out, for the most part, what minus maybe positional incontinence as we were discussing earlier. But definitely getting a good history, doing your physical exam, and then introducing everything. We have a printout, we have an algorithm, we have an OAB navigator that is available and has a centralized database on what patients and where they are in the pathway. But getting that idea of an implant or an advanced therapy right out of the gate, the next time they come and see you, it's a lot less radical. It's a lot less of a big wow factor.
And just another thing that I've figured out in my practice is having another implantable device relative to sacral neuromodulation has really changed patients' perspective on an implant itself, in that I'm getting a lot more either PNEs or sacral neuromodulation or, let's say, the implantable tibials, just because instead of it being Onabotulinum or a sacral neuromodulation and those, now you have 50%, two out of those of the four with PTNS are implantable devices. So it's really changed that patient psychology, consumer psychology, and getting a lot more implants because of it. So kind of interesting.
Kari Bailey: I like the education. I try to send them home with that OAB toolbox. Just so you tell them everything, they're inundated, they can't process it all the first time. But what I have found more now that I'm bringing the therapies up sooner, they come back more. So when they think the medication doesn't work, a lot of them were like, "Well, I didn't know there was anything else." So they are lost.
David Sussman: They tell a lot about evaluating practices and how we manage these patients. And if you don't let the patients know early on that you have a wide range of things to treat them, they often don't come back. Especially if they've had a med already and they failed and you don't give them that story, I think they quickly lose faith that we're going to be able to manage them. So I think the earlier you discuss these third-line therapies, which they may change the name now from third-line to just additional therapies—
Kari Bailey: Therapies, yeah.
David Sussman: I think it benefits the patients because they understand that we can help them in almost every case, whether they respond to medications or not.
Neil Kocher: Another quick point, I don't know how many of those in the audience are aware of, but anticholinergics are really linked with increased risk of dementia. And of course, they stratify, being the highest risk, maybe your trospium and others are a little bit less risk. But if patients are finding this information online, then you need to counsel them on that. I think the AUA update that just dropped quoted up to a 20% increased risk with just three months or more exposure. That's mind-blowing. That is insane. So patients are finding this data, and certainly you need to counsel them. And I think that's going to shift towards advanced therapies, especially with insurance coverage being an issue or side effect profiles or what have you. So learning these and being comfortable with these, I think, is really important.
Kari Bailey: And that was what I was going to bring up is a lot of these patients will come and see you. They've been on medication, they've been on Botox. So how do you bring that up to patients, or how do you get them back in the fold? I feel like some of these patients are six months post-Botox. How do you get them back in to discuss this stuff? How do you do that?
David Sussman: Listen, I think it used to be that you'd give somebody Botox, you'd say, "Let us know when it wears off." I never do that. I think we need to see those patients and understand and see them in four or five months. I tell the patients the average Botox is six to eight months, some are longer, some are shorter. I think if you see these patients on a somewhat regular basis, you understand their journey, you get a better sense of when the medications wear off so you can get them the next Botox injection. Same thing with neuromodulation. If you've done an implant and they're doing pretty well, I do see them every six months just to get a sense of where they are.
And my first question is, have we achieved your goals? Are you where you want to be? Have we done enough for you to get you where you want to be? Because sometimes it's going to be making adjustments in the program, adding Botox or adding a medication on top of where they are. So I think it's a constant process. We didn't have much to offer before. You didn't ask them any questions because you didn't have many answers. Now we have a lot of answers, and I think the questions are appropriate. And I think, to Neil's point about anticholinergics, besides the issues with cognition, we need to be concerned about the side effects. Most of my patients are constipated at baseline. I think to add to their constipation is a crime for a lot of these patients to make it right.
Neil Kocher: It's only going to make their OAB worse.
Kari Bailey: And then the dry mouth, they're drinking all the time.
David Sussman: The dry mouth as well, right. So I think these are all things that we need to be cognizant of. And as we counsel our patients, we're the experts. We understand what roles these therapies play. Try to help them make good decisions. Well, the issue, we talked about what's refractory, but I think refractory is when you can't afford the medication, and I think that makes it a refractory issue. I really believe that just because it works, they can't afford it—what's the... Peter?
Speaker 4: I was just going to ask if you could comment on the evaluation of a male OAB patient and do without the quantitative approach.
David Sussman: It's a great point. I think we shouldn't forget that we see a lot of men who have overactive bladder. And again, we all know this story that physiologically a lot of men develop OAB as a result of obstruction. Their bladders become less elastic. We know that story, that a lot of men see it as a result of their obstructive symptoms from their prostate. We also know that there are some men who develop OAB independent of their obstruction. And I think that's a discussion that not a lot of us have but should have because I think it's important to let men know where their symptoms are coming from.
And we also know that if you treat their outlet, sometimes their OAB gets better. Not always. And we can't predict that. Whether you do a UroLift, a Rezum, a TURP, we all know that OAB doesn't always get better as a result. So I prepare those guys with that discussion. But I think you're right, Peter. I think a lot of men have OAB, a lot of the post-RP men who come in with incontinence, we talk to the residents about this all the time, a lot of them have DI because they've had a change in the nerves to the bladder after an RP. And oftentimes you do urodynamics in those men, they're not—
Kari Bailey: That's what I was going to ask you. Do you change your evaluation a little bit from men in terms of more urodynamics or UroCuff or whatever? Do you tend to?
David Sussman: I do.
Neil Kocher: I think so.
David Sussman: Because I think the discussion's often going to be you have an outlet obstruction, and you have OAB, two different issues. Now how are we going to deal with this? How are we going to approach this? And the order in which we approach it, I usually tell men that treating their outlet effectively will then help me treat their OAB more effectively.
Neil Kocher: That can be a tough sell too, because patients come in with urgency, nocturia, all of the classic bladder outlet obstruction. They're like, "I think my flow's fine." And you do objective studies, and you're like, "Dude, it's terrible. I don't know what you're thinking." And then they go, and they get a procedure and may, again, not improve their OAB. So it's definitely a challenge, it's a balance, but you can definitely treat the OAB at the same time. But addressing that outlet is important.
Kari Bailey: I find UroCuff is kind of nice.
Neil Kocher: Very nice.
Kari Bailey: Because they don't have to do it through the urodynamics testing. It is a really quick procedure just to say, even sometimes for the insurance companies, it's not obstructive.
Neil Kocher: And there are newer devices coming out that are ambulatory urodynamics. So there are going to be new commercialized devices where they'll eventually go home with that, and you get a little bit more of a finer granular data on whether they're obstructed or not because urodynamics isn't perfect. We know that.
David Sussman: I think we underutilize urodynamics in men personally. I think that there's a lot of men who probably would benefit from urodynamics that we don't do, yet we have a tendency to order it on women very easily. I think that's a little bit of an issue that we all need to address. And there are men, I think, again, who have complicated voiding issues. Certainly the previous surgeries, whether it's RPs or other kinds of pelvic surgery or just the obstructed guy, but whose symptoms are more OAB than they are obstructive in nature.
And I think UroCuffs have a role in the more index patient, urodynamics in a little more complicated patient. I think we all have gotten around to doing more TRUSes and cystos as part of that evaluation, as the AUA guidelines have changed for BPH. So I think we're doing a much better job overall as the guidelines have given us the imprimatur to say, "You know what? We do need a TRUS and a cysto and maybe urodynamics for that patient."
Neil Kocher: And the therapies just keep getting better, right?
David Sussman: They do, absolutely.
Neil Kocher: So improved meds, improved advanced therapies, at-home availability. So the future's very bright for OAB management.
Kari Bailey: So we lost our slides, but the take-home points from this talk that we were hoping to get across were that it's no longer third-line therapy. So thinking about it in a different way, shifting the way in which we talk to patients. There have been many advancements in the field in terms of making the devices better. I think a lot of people trained in an era where sacral neuromodulation was not as good as it is today and maybe have a little bit of a misconception as to how effective it is. And I think that's something really important I have found with some of my partners. And just having a point person, bringing people through the thing. And then really we're underutilizing this technology. We're underutilizing treatments that help patients, so we need to do better.
Speaker 5: Do you have a navigation system within your practices to try to help identify these patients prospectively? Because obviously you guys do this at a very high level, but not everybody over a wide geographic area or over a large practice can do it as well as you do. So how do they get to you other than just referral? What does that process look like in terms of—
Kari Bailey: So for my group, we've brought into a chronic care management program. So I try to sign my patients, specifically OAB patients, up for the chronic care management program, so that they can move through these therapies and not get lost to follow-up in that way. It's reimbursed, so we're able to have staff that are able to check in with these patients. I think a lot of programs have a nurse navigator, but again, you have to be able to... And listen, if you have a nurse navigator who gets these patients in the door, you're going to cover the cost of having that person in your group. So I think that, head and shoulders, absolutely. But for us, we use that chronic care management program a bit. How do you guys do this?
Neil Kocher: Nurse navigator, yeah.
Kari Bailey: Nurse navigator.
Neil Kocher: And really I think, as you mentioned, having scheduled follow-ups. I'll see my Botox patients, and I'll be like, "All right, see you next season. Spin the wheel on your Botox, see when it wears off."
David Sussman: I think you're right.
Neil Kocher: Every injection is a little different, but they'll get a feel for it too.
Kari Bailey: But I also use the chronic care management, and I send them a message, "Hey, check in with this person in five months. Find out where they are. Hey, and while you're at it, let them know there's another therapy that if they want to discuss it with me, come back in."
Neil Kocher: Plant that seed.
Speaker 5: Lastly, you had alluded to, I think David had mentioned, the ROSETTA data, which really is looking at comparison of—I think this is not really my field—but Botox to sacral neuromodulation, correct? Could you help us understand that data and what that looks like just briefly before our time ends here?
David Sussman: So ROSETTA was an interesting trial. It looked at neuromodulation versus—unfortunately, they used 200 units of Botox, which is not the standard dose. So the ROSETTA trial is a little hard to interpret. It looked a little better on the Botox side, but again, I think they used 200 across the board.
Neil Kocher: Non-neurogenic.
David Sussman: Right, non-neurogenic indications. So I think the data was a bit skewed, but I put it out there just to remind us that look, these therapies have been around a long time, and we're constantly looking at one versus the other. Sometimes they're complementary, quite frankly. And I think I can just tell you in my practice, and I think my colleagues will agree, when you start to get a sense of what people are interested in, some people you say the idea of Botox, and they're like, "No, I don't want to be injected every six or eight months." Others, the idea of an implantation makes them crazy. So I think you have to get a sense of what works for the patient, but I do also recommend that we tell patients it's multimodal therapy and they need it because their symptoms are so problematic that they need to be more than just one.
Neil Kocher: There's a synergism.
Kari Bailey: And that's what I like to talk to patients about too. When they get overwhelmed, we're not tied to this. If you do a PNE and it doesn't work well for you and you decide not to do it, it's fine.
Neil Kocher: They're all good options.
Kari Bailey: Botox, when your Botox wears off, we can do sacral neuromodulation. So I think it's a lot of good therapies out there.