Dr. Goudelocke discusses Vivally System for overactive bladder

Colin Goudelocke, MD

In this article, Colin Goudelocke, MD, discusses the 2024 Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting abstract NM019: A prospective sham-controlled safety and efficacy trial of a wearable transcutaneous tibial neuromodulation system treating overactive bladder syndrome (REDUCEOAB). Goudelocke is a urologist with Ochsner Health Center in New Orleans, Louisiana.

[This study] evaluated the Vivally System, from Avation Medical. This was their third clinical trial. They had initially done a feasibility trial that I wasn't involved in, then they did a second trial called the FREEOAB trial. Those data were just published in Urology recently. That was their second trial, without a randomized arm. Essentially, it was being compared to itself; it was 3 times a week vs 1 time a week.

The abstract that I presented this time around was the result of their third trial, which was their pivotal trial, the data they submitted to FDA for approval, and it was called the REDUCEOAB trial. It's a prospective, multicenter, randomized, sham-controlled trial, in which the sham arm had everything the same about the device, other than it just wasn't turned on. Essentially, to me, it looks kind of like an ankle brace. They call it a garment. But it's a neoprene sleeve that is Velcro-ed across the foot and Velcro-ed across the ankle. That essentially secures little gel pads right over the posterior tibial nerve.

The other thing that it has built into it is an EMG. If you think about sort of traditional posterior tibial neuromodulation in the office, the patient comes in, we put a needle where we think that posterior tibial nerve will be, and then we stimulate it and we look for that foot movement. There are 2 reasons why patients had to come into the office for that. Number 1, they had to have us stick a needle in their foot each time, and number 2, they had to have someone who was there capable of interpreting that we're actually stimulating the right nerve. So the way these guys got around that was first of all, to have a gel pad we can stimulate it transcutaneously. They've used TENS units sort of off label in Europe for that before. And there have actually been quite a lot of papers written about that. There is a US device that was FDA approved slightly before this one that is similar; it stimulates transcutaneously kind of like a TENS unit, but it doesn't have this built-in EMG.

I think the interesting thing about the EMG is they're actually able to capture evidence that they stimulated the nerve. They can tell when we've reached the amplitude of stimulation that stimulates the posterior tibial nerve. We collect that data through the EMG, and so it truly is a home-based therapy. A patient can essentially put it on, it connects wirelessly to an app on their cell phone, and then the app sort of takes over. It can adjust the stimulation to make sure it's getting that appropriate response. In this era, as you look through the SUFU abstracts and AUA [American Urological Association] abstracts, all anyone is talking about right now is tibial neuromodulation. But of course, that's implantable tibial neuromodulation, whereas these guys have really presented a very different option. I think that does a couple of things. Number 1, it makes it very interesting to see where would transcutaneous tibial fall? We normally think about overactive bladder in terms of our SUFU/AUA guidelines, first-line therapy being behavioral therapy, second-line therapy being pharmacologic therapy, and third-line therapy being things like [onabotulinumtoxinA], sacral neuromodulation, and traditional percutaneous tibial neuromodulation. And I imagine that implantable tibial would probably fall somewhere on the same threshold potentially as sacral neuromodulation and Botox and posterior tibial because it's invasive. But with a noninvasive, home-based therapy, when would you use it? Certainly, you're going to try more conservative therapies like behavioral therapy first. But would you do it before medication? It may end up being cost effective as compared with medication; it's certainly going to have fewer side effects than medication. So is this a second-line therapy? Is it a third-line therapy? Probably not. I've even thought of it as sort of a "1A" therapy. We actually had drug-naive patients that were included in the REDUCEOAB trial. For me, I always thought about it in the same way that I thought about traditional PTNM, where patients are coming in the office and having a needle put in their foot. But the first patient I enrolled in the REDUCEOAB trial was actually a 25-year-old woman who just didn't want to take medications. And when I gave her the option of, well, we could try this thing that you put on your foot for 30 minutes 3 times a week, or you could take a medication every day, I was a little surprised, but she said, "No, I'd much rather put something on my foot for 30 minutes 3 times a week than take a medication." It took me aback a little bit, but really opened my eyes to where this therapy might fall. That's the background behind it.

I'm working on the paper for it right now. Our sham group did remarkably well. Now, the treatment arm did statistically significantly better, so we know the device works. But the sham group actually did pretty well; I think it was a 53% response, which is really high for the sham arm. One of the interesting things is that this company also developed a really nice companion app that asks patients questions like, how much caffeine do you drink and how much fluids you drink? And to really make it fair, so that we could tell differences between the app and the device itself, we actually included patients who were in the sham arm got the app as well. The thought is probably that that's a lot of behavioral therapy; when you ask patients about how many caffeinated beverages a day they drink, they're going to start putting 2 and 2 together and say, "Well, maybe I shouldn't drink so many caffeinated beverages." And so we think that there are some behavioral therapy aspects to it, and that's probably why the sham arm did so well. But overall, the therapy response rate was actually pretty good. Everybody got better, both in the sham arm as well as the treatment arm; it's just patients in the treatment arm got "more better," as it were.

It is FDA approved. They're still working with CMS. One of the issues is that we don't yet have a code that we can use, so you can imagine that presents some challenges to getting insurance coverage. I'm not involved in anything along those lines; I just participated in the clinical trial. But they tell me that they are working feverishly with CMS to try to get Medicare coverage, and then working with a lot of the independent payers. I think some of the payers look at this and think, "wow, it's a 1-time payment for a device vs paying for medication all the time, or even some of the implantable devices." It may look kind of attractive to some of the payers, but I did want to be real clear that it is an FDA-approved device; I could write a prescription for it today. But they are still working through the process of getting more generalized insurance coverage.