Opinion
Video
Author(s):
"[The lack of] a battery makes it ultra small. That's really important," says Colin Goudelocke, MD.
In this video, Colin Goudelocke, MD, describes the advantages of a batteryless neurostimulator evaluated in the study “Treatment of OAB symptoms using Neuspera’s ultra-miniaturized system: 6-month results of the SANS-UUI phase II study,” which was presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction 2025 Winter Meeting. Goudelocke is a urologist with Ochsner Health Center in Covington, Louisiana.
This is an ultra-small device. It's the smallest, I think. You can imagine if you're subtracting out the largest part of the device, it's not surprising that it's smaller. [The lack of] a battery makes it ultra small. That's really important. As someone who really believes in sacral neuromodulation therapy, I don't want to lead people astray. Most patients are very happy with traditional sacral neuromodulation. But there are issues, there are problems, and for that subset of the population, most of the issues that we do see with neuromodulation, frankly, they're usually with the generator. Most infections that I see are generator site infections. Most of the pain that patients experience is at the side of the generator. A lot of times we have movement; we sometimes call it "twiddler syndrome," where people will tend to, if the pocket is a little bit bigger than the battery, they can actually twist that battery around. They kind of twiddle with it. I think that that term was actually coined in people doing the same with their pacemakers, but it's true sometimes in sacral neuromodulation. Most of the issues that patients experience, frankly, they tend to be with the battery. So to the extent that this device might remove some of those issues, that's really going to be impactful.
Second, it's kind of interesting, because in 1 approach to sacral neuromodulation, some devices have sort of taken an approach where we really want to sort of remove the patient as much as possible, sort of almost the "set it and forget it" version of this. Can we make it as hands off for the patient as possible? Because it's an externally driven device, and because the patient is actually applying it to their skin, on average, for about 2 hours per day, the patients are really involved in the therapy. I don't see that as a bug. I actually see that as a benefit. Patients are actually in control of their therapy. They're actually, in their mind—and I think there's some reality this—they're administering their therapy every day. I think there are some advantages to that patient control, to a patient actually being able to direct her therapy or to direct his therapy. That may actually be borne out by the data. This is interesting, and I think this is a little bit of speculation on my part, but as I said before, this therapy, I think, looks really good in compare comparison to other sacral neuromodulation trials. We saw about an 84% response rate. For me, that's sort of what I would expect from a clinical trial of a sacral neuromodulator. Of those respondents, so of that 84%, 84% are what they are characterizing as "super responders," meaning they had at least 75% improvement.Most of our clinical trials, we define a 50% improvement in symptoms. They're giving this this new category of 75% improvement as super responders. And the 84% is a really high number. Furthermore, 42% of patients were dry. This is very interesting. I enrolled patients in this clinical trial. I didn't have any access, obviously, to all of the data. I just knew, until this was published, I just knew my patients. But I kept noticing, and in fact, in my conversations with the people that were running the trial, I kept noting, I said, it's really interesting. I have some patients who have responded, I have some patients who haven't responded. And again, my response rates in my own patients that I implanted seemed pretty in line with this, but I kept noticing that the patients that are getting better seem to me like they're getting a lot better. The ones who didn't respond didn't respond, and I understand that, but the ones who were responding were really, really better, way better than 50%. I kept making the comment, "I'll be really interested to see when these data come out, whether or not that's the experience across the entire group," and that seems to be the case here. Purely speculative, but I'm really kind of curious. Is it something about that? Is there something about the patient having control over her therapy, the patient being able to feel like "I'm doing this to myself, and I'm getting better, and I'm feeling this stimulation." I think it's a really interesting question. This study is in no way meant to answer that kind of question. But I think it's really, really intriguing that in a study where patients have all of this control, we have this higher rate of "super responders," which I think is really interesting.
This transcript was AI generated and edited by human editors for clarity.