“This is a lifetime disease; you want to make sure that the battery not just has long enough life but still has the capacity,” says Colin Goudelocke, MD.
In this video, Colin Goudelocke, MD, describes the background behind the Neurourology and Urodynamics study, “Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6-month results from the global postmarket ELITE study.” Goudelocke is a urologist with Ochsner Health Center in New Orleans, Louisiana.
Sacral neuromodulation is a modality that's been around for over 25 years. During that time, we've always used what I'll refer to as primary cell battery technology, which is for most of us what we think of as batteries: You start off with this certain amount of energy, and over time, that energy starts to run down. When the battery's dead, you change it out. But we also have cell phones, and we know that when the battery in your cell phone dies, you don't just throw it out. So it seems logical, then, that that idea of rechargeable technology should come to sacral neuromodulation. I think it's really important. Anytime I talk to patients, one of the things that I always emphasize is, this is a chronic, lifelong disease that we don't have a cure for. So anytime we're talking about treatments, we're really talking about what treatments are going to be best for you, what treatments are going to be most tolerable for you over a long period of time. So if it's medication, are you comfortable taking medication every day? If it's sacral neuromodulation, we need to think about how is this device going to perform over your lifetime. That's where this idea of rechargeable sacral neuromodulation devices are introduced, so rather than having a battery that might last 5, 6, or 7 years, and then have to be changed, can we have a battery that can be recharged? And so that's what the Micro is; it is a rechargeable device where a patient will use it and approximately every 2 weeks, they'll apply an external recharger that can then charge that battery up, and then they'll use it over the next 2 weeks. There are some advantages to that. One is size. When you have a rechargeable battery, it doesn't have to be nearly as large as the primary cell battery. The idea has always been, the smaller the primary cell battery, the less time that you have, the shorter that duration is. With a rechargeable, you don't really have to worry about that; you really only need a battery that's going to last for 2 weeks or 4 weeks before you recharge it again. The Micro is about 80% smaller than the predicate device, that kind of traditional device that we're typically used to. We all have cell phones, and we understand those batteries. But I know my iPhone is about a year and a half or 2 years old; I don't get nearly as long from a full charge as I did a year and a half ago. I'm not a battery chemist. Luckily, I have very smart people who explain all these things to me. There are concepts called cycle fade and calendar fade. Calendar fade means the older these lithium rechargeable lithium batteries are, the less life that they have. Cycle fade is what my iPhone not working so well because I've charged it so many times. But one of the really interesting things about the Micro device is that they use is what is called overdrive technology. Essentially, it's a battery that is resistant to that cycle fading, so that you can take it through cycle after cycle after cycle. And what you find is that capacity is nearly the same as it was at 5000 cycles as it was at the first cycle.Again, this is a lifetime disease; you want to make sure that the battery not just has long enough life but still has the capacity. All that goes into the idea of this micro device. But despite all of the studies and information and data that have been collected before these devices ever come to market, I think it's also really important that we look at some real-world applications. I do a lot of clinical trials where things are very, very scripted and very, very controlled and we're careful about the patients that come in, and we watch them very closely. I think the ELITE trial is more of a real-world application of these devices and following patients over time. Obviously, you have to qualify to have the device implanted in the traditional way and meet FDA-approved criteria for implantation, but beyond that, it's very much a real-world trial to see how these devices perform in patients over a 2-year period. This is a post-marketing global study of patients. We're following patients with overactive bladder, patients with non-obstructive urinary retention, and patients with fecal incontinence. We're looking at them over a 2-year period. This particular presentation that we did recently was the 6-month update on that, but we will follow these patients out to 2 years.
This transcription was edited for clarity.