![]() In terms of surprising results, I don't think there's anything in the trial data that's really surprising to me. And that perception of migrating expectations may not be true for this device. Almost 90% of these patients still feel like their symptoms are improved 6 months into this. And, frankly, we see at 6 months that the satisfaction rates, the quality-of-life indicators, those sorts of things, appear to be maintained. So the other thing I think was really important is to look at how patients do over time. But maybe it's 6 months later, now I'm starting to get aggravated by the fact that I'm still leaking twice a day. And that certainly is a huge improvement. Now I'm leaking twice a day, and I perceive that as this huge improvement. So when I had this device first put in, I had been leaking 6 times a day. One of the arguments why people like me perceived the possibility of decreasing efficacy over time, is that maybe patients' perceptions of their improvement are migrating or changing. Patients have the same objective improvement at 6 months that they had at 3 months. For people like me that do a lot of these, there's always been a little bit of a sense that maybe we've seen some fall-off in the efficacy of neuromodulation over time, but at 6 months, that doesn't seem to be the issue here. What I really want to see is do we see that improvement maintained at 2 years. What's really encouraging to me is that the improvement that we see at 3 months is maintained at 6 months. The frequency of voids went from about 4.5 fewer voids per day at 3 months, and then at 3 months, it's 4.4 fewer voids per day. At 6 months, that held up it's 3.7 incontinence episodes. At 3 months, on average, we saw a reduction of about 3.6 incontinence episodes per 24 hours. But we do see that the device appears to be clinically efficacious. This is an intermediate snapshot at how this device is performing obviously, we want to watch that and see if that holds up over 2 years. ![]() The other thing that is important in a study like this is to make sure that not only we have clinical efficacy, but that we have clinical efficacy over time. And it does appear to be, at least at 6 months, but we'll continue to follow these patients up to 2 years so that we can make sure. But first, we want to make sure that it is as safe as the device that we've been using for 25 years. And there's certainly some advantages to it. Remember, we're comparing this new device to what we've been doing for 25 years. And that really tracks with what we see in the primary cell data. That resolved with a surgical revision of the device. There was 1 patient who had some pain at the site of the device. There was 1 what we classify as a serious adverse device event, which means anytime there's any kind of significant intervention. At 6 months, we didn't have any unanticipated adverse device events. And certainly not surprising, but maybe reassuring more than anything was that the device was safe. The aim of this study was to look at the safety and the clinical efficacy of the device. In this video, Colin Goudelocke, MD, shares notable findings from 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.
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