“We might find that there's a certain type of patient that really thrives on interacting with the device and playing an active role in his or her therapy,” says Colin Goudelocke, MD.
In this video, Colin Goudelocke, MD, describes next steps following 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.
There are a couple of aspects to that. The first is that the data that we presented here at 6 months was the data just on patients with overactive bladder and urgency incontinence. There are a lot more of those patients than the other indications; that was the arm of the study that was the quickest to enroll, and so naturally, that's the arm of the study that we get the earliest 6-month snapshot, 1-year snapshot, 2-year snapshot. We want to continue to follow these patients, and really work to make sure that we keep these patients in the trial, so that we have data on them for 2 years. Because that's the other thing: As I talked about, the primary cell devices have started to improve a lot. The main advantage that these micro devices have is their size. So how does that affect patient satisfaction and use and those sorts of things over time? Those are really important things to look at over that 2-year time period. If I'm a physician, and I'm talking to a patient, and he or she is trying to choose between a rechargeable device and a nonrechargeable device, what information can a study like ELITE provide, so I can give him or her better information and say, "This certain type of patient really seems to do well with a smaller device."
There's also the aspect of rechargeability. Every couple of weeks, the patient is going to have to interact with the device. We sometimes think about that as a bad thing. But it might actually be a good thing; we might find that there's a certain type of patient that really thrives on interacting with the device and playing an active role in his or her therapy. If we can start to tease out those subsets of patients that do better with the size and do better with the interactivity and the involvement in their own therapy, maybe I can give better advice to my patients a year and a half from now, when they're trying to decide between one device or the other. The other thing is that again, since this snapshot is really of overactive bladder and urgency incontinence, it'll be really important to get more data on those patients with fecal incontinence or nonobstructive urinary retention, because we may find out that they act very differently. Maybe a patient with fecal incontinence or urinary retention behaves very differently over time. So we'll want to see what those data can tell us as well.
This transcription was edited for clarity.