Jason Kim: Good morning. Thank you for the introduction. Today I'll be talking about the Glean™ Ambulatory Urodynamics system. The Glean™ Ambulatory Urodynamics system has several components. It has a disposable bladder sensor, which is placed into the bladder during the duration of the test, it has a Bluetooth-enabled uroflow, and a software package. And so, what happens during the test is a bladder sensor is placed into the bladder, we will have a animation of how that's done, and there's a uroflow meter. So, during the duration of the test, the patient has a few natural filling and voiding cycles. The patient is asked to at some point to perform a pressure-flow analysis. This data is stored on the uroflow in the bladder sensor. At the end of the test, the bladder sensor is removed and the data is downloaded to the clinician app along with the uroflow data. The patient also has an app on their phone, and they can denote different events such as leakage and urinary voiding, and this is synced into the Glean™ web app. And this data is all correlated together and we get a very nice tracing on the web portal.
Here's a quick animation of how the device is deployed. So first, the device is synced to the iPad. It's backloaded into a sheath. Looks like a coude catheter. It is placed into the patient's bladder, much like a coude catheter, and the pusher is used to advance the device into the bladder. There are two different sizes. There's a male size which has a longer sheath, and a female size which has a shorter sheath. There's a string on the end of the device. At the end of the test, the device is removed much like a stent on a string.
So basically, we know that a conventional urodynamic setup takes a dedicated room, staff, a large amount of equipment, expensive equipment, and now this can all be accomplished by a device that fits in the palm of your hand, so I do think this will be a game-changing device. If we look at conventional urodynamics versus Glean™, it's really a paradigm shift. So we talked a little bit about the setting. The urodynamics requires a dedicated suite and specialized equipment, and often for many practices, this is not feasible, or practices that have multiple satellite offices, it's not feasible to have a urodynamics setup in every office.
Well, with Glean™, this can be performed in any exam room by any trained clinician. The in-room time for conventional urodynamics is typically about 60 to 90 minutes, so there's a limited daily capacity. With Glean™, it is a much shorter time. It's about 20 to 30 minutes set up, and the patient can continue with normal activities. The patient experience, from our FDA trials, we found that the patients found the Glean™ system to be much more comfortable. It's been well established, with conventional urodynamics, there's a fair amount of patient anxiety, discomfort. This is an artificial environment. You're trying to urinate with catheters across the urethra and the rectum, and some studies have shown there's even a 36% voiding failure with conventional urodynamics.
Well, Glean™ Urodynamics, it's a catheter-free system. The patients are often sent home so they can void in a more natural environment. It improves voiding success. We did see in our trials that about 15% of patients who could not urinate during conventional urodynamics were able to urinate with Glean™, so this may change the diagnosis. The capital costs are significantly less with Glean™. A typical urodynamics system may be $50,000 to $80,000. The top-of-line systems are over $100,000, usually with a seven-to-eight-year lifespan, and in this day and age, a lot of hospital systems don't want to invest that kind of capital. The startup costs for Glean™ are a fraction of that. It's about $10,000 for two uroflow machines and 20 sensors. And moving forward, you just buy the disposable sensor, which is a few hundred dollars, and you don't need dedicated space for any of this.
And really, one of the biggest differences is the training burden. As we know, conventional urodynamics, it takes a long time to become competent in doing these tests, and it's hard to find qualified people to run these tests. In fact, we hear about a lot of offices where they have the equipment, but they can't find the staff to run the tests. It's different with Glean™an. Anyone who can put in a catheter can basically perform a Glean™ test, and there's really automated quality checks, so there's very little troubleshooting. I tell the story of my experienced urodynamics nurse who always goes on vacation for two weeks in the summer with her extended family, and for 10 years, urodynamics has stopped. Well, this year, on her first day of vacation, we brought in an LPN who had never done Glean™ before and she was able to perform four tests in that morning. So as you can see, this may be a game changer for staffing needs.
This is an example of a tracing. Basically, I'm showing two phases. If we look at the bottom left, this is the duration of the test, and it's approximately four hours long. On the top left and right are zoomed-in windows, and in each example, you can see a yellow box of what portion of the test is showing, so I'll concentrate on the top left. This is a six-minute window during the in-office phase. Once the device is deployed, we ask the patient to cough and Valsalva, and it's noted by a C and a V. And moving forward, if we see events like that, we can assume that to be cough and Valsalva.
We then ask the patient to perform a pressure-flow analysis. At the very top, we see the bladder pressure line, and we see the detrusor pressure rose about 120 centimeters of water. The green and blue represent the flow rate, and the voided volume in the green, we can see the flow peaked about 4 CCs per second and the volume was about 130 CCs voided. Based on this data alone, we can likely conclude that this male who has hesitancy and frequency likely has a bladder outlet obstruction from an enlarged prostate.
And just briefly on the right side, we see a zoomed-in window at the middle of the test for six minutes. This was a voiding phase denoted by the yellow V. The patient had entered that on their app, and we can see that bladder pressures rise again to about 120 centimeters of water. And although we don't have a flow rate here, we do see that that rise in bladder pressure looks a lot like the one during the pressure-flow analysis, so we can conclude that the bladder was generating pressure during this void.
So, what's coming down the pipeline for this system? Well, number one, everything I've shown you is a single-channel test, and a lot of clinicians have wondered if it's necessary to have a multi-channel test like traditional urodynamics. Well, I've been doing Glean™ for about the past year and I've been able to get the information I need from single channel. However, Bright Uro, the company making Glean™, has developed an abdominal sensor. It looks much like a rectal suppository. Again, it's on a string for removal, and it was actually FDA approved a couple of weeks ago. Should be commercially available in the next couple months. And now we have true multi-channel urodynamics. We do see in the future that there'll be integrated volume sensing, therefore onboard light sensors.
And to me, this is an exciting development also, because I think while we get urodynamics, we're also automating a bladder diary. I know a lot of clinicians complain about the quality of the bladder diaries that patients bring in. We see them filling them out in the waiting room, or the way they fill them out makes no sense. In the future, we also anticipate AI-assisted interpretation, much like an EKG, so now we put in the device and we can be given a diagnosis. I know there's some concern over the use of the current nomograms for conventional urodynamics, whether they're valid for the Glean™ system. However, with AI interpretation, I think that argument goes away when you're able to get a diagnosis. And in the future, we expect multi-day monitoring, so the device can be used for extended periods of time.
How has this affected the practice at Stony Brook? Well, we have nine sites, and prior to Glean™, we were only able to offer urodynamics at our two main sites, our main urology site and Women's Pelvic Health Center. And as you can see, we are geographically very spread out with our offices. A lot of them are satellite offices that could not accommodate a full urodynamic setup. However, since starting Glean™, we offer Glean™ at six sites now, so we've actually increased our capacity threefold, and this has led to decreased wait times for urodynamics, quicker time to surgery, and increased patient satisfaction, because they don't need to travel to these sites. It took some patients an hour and a half to get to these sites.
I think Glean™ represents a very exciting new technology for urodynamics, and I'm excited to see how it unfolds in the future. Thank you very much.
Alan Wein: That was great. I mean, remarkable, remarkable achievement, so let me ask you a few questions.
Jason Kim: Sure.
Alan Wein: How long did it take you to become familiar with how to actually read those tracings, since they're a little different from the conventional urodynamic tracings, and I'm sure that it takes a while to really get used to them.
Jason Kim: Right. I think what people struggle with in the beginning is the workflow and how to read the tracings. And quite frankly, looking at the conventional urodynamic tracings, it's so ingrained in us, we just kind of almost pattern recognition, right?
Alan Wein: Yeah, it is. Right.
Jason Kim: You have to understand, it's a little bit different. I mean, all the information is there. It took me maybe about 10 studies to really kind of understand the workflow on how to read a tracing in efficient manner. And at this point, it became almost like second nature. We're just so ingrained into the conventional tracings. It's a little bit different, but the learning curve is not steep.
Alan Wein: How long can you keep the catheter in place? I mean, it would seem to me that the longer you could keep the catheter in, the better off you would be in capturing what the person's micturition cycle was really like.
Jason Kim: Yes. With the current device, I believe the device shuts off after 24 hours, so once it's deployed, it has to be out and data downloaded within 24 hours. For some reason, if the data's not downloaded within 24 hours, it does not mean the data's lost, but it would have to be sent back to the company to retrieve the data.
That being said, I think this is one of the great things about ambulatory urodynamics. You'd be very flexible in what you do. You get that patient with isolated night events? I would put this in the afternoon and bring them back the next morning. A lot of times for presumed BPH, it's a very short test. After one voiding cycle, if they come with a full bladder, basically you want to know if they have pressure when they void. It could be a much shorter test, so I think that's the beauty of this. It could be tailored to the question that you ask. And so, some patients I do just in the office, and some patients, I actually send them home overnight with the device.
Alan Wein: Yeah. So, it seems like for the patient, and correct me if I'm wrong, but for the patient that has nocturia, that you could basically rule out involuntary bladder contractions as a cause. And so, you don't have to go through the trial of the antimuscarinics or beta-3 agonists. You can just assume that, hey, this is not involuntary bladder contractions, so those medications are not going to work.
Jason Kim: Yes. Well, exactly. The thing is, with isolated night events, we've never been able to capture data on it, so this is, I think, one of the most promising aspects of the device.
Alan Wein: The last question, I did hear a little bit about the rectal sensor. How big is the rectal sensor? I didn't actually get a chance to look at it, but-
Jason Kim: Yeah, so it looks almost like a big rectal suppository and it's on a string. And most likely, how most people would use it, I envision in the beginning, is much like I showed you the tracing of the in-office portion where we denote events. Probably leave it in during that phase to kind of get a baseline of what's going on. I'm not sure people will send them home with a rectal sensor, but I could be wrong. We haven't deployed it in clinical practice yet.
Alan Wein: And the rectal sensors are disposable as well?
Jason Kim: Yes, they are disposable, and people also ask the question, in some women we put the abdominal pressure in the vagina.
Alan Wein: In the vagina, yeah.
Jason Kim: It has not been studied yet, but I'm sure that's something they'll probably look into in the future.
Alan Wein: Yeah. I mean, with regular urodynamics, I've not done it, but for pressure-flow studies with abdominal pressure, I mean, I read all the time that vaginal pressures are pretty much equivalent to the pressures you record transrectally.
Jason Kim: Right. It just hasn't been looked at yet.
Alan Wein: Yeah. Well, it's an exciting development. It's something new, and I think that a lot of people are going to become attached to this because of the convenience of use. Now, just one more question that occurred. Can the patients take a uroflow home with them? So if they have a voiding event at home, they can record it, or not?
Jason Kim: Not at current time. This is a Bluetooth-enabled device. I think it's something they are investigating and something they're considering. I think they do have things in development for possible uroflows at home. The other thing is, in the future, it may be possible for AI assistance with volume sensing, it may be able to determine the uroflow. This is an exciting time with artificial intelligence. We don't know what's completely possible with it.
Alan Wein: So this morning, Grand Rounds at the University of Miami was on artificial intelligence. Dipen Parekh gave a great talk about it, and it would seem to me that this is the perfect application, especially artificial intelligence is going to be able to interpret these records perfectly, just like radiology, pathology, et cetera. So, I think in the future, five years maybe, that urodynamics are going to be totally different. Well, listen, thank you so much. I'm sure that everybody who watches this is just going to say, "Wow."
Jason Kim: Yup. I certainly did when I heard about the device. Thank you, Dr. Wein.