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Diane Newman: Welcome. I'm Diane Newman. I'm an adult nurse practitioner at the University of Pennsylvania. I'm also adjunct professor of urology surgery. And I'm really excited because my guest today is a colleague of mine, Dr. Howard Goldman, and the renowned urologist of the Cleveland Clinic whose expertise is in pelvic floor disorders urology. So tell us a little bit.

Howard Goldman: So I'm at the Cleveland Clinic in the Glickman Urologic Institute and I'm a professor and vice chairman of that department. And as Diane mentioned, my areas of interest are in public floor disorders, bladder physiology, neuro-urology, urodynamics, and female reconstructive surgery.

Diane Newman: You're also involved in the International Climate Society, correct?

Howard Goldman: I am. I'm the head of the education committee and I wear a number of other hats as well.

Diane Newman: Well, today what I'd like to talk about because we're at the American Urologic Association, is your research on the Uromonitor, which is a non-invasive kind of a urodynamic device. Tell us a little bit about this.

Howard Goldman: Yes. So the whole idea, and this is based on research, a lot of it came out of the lab of Margot Damaser. I was sort of the clinical side of it, but her and her team are the ones who really came up with it. The idea is that the standard urodynamics as we practice it in the United States and around the world currently involves a lab setting with a lot of catheters put in the patient. And the truth of the matter is, though we're measuring what's going on in the bladder, it's a very artificial setting. Now, there are some people in Europe and some other places that do ambulatory urodynamics where the patient can walk out of the office, walk around. But again, you're still walking around with a bunch of catheters coming out.

So the whole idea here is this is something that is easily placed into the bladder. And actually, the current model, it looks like just a little curl from a double J-stent. And it's placed in and then it sits and floats in the bladder and it's attached by a string to the outside world. And what you can do is then just let the patient get up, walk around, do their own thing without any catheters coming out, without anything external except this tiny little string. And this device measures bladder pressures and things of that sort. And afterwards, there's different ways of doing it. They either walk around with a little pack where all of the information is being transmitted to, or afterwards you can recover the device and then just pull it out with a string and theoretically get all the information that was stored on it.

Diane Newman: So would you put the little device with a string in the office and then you'd send them home, and then almost like a halter monitor?

Howard Goldman: Yes. So the big picture idea would be this is almost like a Holter monitor for the bladder where you put this thing in, send them home for 24 hours, 48 hours, and you can even have them pull it out. And theoretically, as it's commercialized, put it in an envelope, send it to the commercialization, the company that's working with it, and then download all of the information. Alternatively, it could be continuously all the data transmitted to their phone. So a lot of different variations on it. I believe with commercialization the first use is going to still be in the office where it will be put in and then they walk around outside or in the office area for an hour or two and then come back and it's retrieved.

Diane Newman: Now who's the company that you're working with to develop this?

Howard Goldman: So there is a company called Bright Urology that is commercializing it. This originated at the Cleveland Clinic. And I think they are partnering with Bright Urology to take it forward.

Diane Newman: So this is really your innovation from the Cleveland Clinic, then?

Howard Goldman: Yes. Again, I want to be clear, it's Margot Damaser's lab, Steven Juris, a lot of very, very smart people who are a lot smarter than me. I was fortunate to be the clinical person who worked with them and a lot of our fellows and residents.

Diane Newman: Now, did you test this on men and women, adults, children?

Howard Goldman: So the initial study, which is actually has just been accepted for publication by the Journal of Urology, so it should be out very soon, was on women. And we tested it on 11 women who were going to get urodynamics anyways. And what we did is we ran a standard traditional urodynamics, then we placed this device, ran it with the Uromonitor, and then we did a combination. So we had both systems working at the same time. And then we were able to, first of all, look at tolerability, comfort, how easy it was to actually do. And the second half is we actually were able to look at the simultaneous tracings and see how closely they matched each other.

Diane Newman: Well, and when you talk about urodynamics, I think that the male actually hates it the most, putting that catheter into their bladder. So do you see then the application also in men?

Howard Goldman: Yes. So the company and the lab have developed a sort of application device where it will be able to be passed through the urethra and then sort of push it into the urethra and then it gets that little curl with the long string hanging out. And so the male can then walk around, do whatever they do, and then it can just be pulled out via the string.

Diane Newman: Well, and this has application of course in individuals who have, say, incontinence, overactive bladder, but also in the neurogenic population, correct?

Howard Goldman: So in the neurogenic population and the other ones you mentioned, but also, to me, it also has a lot of application in those with true voiding dysfunction because some of these patients in the lab setting are just have difficulty voiding. And you want to get a pressure and you want to get a flow and this and that, and then they come and they have a lot of hard difficulty urinating. So this, there's nothing like being in your natural environment. And I think we'll be able to get a lot more information in those specific groups as well as all of the other standard groups that we utilize. So something to note is most purist urodynamicists would say, "All you're getting is bladder pressures. So how are you differentiating between Valsalvas, between overactivity, things of that nature?"

So I will tell you that from years ago, the same group out of Margot's lab, and we were involved as well, we have developed very fancy algorithms, which essentially we were able to train the computer, the device, to be able to recognize the difference between a Valsalva and to choose your overactivity pressure curve. And we are able to essentially, within about 98% accuracy, tell the difference with just one pressure. So instead of subtracting the abdominal pressure from the total vesical pressure and therefore getting the [inaudible 00:06:46] pressure, we're just getting the total vesical pressure. But we can tell by the different formation of the curves if it's overactivity or a Valsalva.

Diane Newman: So this is really the next step because everybody talked about ambulatory urodynamics, how that was going to be great. Because exactly what you're saying, you're not sitting on an exam table with your legs separated or whatever, and not really a normal position for voiding. And this actually will normalize this a little bit more as a diagnostic.

Howard Goldman: Correct. And this will be integrated with the patient. Theoretically, we'll take home with them a little flow, a cup that is wirelessly integrated so the flow can be matched exactly with the pressures. And we can have a regular pressure flow essentially readout, just like we do with standard urodynamics.

Diane Newman: Yeah, I'm glad you mentioned that because I was wondering, what about the uroflow? So then you're right. And there's now technology that that can be done in the home very easily.

Howard Goldman: Correct.

Diane Newman: So you're going to be publishing this information, then?

Howard Goldman: So this first group of patients is currently impressed with the Journal of Urology. And we actually have the second portion of the study looking at neurogenics. So we are currently enrolling. We've already done a few patients, women with multiple sclerosis. Same situation, they were going to get urodynamics anyways and we do with your monitor, with catheter, and then combination.

Diane Newman: And then compare. Are you going to be looking at spinal cord injury patients?

Howard Goldman: Ultimately. Not yet.

Diane Newman: Okay. Well, thank you very much because, I mean, we're really interested in new technology. And in this area, I agree with you, men and women don't like urodynamics, okay? And they talk about the fact and they don't want to have them. And actually, I feel we should be doing more analysis of what that bladder function is. So this might be really great technology to get that information we need.

Howard Goldman: Yes. Hopefully we can get more real life information over even a longer time span with better comfort levels for the patients.

Diane Newman: So then you'll know if they're drinking something, what their normal life is as far as what's going on over a several day period is what you're saying.

Howard Goldman: Correct. I mean, again, the way we do it now, it's fine, but it's an artificial setting. And there's nothing like getting that information when the patient's doing what they do on a daily basis.

Diane Newman: Well, thank you very much for sharing this with us.

Howard Goldman: Thank you.