Diane Newman: Welcome. I’m Diane Newman. I’m a nurse practitioner and continence nurse specialist. I am the editor of the Pelvic Health Center at UroToday, a website that specializes in urologic conditions. I’m also a practitioner at the University of Pennsylvania in the division of urology.

I’m here today with a very important guest, who I actually met here in Barcelona at the EAUN, which is the European Association of Urology Nursing. I’m very happy to introduce Dr. Daniela Andrich. She’s a urologist who is now in the United Kingdom, correct?

Daniela Andrich: That’s correct.

Diane Newman: Tell us a little bit about yourself.

Daniela Andrich: Yeah, thank you, Diane. Thanks very much for the opportunity to be here. I’m a reconstructive urologist in London at the University College London Hospitals, which is a big university hospital in the UK. I’ve been there for some time now and I work in a very specialized field of urethral reconstruction. That means that patients who have scarring in the water pipe in the urethra require, usually, surgery to help them pee again.

That is a very small niche surgery not a lot of doctors know or hear about, but it can be a very significant long-term problem for patients, and that is my specialty.

Diane Newman: Do you see men and women with the problem or primarily men?

Daniela Andrich: It’s primarily men who are affected by urethral strictures. Occasionally women have strictures as well, but that is not as common as in men.

Diane Newman: I want you to know why I asked Daniela to come here today. We’re doing a little show-and-tell here at the meeting, and I was fascinated by your new technology-

Daniela Andrich: Thank you.

Diane Newman: … that’s specific for catheterizing men that are difficult catheterizations.

Daniela Andrich: Yes.

Diane Newman: I’ve been a urology nurse since the 1970s, and I have to tell you, they’re not that rare, are they?

Daniela Andrich: No.

Diane Newman: They’re actually fairly common.

Daniela Andrich: Yeah, they are…

Diane Newman: You know, because the long male urethra, the enlarged prostate, and as a nurse we don’t have a lot of tools to assist us to really decrease the trauma that a catheterization can become, right? It can be very traumatic.

Daniela Andrich: Exactly, exactly, exactly, and that insight is what I have addressed, because we have, in clinical practice, really for a long, long, long time, very safe guidewires which help us insert any tube into the body, but for one or the other reason, I can’t tell you, in the urethral catheter sector, that has been ignored.

Now, in the vascular catheter sector, you insert absolutely every long vascular catheter over guidewire. We call that technique, utilizing a guidewire and a catheter together, the Seldinger technique, that a catheter is inserted over a guide which first finds the end location in the body, a safe guidewire, and then the insertion of that vascular catheter. We use that for donkeys. But, in the urinary tract, we have, actually, for some reason or another, not developed that.

And, yes, and probably because of my specialty as a surgeon, I just had maybe that little bit extra insight that I realized it is not good enough that I just teach my residents to use a guidewire, then somehow improvise, cut a hole in a standard catheter, which we have done for ages. But this is not a transferable skill, because, hey, a catheter is a properly regulated device. You can’t just all of a sudden say, “Hey, why don’t you do that?” But within the surgeon’s culture, this John Wayne approach is sort of still accepted or acceptable.

Now, in the nursing profession, which is actually working towards higher regulated standards, you can’t do that. Yet nurses, certainly in the UK, are the ones who actually catheterize patients, and when it is difficult, it is not because you don’t have the technical skill to pass a tube, i.e. the catheter, into the penis and then push it further until it reaches the bladder. The problem is when the prostate is too large, and that happens in elderly men.

And, heck, we have men who get older and older, they’re not only … They have surgery, and when they undergo surgery, necessary surgery, for example, cardiac surgery, which is a major invasive process, you need to catheterize the men so that you can monitor the urine outputs so that the anesthetist knows how the body, the physiology, is working.

So, the patient is put asleep, prepared for surgery, and then you actually find out that this catheter doesn’t go in. Now, with that particular group of men, you need to know that, after this cardiac surgery, you need to be fully anti-coagulated at the end of the procedure. That means if there is any bleeding at the time …

Diane Newman: Right, any trauma to the urethra, they’re going to bleed.

Daniela Andrich: This is unstoppable. This is a risk to the patient, which is, actually, it is like a crash off a jumbo jet. You can’t do that.

Diane Newman: You’re right, but I’ve had a couple of cases in my hospital in Philadelphia where it wasn’t even the prostate. It was just really the positioning and the inexperience of the individual who was catheterizing.

Daniela Andrich: Exactly.

Diane Newman: And you’re exactly right that urology was called in because of abnormal bleeding pre-cardiac surgery.

Daniela Andrich: Exactly.

Diane Newman: In one case they actually had to cancel the surgery. So, I was really impressed with the fact that you’ve integrated the stent into the catheter.

Daniela Andrich: I show-

Diane Newman: So, what I’d like to do … Yeah, so …

Daniela Andrich: Yeah, so, I show you, because, really, what the insight of this innovation is, is just that you realize you have to put two devices, the guidewire, and the catheter, together into one regulated device so that you can test it, approve it for everybody’s use.

Diane Newman: So, what I’d like you to do, Daniela, is really show us your product, your new catheter with the stent, and then I want you to demonstrate how we would use it as far as catheterizing a male.

Daniela Andrich: Exactly.

Diane Newman: And we have our model here so that you can demonstrate for us, okay?

Daniela Andrich: Yes, yes, yes, yes. So, Diane, the beauty of this is now you have actually a consumable with a five-year shelf life. So, whenever you come into the situation where you have the need for catheterization, wherever that is, you find out, “Oops, it doesn’t go in.” Now, the importance is, you have a sensation that there is resistance, and everybody has that sensation. So, you just don’t have to push. You now can actually turn over and get this consumable ready to stock on your catheter trolley, and be ready for that eventuality, so you have now a plan B.

And you have here a very simple eco-friendly package, so the external sheets … This would be, then, a sterile surface. I would be scrubbed, with gloves. That’s now infection control, really a sterile procedure. So, you first open the external sleeve, all sterile, and you would put that onto your sterile work surface.

Here we go. So, now, I’m gloved, right? I’m gloved. So, all we have to do is actually, then, after you have opened the sleeve and put that onto a sterile surface, you have to open the upper end, and that nicely tugs off, and you expose the irrigation channel of the integrated guidewire.

Diane Newman: This is a three-way, is that-

Daniela Andrich: That is a three-way catheter.

Diane Newman: And what French size is that? That’s a 16, right?

Daniela Andrich: That is 16, and that is really the best sort of intermediate size.

Diane Newman: Sure.

Daniela Andrich: You don’t need anything bigger; you don’t need anything smaller. That’s the best drainage caliber for a standard catheter. We have here the valve. The 16 is … The orange is the symbol for a 16 French. We have the urine drainage lumen, and here we have the third channel, the irrigation channel. In that irrigation channel, we have integrated the guidewire. 

Diane Newman: Oh, I see, okay.

Daniela Andrich: And that’s where the patent lies. Quite clever patent lawyers I have, I must say.

But, it is a very, very simple solution, and that is the key. It isn’t complicated. All you need to do to get ready is to insert the syringe with water or saline and flush that through. As you have that sleeve here still intact, you can see that here, it will accumulate at the bottom. So, you really automatically flush the entire length of the guidewire. That’s all it takes. When you remove the syringe, just make sure that it doesn’t accidentally clip off. You want to have it attached for insertion.

Diane Newman: Oh, I see. So, that’s the syringe right there.

Daniela Andrich: That is important because it is normally quite clicked in properly, but you could if it happens …

Diane Newman: Sure, you may pull it out with … Yeah.

Daniela Andrich: You know, accidentally pull it out, but you want to put it back in. Now you’re ready to go. You have activated, lubricated the guidewire. Now you just really go over to the patient. You would have draped him anyway, but what you would maybe want to do is just lubricate the urethra a little bit more. You use some lubrication gel. All of that is completely standard practice. And, by the way, when you lubricate, do that slowly so you don’t need to push in a big bolus.

So, you lubricate that slowly, and then you’re going to get ready with your guidewire. So, I quickly have to just do that in two steps, so you really open the rest of the sleeve here, and I just take it out like that. That’s okay.

Diane Newman: Yeah, that’s really interesting. So, this is the guidewire.

Daniella Andrich: This is the guidewire.

Diane Newman: And it’s just coming out of the tip of the catheter, or where is it coming out of?

Daniela Andrich: So, indeed, we have here a completely atraumatic standard Nelaton tip catheter end, yeah? So, normally a three-way catheter is really a long end with a big balloon. We have actually here the standard end of a two-way French catheter … Sorry, two-way catheter. So, you have a round edge. The guidewire comes around here, so just off the tip, so you have a completely smooth surface like with a normal Nelaton tip catheter and then a 10 mil balloon. So, that its own right-

Diane Newman: What is the material of the catheter?

Daniela Andrich: 100% silicone.

Diane Newman: Oh, it is 100% silicone? Okay.

Daniela Andrich: Oh, yeah. We shouldn’t use any latex anymore. This is crazy.

Diane Newman: No, we’re really getting latex-free in the United States, you’re right.

Daniela Andrich: Exactly.

Diane Newman: But urology has a lot of latex-based products.

Daniela Andrich: Yeah, I know, and, I mean, we are latex-free in my hospital now for a long, long time.

Diane Newman: Oh, really? Yeah.

Daniela Andrich: And we also actually got rid of female catheters. We just really don’t want to have a risk that, in areas like that, actually …

Diane Newman: Interesting. So, it’s 100% silicone.

Daniela Andrich: It’s 100% silicone, and your guidewire is lubricated. It doesn’t need a lot of lubrication in any case. And then, really, the only thing you want to do is just make sure the penis is stretched, and then with even movements, you insert the guidewire. That is a very simple procedure. Nurses sometimes are not used to use guidewires, but it is as simple as that. You’re just trying to have-

Diane Newman: Well, it’s much simpler passing guidewire than it is an actual catheter.

Daniela Andrich: My God, you know, and look at that? I mean, you advance the guidewire into the bladder. Now, that curls up in the bladder. We have actually here the advantage of a model, where if I would tilt it, the cameraman could even see it.

Diane Newman: That’s okay. You could see that that could curl.

Daniela Andrich: It is, indeed, curled up in the bladder. The guidewire is completely atraumatic, and then you just really advance the catheter into the bladder. It couldn’t be easier. General teaching would be you insert the catheter all the way-

Diane Newman: To the hub.

Daniela Andrich: To the hub.

Diane Newman: That’s what we do. That’s very standard, sure.

Daniela Andrich: And you still want to wait until urine comes out, and then you block the balloon.

Diane Newman: So, you inflate the balloon while the guidewire is still in place.

Daniela Andrich: Indeed, because you really don’t want to make the accidental mistake that somehow the whole thing, after all, could go …

Diane Newman: Okay.

Daniela Andrich: You know, this patient is actually very cooperative, but I should say, actually, catheterization isn’t a pleasant procedure.

Diane Newman: No, right. Especially for men, no.

Daniela Andrich: It isn’t. But this is actually 10 times more pleasant than repeated attempts and then, alas, if you have trauma. So, I’ve just blocked the ballon, yeah? So, I have slowly inflated the balloon. You need to push the syringe in a little bit and then really push it in all the way and then disconnect it. So, now the balloon is blown up. We can show that in a second how that looks, but now the guidewire comes out, and it is so easy. Just a little tug, out it comes.

Diane Newman: So, you just pull the whole … How easy, huh?

Daniela Andrich: Yes, it is. I mean, it couldn’t be easier. Now, if you wanted to irrigate, you could use irrigation through this catheter. Or, but it’s also quite nice sometimes, you can take actually through this port, now, a urine sample. You have a bladder urine sample. And then, of course, if you don’t need any of that, you just clip that off.

Diane Newman: So, you’re capping that.

Daniela Andrich: Cap it off. No other thing necessary, and then just tug it back a little bit, and the job is done. You have no interruption. I mean, literally, the interruption is to turn over into your catheter tray where you have the second line catheter stored, and there is just no waste of time. There’s no waste of other catheters. Often the scenarios are difficult-

Diane Newman: You’re right. With other catheterization-

Daniela Andrich: Another one, you know, the different size …

Diane Newman: You’re right. We get another one, another one, we change the sizes, whatever.

Daniela Andrich: No, no.

Diane Newman: And like you say, it just traumatizing the cath patient more and more, because you do maybe sometimes three or four attempts to try to get the catheter in.

Daniela Andrich: Oh, yeah. Yes, yes, you see, and the thing is, one mustn’t forget, this is usually a very stressful situation. I mean, if you are the nurse practitioner, in cardiac surgery it seems to be, I think, very much the practice now that you have specialist nurses who do the catheterization. You know everybody’s waiting for you. This is all of a sudden high pressure. It is, of course, none of your fault. The prostate is just large.

What the cardiac surgeons actually now do, they apply the IPSS questionnaire, which is very smart.

Diane Newman: Oh, they do, really?

Daniela Andrich: Yes.

Diane Newman: Really?

Daniela Andrich: Because that is-

Diane Newman: The International Prostate-

Daniela Andrich: The International Prostate Score … I mean, it’s self-evident to do that, because they’re all pre-assessed. This is major surgery, and the pre-assessment nurse just … You know, it’s one simple questionnaire, and you can screen out those patients who have a higher score, who are likely to have a large prostate gland. They use that as a priming tool. Why not?

Diane Newman: Sure, so you identify those at risk-

Daniela Andrich: It is completely …

Diane Newman: Pre … And, like you say, this would be something, I think, that really the first application would be in the OR where they have to catheterize an individual male.

Daniela Andrich: Exactly, exactly.

Diane Newman: And you often don’t know who is and aren’t at risk, so, to me, I always say maybe that we should just do every male as simply as we can in the least amount of difficulty because the trauma can be really quite significant.

Daniela Andrich: Do you know what? And, absolutely, I agree, Diane, and we are now very, very aware of catheterization-associated urinary tract infections, but what one probably doesn’t appreciate enough, as soon as you breach the integrity of the urothelium, so, the lining of the urethra, you really allow bacteria direct access into your bloodstream, because the urethra is a modified blood vessel in the end. That is the real risk, that you have really a patient here who is exposed to urosepsis.

Not just a little bit, a few bugs in the bladder. That is sort of what you get when you have an indwelling catheter with colonization and biofilm formation on the catheter lining when it is in the bladder for too long. But, you have here a situation when you traumatize the urothelium, you allow bacteria, and there are 200 to 500 bacteria in your bladder. You give them direct access to your bloodstream.

Diane Newman: Right to the bloodstream.

Daniela Andrich: And one completely hasn’t got that [inaudible 00:15:38].

Diane Newman: No, I think that’s been pretty well-established that difficulty with catheterization in the male patient specifically-

Daniela Andrich: Huge problem…

Diane Newman: … can lead to a catheter-associated UTI.

Daniela Andrich: Yeah, yeah.

Diane Newman: Well, I thank you very much.

Daniela Andrich: Yeah, thank you.

Diane Newman: I appreciate you coming.

Daniela Andrich: Thank you.

Diane Newman: Like I said, I was very excited when I saw you here at the meeting.

Daniela Andrich: Thank you.

Diane Newman: And I thought this would be something that would be of interest to our audience.

Daniela Andrich: Yes. We have, actually, FDA approval almost. Yeah, we will have that probably in a few months time. We’re just really going through that, and the FDA, I think, are really very supportive of that. So, I’m coming to the AUA, as well. I go to SUNA, actually, on Wednesday.

Diane Newman: So, we’ll see you there.

Daniela Andrich: So, I hope I see you again. Thank you, Diane.

Diane Newman: So, thank you for listening. I’m Diane Newman, nurse practitioner and the editor of UroToday’s Pelvic Health Center, and I wanted to show … We’re doing a little show-and-tell here, and I wanted to show some new technology, which is a guidewire integrated into an indwelling Foley catheter that we could utilize for those difficult catheterizations that we see almost on a daily basis in urology practice. So, thank you.

Daniela Andrich: Thank you, Diane.