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Evolving Intermittent Catheter Technology: Review of Materials

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Evolving Intermittent Catheter Technology: Review of Materials
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Diane Newman: Welcome. I’m Diane Newman. I’m an adult nurse practitioner, adjunct professor of urology and surgery, and a research investigator senior at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia. This presentation, I want to present to you coding technology for hydrophilic catheters, in those catheters we use intermittently for intermittent catheterization. This is just a very quick timeline on where we’ve gone with catheter technology.

When you look at this, it’s astounding to know that we’ve really evolved in what we now use, and for intermittent catheterization, what we’re teaching our patients. We’ve really moved away from red rubber catheters. There’s been such a concern about latex now, latex acquired allergies, especially in the healthcare environment, amongst nurses, even, that you can imagine that we really don’t want to use a red rubber catheter anymore. That’s now really kind of been a couple hundred years old now. That’s something that’s really outdated.

We’ve moved now to much more hydrophilic coated catheters, and catheters that we’re finding are much better for the patient, and actually much better for their urethra, so very important. It really enhances that experience for that person performing in catheterization. Material has been around, and this slide just gives you an idea of the different types of material that we’ve seen in catheters used intermittently. The rubber latex was the most flexible. Of course, latex allergy is concerned.

PVC, that’s been around a long time. Basically, that’s a very inexpensive type of catheter, tends to be stiffer. PEBA is a PVC free plastic type of material, durable and flexible. Then we have silicone catheters, which we have found when used for intermittent catheterizations is they can really maybe be too flexible, and they’re not easy to pass. Then we have what we have used mostly in the hydrophilic catheters that we’re using, PVP, and that’s really the basis of most catheters that we use for hydrophilic.

You have to realize, though, with those is we have the material is that for the hydrophilic layer is adhered to the surface of that catheter. Where have we gone with design changes with technology advancement in this area? Really, what the focus has been on polymer properties, latex largely has been replaced by silicone, polyvinyl, PVC, or organic PEBA. There’s advantages when manufacturing these products: reduced costs, of course, and then of course, the concern has always been whenever we’ve seen design changes, is there a concern with an allergic reaction from the patient?

The hydrophilic polymer coating, as I said, allows that catheter easily pass through, because it binds a large amount of water. It produces a very slick, hydrophilic, hydrated layer on the catheter surface. It reduces the friction between the catheter and the urethral tissue as you pass it, especially in a male urethra, which is very long in length. There’s less force that you need to pass that catheter and insert it into the urethra. It really, the data is showing it stronger and stronger as far as the fact that it decreases trauma during catheterization, it’s more comfortable, and it improves ease of use.

The problem is, there’s different types of ways you put on that coating to make that surface hydrophilic. That can be a problem for certain individuals who maybe have problems with dexterity, as far as manipulating the packaging, and all the material that you need to coat that catheter. There can be problems with hydrophilic catheters. They can be painful because they dry out. There can be friction sticking when that catheter, in time, it starts to dry out causing hematuria trauma, and then it can lead to difficult catheterizations. That problem is, and then you have patients forcing that catheter through the urethra.

Again, it can cause strictures, and of course it can cause a catheter-associated urinary tract infection, because the urethra is traumatized, bleeding, bacteria may be introduced into the system. Now, there has been some evidence in the literature about hydrophilic catheters. There’s actually been quite a big few publications. I do have a reference list at the end of this lecture that you can look up this information on your own if you are so inclined.

Basically, the data and the scoping review, which is published this year, so it’s very recent, in neurogenic and non-neurogenic patients who had urinary retention, they had better outcomes with hydrophilic coating. What were the better outcomes? Satisfaction, preference, less adverse events, which I just mentioned that can occur. UTIs, quality of life was better, cost effectiveness, and less pain and discomfort. This slide is just showing you that all in all, they’re positive, pro. That’s HCIC, hydrophilic coated intermittent catheters. They really scoped out many, many different publications.

They’re showing that impact on UTIs, very positive as far as decreasing UTIs. Again, this is another one. You see that all at the bottom, decreased pain and discomfort. We’ve known this quite a well. Actually, the EAUN guidelines in 2013 concluded that hydrophilic catheters reduce pain, and that most patients prefer them for comfort. I think that’s something that we have to remember. This is a great study, scoping review, because they looked at spinal cord injury, they looked at spina bifida and mask EPH. They looked at a large number of patients, which both men and women, showing that, yeah, it’s just more comfortable for the patient to use a hydrophilic.

There’s no question that this technological advancement has really been positive. We realize that. We do have some data. We do know patients like these, and we do know that that hydrophilic catheter really adds that smooth, wettest surface as you pass that catheter through the urethra. Thus, hopefully lower friction, lower force, less microtrauma to that catheter. Okay, so that’s really important.

Let’s talk a little bit about this, as far as these catheters. They do dry out. It’s a slippery type of stickiness that can occur when they dry out. If we go back to the Mandy Fader article in 2002 that she asked about this. Her aim was to know if there was sticking. When she says adherence, she means adherence of that sticky part of the hydrophilic coating during withdrawal. It depends, of course, on timing. You put it in, and as you withdraw, is it drying out and sticking to the urethra? She would want to know about smoothness of catheter removal.

She looked at 61 men around the mean age of 54, and she compared four different hydrophilic catheters back then in 2002. I have to stress to you, technology has evolved since then. We’re always seeing new designs and new types of coating. She looked at catheter comfort on insertion, removal, comfort on the bladder and the penis in these men. She also looked at smoothness of that removal, and then whether it was sticking. I think these results are somewhat surprising. We may find these results surprising, but sticky occurred with removal on all four of these catheters that she tested back then.

This is kind of what the subjects, the patients were saying. Oh, okay if you like being turned inside out. One-fourth sticks inside like adhering glue, ugh. Stuck badly, quite painful to remove, dried out very fast, and gripped on tight to the penis wall. Again, small study, 61 men. The point is that there was some sticking occurring there. You see this down here on that one question when she asked about sticking on removal, a little or a lot, and those are not insignificant numbers.

These are the four different types of catheters that she tested. Again, this technology probably is old, it’s evolved since then, but it’s something that was starting to be discussed in this field. What you see from that is that the findings here indicated that there were differences. This is important. Not all hydrophilic coated catheters are the same. We don’t know how much really that’s occurring, but we do have some more data as far as what happens with removing that catheter.

Actually, in 2016, there was actually a validated questionnaire that came out called Intermittent Catheterization Difficulty Questionnaire. I’ve used this in research, and they actually put a question, look at that question number 11: I have a blocking sensation during catheter withdrawal. They were asked about the frequency of that occurring and the intensity. You see that evolution from 2002 to 2016 to actually see if we could document this in some research that we’re doing.

Actually, in a study that I have done, which was supported by Wellspect, on 200 patients performing catheterization, mostly men again, and they have been performing at UC for a long, 90% for one year, and mostly spinal cord neurogenic type population here. We did ask this questionnaire and we did publish this data. Now, that question on there, “I have a blocking sensation during catheter remove,” yes, some individuals did have that. We’re starting to see more and more, as far as is there a problem with removing these catheters, as far as maybe possibly sticking to the urethra?

It’s important to understand that we’ve had catheters on a long time, okay? Designs have really evolved, technology has really expanded, and we have better and better catheters to teach our patients with. We have to realize that hydrophilic has a lot of positive, as far as them being applied to catheters that we use intermittently, but they can dry out. What we need to understand more is what’s happening there, and can that drying out cause some trauma to that urethra?

What I want to direct you to is in part two, I want to talk to you about the newest technology that we have. It’s called Field Clean technology, whereas opposed to adhering that hydrophilic coating, the hydrophilic components are embedded into the surface of the catheter. I hope you listen onto part two.

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