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With the bevel facing downward to the posterior, begin the needle insertion approximately one to two centimeters above and orthogonal to the probe. You may refer to the bevel indicator on the needle hub for correct orientation of the bevel. Angle the needle over the rectal hump through the perirectal fat and under the Denonvilliers' fascia. Advance the needle to within zero point five centimeters of the base. Switch the probe to axial view to confirm needle tip placement. Switch between sagittal and axial views as needed for confirmation. Wiggle the needle to confirm the needle tip is not snagging rectal wall or prostate. Inject a zero point five cubic centimeter bolus of gel for final needle tip confirmation. If you prefer more coverage superiorly, you may advance the needle tip for injection between the seminal vesicles and the rectal wall. Continue to retract slowly while injecting with the needle just below the Denonvilliers' fascia. Keeping the needle in place, attach syringe number two. Rotating the probe laterally on sagittal view helps confirm gel coverage. Steer needle tip laterally for touch up if necessary. Switch to the third syringe and begin lateral touch up. Barrigel does not polymerize, allowing the physician to touch up any necessary areas to optimize spacing laterally. Notice the consistent spacing from base to apex.

Now I'm going to go ahead and place the Barrigel. Needle primed. So the needle's been primed. We've got a red mark on the needle. We're going to put that towards the floor so that the bevel's in the proper position. I like to start at the midline and the goal is to go over the rectal hump. So we wanna go in on an angle like this, go over the rectal hump, somewhere towards the midglam. So I'm going to go ahead and insert the needle. Again, I like to kind of watch the needle for the entire duration, and I'd like to see the entire length of the needle on my screen. So again, I'm going to look at my probe, I'm going to go immediately above it, by about a half to half an inch to an inch, and I'm going to go ahead and pierce the skin. I can scroll back, and you can see my needle tip there. And we're going to go ahead and I'm watching the screen. So I'm not watching my hands, I'm really just watching the ultrasound screen, I want to see my needle tip. I try to stay closer to the prostate, because I really don't wanna pierce the rectal wall. So I just kind of hug the posterior aspect of the prostate. You can see that I'm into that perirectal fat, which is that white line immediately underneath the prostate. And I feel like I'm in a good place here. And we can verify that by going to our axial images. So you can see my needle tip. Right there. And you can see that I'm not into the rectal wall, which means I'm in a reasonable place to start my Barrigel placement. You can see that as I insert the Barrigel that we are now getting separation between the prostate and the rectum. And it's kind of going to the path of least resistance, so you can see it's moving over more to his right side. And we can kind of scroll in and see how much we're getting towards the base. I can pull back and we can get more towards the apex. You can see that we have a pretty good layer already going from base to apex. Now for whatever reason it seems to be favoring one side, his right side, so the nice thing about Barrigel is we can go back and we can place more wherever it's needed. So I've gone through one vial. I'm going to go ahead and add some more so that was just three cc's to create that much separation. I like to go back to my sagittal view as well. You know, of going back and forth between axial and sagittal I think is always a kind of a good idea. So you can see the right side where it was kind of going in the path of least resistance, we actually have a pretty fantastic layer already. Not quite so much at the midline, not quite so much going back to his left, But again, we can kind of fill this in. So the key to me is always to be able to see your needle as you're inserting. You can see that I'm getting a really good layer here at the apex. And what I always kind of like to see, and this is actually a beautiful illustration of this, is there's fat actually on both sides of the gel. So the white again is the fat. So you can see that there's a fat layer here and there's the fat layer on top that just tells you once again that you're in the right spot. We will use a third one. So all I'm doing is I'm using the stepper stabilizer to kind of rock through both sides of the prostate, we can see if I go all the way over to his right side, you can see that there's a fair amount of distance now between the rectal wall, is down here, and the posterior aspect of the prostate, which is all the way up here. So we can even measure that. You can see that we're looking at at least nine millimeters, it's probably a little more. So I'm pretty happy with where that is. But if I come over to the midline. It looks good there. If I come over all the way to his left side, it looks like we could use some more over there. So again, the beautiful thing about this is I can add wherever I want and As long as I can see the tip of my needle, I know where the Barrigel is going in and we can just lift that prostate away from the rectum. I'm going to scroll through again. And I'm just rotating. Now we'll go back to our axial images, and I still have another CC or so left and we can see if we want to fill in anywhere else. So you can see all the way up at the apex how much coverage we have. This is toward the base. Mean one thing you know we always kind of talk about is how much is enough. We can kind of measure here and we can see do we want to add something or not. So this is at the base of the prostate. Again this would be so maybe six and a half here seven so if I'm going to add anything probably that's where I'm going to add. Let's take a look. You can see here this is more towards the mid gland. You can see more like seven and a half. This would be what I would consider to be the apex. So nine and a half. So I think our apex is pretty well covered here. I think if you want to see kind of what it would really look like when he's actually getting treatment, we do put anterior pressure on the probe to get good pictures. The reality is that it's going to decompress when there's no probe in there, which is how he's going to be for post seed implant. And that just opens the space obviously up even more. So now we guess we could do measurements. These are probably more realistic measurements. So here we are at the apex. And this to the rectal wall, you're looking about more like twelve or thirteen. We can go in a little bit further. So this is more towards the mid gland. This is probably more of the mid gland. I'm do some measurements here. So more like ten millimeters. And then even here at the base, you know, again, the question is, do I need to put anything more? The reality is here's the distance that I have. So maybe seven and a half. So since I have an extra cc, what I'll do is I'll put in a little bit more right there. Maybe right around here. And we'll kind of see what we have. So again, I put that little pocket in. I'm not so sure I made a whole lot of difference, but either way, you know, a pretty huge distance between the posterior aspect of the prostate, and the rectal wall. So now that we're finished with that part of it, we're going to do our volume study and then we'll be all finished.

So this is the midline approach for Barrigel. You can see the needle going in there. It's, between the rectum and the prostate, and you're looking for that white line, which is the space that you want to be in. And that's the space, that's gonna be safest. It's the space that you know is not gonna be injected into the wall of the rectum. It's right where a Denonvilliers' Fascia is, and you just sort of advance the tip of the needle, you can see the needle the whole time, you know where you're going, right to the base of the prostate, and once you're in that space, you can go in an axial view and really make sure you are not in that rectal wall, you can lift up on the needle, you'll see that in a second, there's the tip, you lift up a little bit and then you inject and you can inject and also get a lot of tactile feedback at this point to make sure there's no resistance, it should go in very smoothly, You shouldn't feel resistance in this spot or else you might think twice about exactly where you are. And then you go back to that sagittal view and you've got a nice pocket of gel right at the base and then you just sort of pull the needle backwards slowly, keep it sort of at the top part of the gel that you just made inside the gel, and you saw something just kinda open up there, and then you just slowly move backwards. And sometimes, just keep moving backwards all the way, and it's just a great space that you made. Other times you'll find that there's some resistance maybe at the mid part of the prostate, which you'll see here, a little bit of resistance as I'm moving back there. Maybe the gel's not going in quite as easy as it did before. You can feel that the entire time, but you just sorta feel that area, make sure that if you need to re advance, you're in the gel, which is the safe area. And then you can sort of push upwards on the needle if you need to. And that sort of maneuver will help you, open this base up, make sure that you're dissecting it, and make sure that you're opening it up as best as possible so you can place the product. Here's what I was talking about. You see it's scarred there, probably from previous biopsies. It's not too uncommon to see that, but we have all the time that we want to take to open this space up. We can take as much or as little time as we need. A lot of times I find that these spacing cases go pretty quick, but sometimes they don't, and that's okay. And so we go back to the Axial View here to check on our symmetry, make sure that we're developing a good space that's covering the prostate and lifting it up equally, throughout. And then you find your needle tip and you can sort of identify where you might have a paucity of gel and you might have to go back in there and sort of add some more. And so there's I tend to switch, between the two a lot just to make sure that I'm in a safe area, make sure that I'm I'm putting the gel in the in the best spot possible with the best symmetry. And and here you can see I'm probably feeling around to make sure that, there's not too much resistance. I'm sort of pulling back a little bit on the needle, I'm keeping it high, so my hands are low and the needle is high above, above, away from the rectum, And I'm just injecting slowly, and you can see, you know, the gel is sort of slowly making a new space. Some of it's leaking back to the base, and that sometimes happens when they're scarring. On this midline approach, you just sort of check it from the midline, as you're injecting, and then you go left and right in the sagittal view to make sure the gel is, developing a symmetrical space. And if you need to, you can always think about even going in from another spot, just lateral to your central midline spot to inject gel, if there's a lot of resistance in the midline, and so you have all the flexibility to do that. You can essentially do whatever you need to do to make sure that that space is is the best it can be. And throughout this, the tip of the needle is visualized. You know you're not injecting into a place you shouldn't, you have the tactile feedback of the syringe and the gel going in, and you can use that needle to sort of develop the space. You see how the needle is being lifted upwards, and that helps dissect the plane to inject the Barrigel. Here I just turned a little bit to the left to check to see how my symmetry was, and we saw there was a little bit of absence of gel, so I moved the needle over to that space and then we were able to inject some more in order to improve the symmetry, get better coverage. And we can go back to the axial view to kinda check on that and see where we're at. Again, when when there is this scar tissue or this, it's not going in as smoothly as you, as it sometimes does, it's okay. You just have to continue to use the needle, the tip of that needle, to develop the space, and you can see that as the needle's kind of moving upwards and downwards in the gel pocket. And here we go back to the Axial View, where we can see exactly how much symmetry we have, we can see how much space we're developing, we can make sure that all throughout the prostate we have a good, space developed that's going to give the patient the best result as far as reducing their risk of rectal toxicity. Here we're going back towards the apex to check it out and see exactly what kind of, gel we might need to inject there. The tip of the needle is always visualized. You constantly know where it is. You know you're being safe. And and you can also develop with the needle. So when you can see it so well and you can see the gel so well, you can be pretty confident that when you're dissecting, you're just not, you're not doing dissection of a space you shouldn't be in. So I'm moving the needle over, trying to develop that plane to kind of lift that lateral aspect of the prostate up. And a lot of this is intuitive. I didn't have a lot of experience. I'd had no experience with transperineal approach, no experience with spacing, but just from surgical experience with prostatectomies just general urology with prostate needle biopsy, you can use that to sort of develop all these spaces using the needle direct where the gel goes. I found it to be pretty intuitive, and I think most people would. And the best part about it, like I said, is that you have control throughout the entire process. And you can take as much or as little time as you need. Over here, I wanna add a little extra gel, so I'm kinda moving that space, I'm feeling what the needle feels like, whether there's resistance there or not. You can you can sort of move the needle back and forward, and you can see it the whole time, and maybe inject a little bit to see what what kind of feedback you're getting from the syringe. And here, it's it's scarred a little bit over there, but sort of move the needle back and then move it back in in the axial view, little slope steps, kinda like little baby steps moving over there and feeling, to to see what it what kind of resistance is there, kind of inject a little bit. You'll see I inject a little bit of gel here and and it opens it up, you can see it opening up more and more, and the space is developing in a way that's optimal to ensure, decreased toxicity from the radiation therapy they're going to receive. Now we measure it. I tend to measure it still just to see. That's fifteen millimeters, not totally necessary to get that much space, but, you know, there's good symmetry there, and then measure it from the sagittal view, and can talk with the radiation oncologist about what kind of space I'm getting, and and and that can be very helpful for them too sometimes. So the procedure is easy to control. You can know where you're going the entire time. Just need to take your time and develop the space.

Hi, I'm Philip Charlesworth, I'm a consultant urological surgeon and I'm based in Berkshire in London. We begin our insertion one or two fingers above the ultrasound probe angling downwards with the insertion needle with the Barrigel already primed. As we come over the rectal hump, it's really important that we visualize the whole of that needle, particularly the tip. Now with small rotational movements and small movements of your hand, you can keep the tip of the needle in sight the entire time. As you slowly move that needle tip through past the apex, the mid and towards the base of the prostate, keeping the tip of the insertion needle in sight at all times. I've now switched to an axial view whereby small wiggling movements of the needle, we can confirm that we're exactly in that fat space. The rectum is not tenting up below us and there's no movement of the rectum as we move the needle. Now, as we have moved that needle through the undisturbed fat space, we can now safely start our placement of the gel. As you're inserting, you can see the lifting of the Barrigel, it lifts the prostate up and pushes the rectum away and dissects and gel dissects out that space. As we come back to the sagittal view, we can see how that gel has distributed itself nicely in the base to mid of the prostate and we can start building that gel placement up towards the apex. We're coming towards the end of this syringe, so we'll switch out this Barrigel syringe and simply use the next 3cc syringe that's available. It's important as we change that you hold the tip of the Barrigel syringe and as you screw that on to the luer lock of the insertion needle. In this patient, as we slowly bring that needle back towards the apex and we can see that gel dissecting the space out, pushing the prostate and the rectum away. In this patient, we'd lose a little bit of contact from the rectum on the ultrasound probe and this can happen either through a small amount of gas that can get in that area or the patient if they're done under local anaesthetic lifting themselves off the probe. By relaxing the patient and bringing the patient back down on the probe and also by small movements in and out of the probe and left and right, that gas will get redistributed and contact will get reestablished with the probe and we get a nice view of our anatomy back. Now that we can see the prostate and the space and the tip of our needle again, we can safely continue our insertion. One of the other great benefits of working with Barrigel is that you're not limited by the volume that you require per patient. There's no mixing, the syringes are pre filled and are ready to go for each time you want to increase the volume of your space. Now that I've completed the midline deployment of the gel, we can then start concentrating on where we feel that there will be some benefit to the patient and to the patient's anatomy or to gain extra space and to really sculpt it for the individual patient and create a bespoke spacing. I'm concentrating now towards the right side of the patient. On the midline, I was deploying the gel in the sagittal and then confirming its placement in the axial. Once you know that you've got good space, you know where the rectum is and you're away from the rectum, you can also deploy the gel on axial and check on sagittal. In this case, I can see that as we go towards the base on the right hand side, this patient would benefit from some further gel and I can just work slowly analyzing the space and just adding small amounts of gel where I feel appropriate. What's really nice about working with Barrigel is that you can take your time, there's no rush, the patient's comfortable and can insert small areas of Barrigel where you feel the space is required and you can build up a bespoke sculpted area underneath the prostate to really optimize the patient's radiotherapy. I'm now happy with the separation on the right hand side. I'm now concentrating on the left hand side. I've switched to a sagittal view here and as you can see just at the apex of the prostate, this patient will benefit from having a little bit of additional Barrigel towards that left apex. By positioning the tip of the needle exactly in the area, you feel the additional Barrigel is required, Again, we can slowly insert and top up small amounts of gel to build the perfect space. Now that the insertion is completed and the needle is removed, we can check the symmetry and the distribution of the gel and we can see in this patient that there's very nice separation from apex to base and as we rotate in sagittal from left and right, we can see that that placement of the gel goes right the way across and underneath the prostate.

Hello. My name is doctor John Chang. I'm the medical director at the Oklahoma Proton Center, and I'd like to introduce you to our patient today that, we're gonna be working on. This gentleman is a eighty two year old who has an intermediate risk prostate cancer. He has Gleason three plus four disease in about three out of twelve cores, and we're preparing him for spacing today to initiate his, proton therapy. So we typically start out with, obviously, the ultrasound transducer in place. We toggle to the sagittal, imaging, and we initiate the procedure with the needle introduction to the perineum. It's critical to visualize the placement of the needle. And, initially, sometimes if we're not directly over the transducer, we need to modify our approach angle. Sometimes we have to have the proper angle to get over the rectal hump. Sometimes, come in at a at a a higher angle with a steeper approach. The important part about this is to really, aim the tip and visualize it heading towards Denonvilliers' fascia, which is the white strip right behind the prostate and in front of the rectum, which you can visualize now here as we, advanced the needle tip, towards this region. Typically, we will feel a little bit of resistance, initially when we get to that place and then a little bit of, release of that resistance when we properly and adequately find the fascial plane. So I typically like to, when I get into this space, advance the needle tip towards the base of the prostate and even up towards the seminal vesicles, towards the base of the seminal vesicles and and as far as I think I would need to to make sure we adequately provide protection for the rectum, from the treatment to the prostate and and the base of seminal vesicles. So advancing my needle now, getting into that space. We're gonna kinda slowly move it and try to maintain in ourselves in the fascial plane. It's really important to make sure you're in the right fascial plane and, obviously, not into the prostatic capsule and also not into the rectal wall. So you can see here, I'm right towards the actually, into the the middle of the SVs, and I give a little push of the gel, and you can see the Barrigel open up that space. Nice hypo intense appearance to that so you can visualize it very easily. You can see it provide very nice spacing in that area. So as I finish getting the proper spacing, I slowly retract the needle tip back and stay along that plane, injecting a little as I go. And when I finish one syringe, which all have three cc's of the Barrigel in there, I can swap it out, leave the needle in place, and I always try to prime the syringe and needle to make sure that there's no air in the system so that there's no obscuring of the visualization with the air that can come sometimes with ultrasound. So once I have this central axis nicely covered all the way down from base to apex, I then switch to the axial mode to make sure I have appropriate coverage along the entire central axis. So one of the important things here to see is that we got very nice spacing with essentially just one syringe and maybe a little bit more all the way from apex to the base. Some might think that you could stop here, but the important thing is that once we're done with the spacing and if you don't do anymore, that spacing does get a little flatter when, you come back and do the actual treatment planning. So that's why it's critically important to continue the spacing on the lateral aspects of this area. So what I do is essentially rotate to the lateral aspects, of each side of where the central axis spacing has occurred. I first start out in the axial plane to rotate to that level and then use the sagittal plane to, again, make sure my needle tip gets into the appropriate fascial plane. So I'm now on the right lateral aspect heading into Denonvilliers' fascial plane. Again, always visualize where the tip of the needle is, making sure that you're not into the prostate capsule. Okay. So now I'm back towards the seminal vesicles on the right side. Again, placing the Barrigel, which has, again, the very nice hypo intensity on the ultrasound, which makes it easier to visualize. And, again, slowly starting at the base of the seminal vesicles and advancing towards the apex. So you can see here very nice spacing on that right lateral aspect. Now finally rotating to the left lateral aspect. Again, visualize needle tip and advance it to the fascial plane on the left lateral aspect. You can see there's there is already some spacing gel in there that helps as a guide to make sure you're in the right plane. Starting at the seminal vesicles and, again, slowly bringing it back towards the apex.

My name is doctor John Chang. I'm the medical director at the Oklahoma Proton Center. The patient we're seeing today is a seventy six year old gentleman who has a, intermediate risk prostate cancer that is unfavorable due to the possibility of some seminal vesicle involvement. So this patient has disease that is predominantly on the right side extending towards the base and has, some haziness in the area of the seminal vesicles, which suggests the possibility of seminal vesicle involvement. So critical today to do the Barrigel, obviously, to protect the rectum from the treatment to the prostate, but also the fact that we're also going to be aggressively treating the seminal vesicle area. And, obviously, we wanna protect that area away from the rectum as well. And we will, get started with, the Barrigel procedure. So I'd like to initially start, at the center axis. So it's critical to see your needle tip as you introduce the, Barrigel needle in aiming at that Denonvilliers' fascia plane, which is that white strip that's right behind the prostate in front of the rectum. You just make sure you kinda guide it along there. Once you get into the space, you sometimes will feel a little give in the resistance just right there, that when you get into that space appropriately. And what I like to do is really kinda go along that entire length trying to head towards the base and possibly behind even the seminal vesicles, especially if you have a, unfavorable intermediate risk cancer or high risk cancer. I'd like to get some spacing also if I can all behind the seminal vesicle. So I I make sure I get all the way to that area superiorly, and that's when I will switch to the axial plane to make sure I am in the center, axis and then start the dissection. So at this point in the procedure, it's really important to make sure you're in the right fascial plane and, obviously, not into the prostatic capsule and also not into the rectal wall. So to confirm needle placement in the axial view, we toggle to it from the sagittal view and go back and forth to confirm that the needle tip has not snagged the rectal wall or the prostate capsule prior to us injecting the gel. It's kinda lobulated, but, that's quite okay. A little bit of septations, but that still should appropriately, dissect the fascial plane there. So sometimes I will advance and come back just to make sure I get proper coverage. And then as I get towards the apex, I will, use the sagittal imaging to look a little further towards the inferior apex area to make sure I have adequate coverage there. Also important to kinda bring up, and this is something that, before you start your first procedure, I tend to like to place the needle without the stylet in place already having incorporated the, syringe of Barrigel in place. And mainly that's to basically prime the needle so that there's no air in the system. You can see this dissection is very nicely viewed without any artifact of air, and air sometimes can obscure the imaging with the ultrasound. So that's why I tend not to like to use the stylet to to get the needle in place, but I utilize, kinda priming that pump. So once you've kinda done the central axis, I do a nice axial view of the gel placement, and you can see it kinda centers itself on the central axis. And you still have some areas on each lateral aspect of that, central, spacing. And so what you wanna do is now start to consider placing some gel in those lateral aspects just to the right and left of that central spacing axis. So that's what I'm doing here. I rotate the transducer to make sure I'm on the plane that I want to get into. And you can see here that I'm now introducing the needle laterally to the central axis, to basically kinda cover the area that I want to. Again, trying to find the right space, making sure you keep the needle tip in good visual, spatial orientation, get into the that fascial plane on the lateral aspect. You can see that there is some of the gel that's into the lateral aspect, and so you wanna rotate your transducer and make sure you get the needle into the right space, to get further dissection of where you need to. So you can see here, I've kinda rotated, got the needle into the right space. So you see the where the prostate is. You see the rectal wall posteriorly, and then you just advance the needle superiorly to get into the right space here. Again, I'm advancing it along the sagittal plane, along the sagittal fascial plane, and getting towards the seminal vesicle region. And now placing some more gel into that lateral aspect. And this will be the left lateral aspect on the patient. So, again, nice dissection, good visualization of the spacing in that plane. And you can see on the axial how that's opening up well. So, again, scrolling through axially to make sure you have adequate spacing on that side. And you see that's turned out nicely. So now I'm rotating to the patient's right lateral aspect and getting ready to introduce the needle into that area. And the key element here is really always taking your time and making sure, you do this as a nice customized way. The nice thing about Barrigel is that you have the ability to customize the placement of the gel and really take your time, and you're not at the mercy of one push of the gel into the space. You can actually slowly and customize every little aspect of where the gel placement is going. So you can see in this lateral right lateral aspect, there is some gel in that area, and so that helps us a little bit. But, obviously, we need to put a little bit more distally, and I'm doing that right there, kinda covering where the seminal vesicles are, the base of the prostate, coming back towards the mid gland to apex, and obviously opening up that space with, more gel placement there. And, again, good visualization. The Barrigel allows us to see it pretty well with this hypo intensity that distinguishes it from the soft tissue around it. Again, just utilizing the axial plane to look and see the distribution of the gel. And there are lobulated pockets, but, again, overall outcome is that, you have nice spacing from the rectum to the prostate and in the proper Denonvilliers' fascial plane. Afterwards, I always like to take some measurements just to kind of quantify and also from there, also be able to kind of equate it at the or compare it to the MRI, visualization of the of the whole procedure afterwards. I do in the axial plane and, again, also in the sagittal as well.

If I could do Barrigel in every patient, I would be happy. The main advantage with Barrigel is physician controlled placement. You can actually define where it goes, not just hoping that it goes to the right place while you're injecting it, more so than any other product. I'm getting good separation, especially at the apex, and that was an issue for some of my patients that I've done with other products. You're doing the ultrasound, you can see the places that are not filling up well, and you can address those specifically so that the end product is a great implant that gets coverage at the apex, the mid gland, and the base. The ability to sculpt exactly where this gel is going has resulted in a much better DVH for all my patients. They're gonna have a much lower risk of rectal complications down the road. It's very easy to actually incorporate Barrigel into your practice. The learning curve for me has been smooth compared to when I first learned how to do spacers. It's a more intuitive sort of process. The thing with Barrigel is that it's really a gel dissection. You're seeing what's happening as soon as you put in a little bit of that gel and you can actually see very clearly that space open up. There's no need to do hydrodissection with saline ahead of time to make sure you're in the correct plane. It doesn't take me any longer than any other product to administer. In the ten minutes that I take to do the implant, the time is really spent just perfecting your separation and technique and filling in the areas that normally you wouldn't be able to fill in. I think that Barrigel is an incredibly safe compound because hyaluronic acid is a natural compound that the body produces. It's also been used for cosmetic fillers for many years. It's very well understood and behaves in a way that we can control very easily when we're administering it. Barrigel is different than the other products I've used because you actually have control.

I made the switch from PEG Hydrogel to Barrigel. There's a number of benefits from the patient's point of view, there's benefits from the surgeon's point of view, there's benefits from the nursing point of view. For patients having prostate radiotherapy, there is a significant reduction in the toxicity. The key benefits from the nursing point of view is there's no assembly. The gel comes as a unit and you attach it to the needle and you're ready to go. From the surgeon's point of view, it allows me to be much more controlled. There's patients that've got big prostates, there's big patients that got small prostates, there's patients that have got disease at the apex, there's patients who've got disease at the base or left or right or bilaterally. And so you can be thinking about where their cancer is as well, about where you're putting the gel and where the oncologists want their extra margins. When I first switched from using a PEG hydrogel to Barrigel, I was used to hydrodissection because you have to do that with a PEG hydrogel. But actually with Barrigel you gel dissect, so you're putting the needle in the same place as you would do with hydrodissection, but you can slowly build up the gel in the right place as you move it around and you can see exactly where it's going. So I can see that live on the ultrasound. I don't have a time limit. If I can get the spacing in exactly the way that fits that patient according to their prostate, to their disease, to the shape and size of their anatomy. The learning curve for Barrigel is really short. It's a very easy product to use. It's how to put a simple syringe onto a needle and then insert it into the patient. That's one of the easiest things that I do in my clinical practice. When I switched from PEG Hydrogel to Barrigel, found that largely the time it takes to do the implant's about the same. As soon as you get the needle at the right place and you're position checking, you start to gel dissect, largely it's about the same kind of time, but actually you'll spend more of your time making the left and right symmetry and apex to base symmetry perfect. When you start using Barrigel, it is immediately obvious that it is really safe and you're in control. And that's the primary instinct of a clinician and as a surgeon is safety, patient safety. You've got to make sure that there's not any complications and things go exactly as you plan them to. And then there's also this comfort blanket that there is an undo button. There is the enzyme that's available to remove the gel if you need to. Now I've never known anyone that's ever needed it, but it's like having airbags in the car. It's just nice to know they're there. Early on in my spacing experience, had some examples where the spacing that I was putting in went entirely one side or the other side. Since I switched to Barrigel, I'm much more in control of building that that spacing.

Rectal spacing has become critical to making sure we preserve quality of life and use of Barrigel with customized spacing has provided us a tremendous benefit in that realm. As a radiation oncologist, everything we do is about accuracy and precision. We've taken that to the ultimate level with proton therapy, where we're able to deliver focused treatments within less than a millimeter of precision. By using Barrigel, we're able now to customize the rectal spacing with that same level of and precision. When hydrogel was initially utilized, it would polymerize wherever the path of least resistance was. Occasionally that would be into the rectal wall or sometimes into the capsule of the prostate Or it's because the fascia is not as intact towards the apex, we get a much more random spacing in that area, sometimes no spacing. With Barrigel, we can actually sculpt out exactly where we want to put the gel. It allows us to see real time results right at the time of placement and then view those results at the time of our treatment planning. I can customize it regardless of different scar tissue that is formed in the area, the possibility of the cancer being a little bit outside the prostate. This allows me to customize however the body's anatomy dictates. We actually had a patient recently who had brachytherapy and the cancer came back just a little superior to where the brachytherapy seeds were. It's actually a perfect situation for us to do stereotactic radiation to that area. And I put customized Barrigel spacing right behind that area to space the rectum away from an area that's going to get high intense focused radiation dose. That custom extra spacing in that area that Barrigel can provide, that allows me the ultimate ability to provide the best treatment for my patient. We use Barrigel for spacing for brachytherapy because of the fact that a lot of times brachytherapy is giving radiation over months as opposed to just a few weeks. It really has been a very quick learning curve. If you've done the prior hydrogel and did the dissection and know where Denonvilliers' fascia is in the past. This should be a very quick adaptation for that. Rectal spacing has always been critically important to protecting and improving quality of life after radiation. I've been in practice now for over 23 years. I've seen the evolution of what radiation has done, and it's been great from the standpoint of curing patients. But I've seen roughly about ten to twenty percent rate of rectal injury with prostate cancer treatment. With the use of rectal spacing and especially with the customization Barrigel provides, we have seen that number reduced down to maybe one or two percent of our patients having any sort of rectal irritation.

With Barrigel, I can see where each and every portion of this gel is going and ensure the patient is getting a safe and effective procedure. At Urology Austin, we work together very closely with the radiation oncologists, Dr. Garza and Dr. Pahlajani. Once they've decided on radiation, then our radiation oncology team actually has an incredibly beautifully built out pathway for those patients. So I'll often discuss with the patient the risks of therapy, radiation side effects to the nearby organs. We have to figure out ways to minimize dose to these critical structures while maximizing it within the prostate. The typical way of doing things was using a computer system, using a CT scanner to draw our targets, and bending and shaping the dose around the rectum, around the urethra, and the penile bulb. Invariably, we find that the urinary toxicity goes up since we've always had to prioritize the rectum. What's been a game changer is Barrigel, which is a spacing gel. And with the wide amount of space that's created, the rectum is no longer an issue. So it's our radiation oncologists who decide that an individual patient who's moving on with radiotherapy is a good candidate for rectal spacing. I have predetermined times on my schedule in which I do Barrigel on Mondays and Fridays. This helps them organize the placement of the Barrigel, the CT planning, as well as the MRI to make sure that the patient is able to get all of their pretreatment studies done in a timely and organized fashion. Placement of Barrigel is generally a pretty straightforward process, certainly for urologists who are familiar with this anatomy. I would describe the Barrigel placement similar to a transperineal biopsy. The setup includes putting the patient in a dorsal othotomy position, having access to the rectum, the perineum. The first step is to place the ultrasound in the rectum and we use a stepper as part of this which stabilizes the ultrasound. So we start with good visualization of the prostate and all of your anatomic landmarks using that ultrasound, you're comfortable with your orientation. And then with my process, we then anesthetize directly at the skin level, just using local anesthesia. And then we'll anesthetize somewhat deeper. And so I place local anesthesia along sort of the primary needle tracks that I'll be placing my needle for subsequent placement of the seeds and subsequent placement of the gel. Once the gold seeds or fiducials are placed, we then on aligning the prostate in the center of the ultrasound and following the needle directly over the ultrasound probe into the space between the prostate and the rectum. I tend to place it relatively first up higher towards the base or at least about two thirds of the way to the base. And then I make sure that I can see all the planes, the rectum, the fat plane, the Denonvilliers' fascia, the prostate, the capsule. After identifying that the tip of the needle is not in the rectum or the prostate and is mobile. We inject a small amount of Barrigel and look for this to balloon out in the axial view. We see a nice, very white hyperechoic area above and below that gel placement indicating we're neither too close to the prostate nor too close to the rectum. I confirm to see whether the gel is distributing properly in the midline or moving off to one side. Then if all of that placement looks correct, I'll typically back up little by little and place that in a column through the midline. We keep creeping back to the apex to ensure that the majority of the gel is at the apex creating a good amount of space. If it all goes exactly according to plan, the first syringe will be placed in the midline and then the second syringe gets placed on whichever the left or the right is most in need of further spacing and then the third syringe on the opposite side from that. After each syringe, we check both the axial and sagittal views ensuring that it's nice and symmetric and we sculpt as needed, meaning we move the needle tip into a different area or a different location if additional spacing is needed. At the end of three syringes we notice a very good even spacing and great protection at apex of the prostate. The apex of the prostate is typically where the rectum and the prostate are in closest contact and Barrigel is better able to create much more of a separation in a place that's very critical anatomically. Probably the vast majority of the patients have a placement that's, I'd say, perfect. One of the most important things is that we do not delay radiation. With Barrigel, it reduces the risk of any injury to the rectum or the prostate or infiltration of the gel in those areas. And because my visibility is very high quality and the ultrasound imaging is excellent throughout Barrigel placement, it really allows me to obtain sort of real time feedback from each little injection. With Barrigel, I can see where each and every portion of this gel is going and ensure the patient is getting a safe and effective procedure.

Patients with Barrigel have made the treatment planning process so much easier for me. You're just crushing these rectal constraints without even thinking about it. The physician is super happy with the results you're giving him, and you're doing this all in the first pass. When I evaluate a placement, I judge success by the amount of space that I'm able to create between the rectum and the prostate. So what the research has shown is that if you can obtain a minimum of a one centimeter displacement between the prostate and the rectum, that is the important endpoint that lowers the radiation dosage. This is a really good example of apical spacing. What you see here is the majority of the gel is centered around the mid prostate and apex and it allows for a significant distance between the apical prostate and the rectum. In one of these cross sections it measures as far as two centimeters which is just tremendous in protecting the rectum from radiation damage. It's really a teamwork approach to come up with the best plan for the patient. The dosimetrists and physicists are responsible for generating a plan as per my specifications customized to the patient's anatomy. A, what are we going to treat? B, what doses are going to be given? C, how long that treatment's going to be? And D, what technique to use? We have longer treatment courses and shorter treatment I first become involved at the time of CT simulation and once the patient comes in, one of our therapists will put them on the table and do the CT simulation with the whole idea of trying to put them in the same reproducible position that they'll be in for radiation treatment. We do send them off for an MR and we get a T1 and a T2 and we'll fuse that to the planning CT. Once I review them and do all the normal structure contouring, I send them on to the physicians. The physicians prefer to have those MRs present to contour the prostate because they can more reliably visualize the prostate on MR. MRs provide much better soft tissue. Brad Pollard and I work very closely as he is involved in every single patient that I treat. We can generate a pretty good plan because we are working together so often that they know what it is that I'm trying to achieve. Once they do their target contours, they give me some guidelines as far as how much dose they'd like to deliver to the targets and how much they would like to try and spare the organs at risk. And I work on treatment plans to try to satisfy those goals. Once that's completed and the physician signed off on that, we'll then get the plans ready to deliver that radiation. What I really find helpful with Barrigel is we're able to create space, which takes a lot of the hard work out of the planning because naturally the doses are low the way things are sitting. Generally with Barrigel we can get through a plan with spectacular results in one pass and on a plan where the hydrogel is not well placed, that could be two, three passes. And even then, you sort of have to say this may be as good as it gets. Also, one pass versus three, that's a fifty percent time saving. So in a typical day we can plan eight to ten patients with Barrigel and when we have patients that don't have a well placed hydrogel that might be three to four, maybe five patients. The time savings are significant. Spacing is something that's been around for probably since about twenty sixteen, twenty seventeen. The initial product was the spacer gel. The next kind of option out there that was the Barrigel. And Barrigel solved a problem where sometimes when you're putting a gel you don't have control of where is that gel going to end up. However, one of the things that Barrigel offers is the opportunity to control exactly where that gel is going, which really helps even more spare the tissues. So we're able to give higher doses to the prostate. I find the Barrigel applications to be more consistently high quality. Greater than ninety five percent of Barrigel patients have placements that I don't even have to think about, and I know we're gonna crush the rectal constraints. You don't have to spend much time overworking the plan to meet them. You're meeting them by a mile, and you're doing this all in the first pass. It's just made my treatment planning aspect of my job so much easier and so much more pleasant.

Barrigel allows a very real and improved element of control with placement, and I mean that from a couple perspectives. One is that because I can place Barrigel in a number of small injections or aliquots, it allows me to place the Barrigel first in one location and then learn from how the tissue responds to that. I can adjust my needle placement and adjust the gel injection in real time. And that control is also really improved by the excellent visualization that's allowed with Barrigel. And so Barrigel has no problems with through transmission of the ultrasound image. I can maintain that proper anatomic orientation throughout the entire delivery. Then the safety that comes with being constantly well oriented to the anatomy is a huge benefit from Barrigel. The fact that you have three separate syringes, the fact that you can clearly see your gel on ultrasound while you're doing the procedure in real time, it allows me to fine tune my implant. We're able to sculpt the placement of the gel, meaning that you can place a little bit extra Barrigel in one area, a little bit less in another, to allow for an even and symmetric lift of the prostate. One of Barrigel's very real world and legitimate benefits is that you can obtain that symmetry in nearly every placement. The data on Barrigel supports that assertion too. Believe it was about ninety five percent of the time that a high degree of symmetry was obtained from a Barrigel placement. What I found once I started using Barrigel is that I was more consistent in achieving the ideal implant. Pretty much every patient had great symmetry, nice placement of gel from apex to base, and a very good separation. And that's pretty impressive. Rather than making one single decision, Barrigel allows me to obtain sort of real time feedback from each little injection. And so I place the needle. But then at that point, I only inject maybe half a cc of the gel, and then I pay attention to what is the tissue response like. The fact that you can see the gel as it enters, you don't have any loss of ultrasound imaging. As you're deploying your syringe, if you see any in the serosal wall, you'll stop, pull the needle out and reposition. And I think that's why when you look at the data across many different users, ninety nine percent of Barrigel cases avoided rectal wall infiltration, which was much better than our competitors. There's significantly more control with Barrigel placement than SpaceOAR. With Barrigel, it doesn't polymerize or get stuck or get hard. You can take your time and exact good precise control to allow for a symmetric and significant lift of the prostate up and off of the rectum. I try to place the first of three syringes of Barrigel. I place that whole syringe relatively in the midline, and then the goal of that step is to learn from that initial placement. So is the tissue separating properly? Is the resistance to the injection feeling correct? Is it distributing correctly in the midline? If you're satisfied, that's terrific. But if you're unsatisfied, perhaps at mid gland or at base or at apex, then you'll concentrate more gel there with your second and third syringe. There's no question about it, since I began using Barrigel, it's been a game changer. I've basically entirely switched to Barrigel, and I think the reason for that change is born of sort of two major reasonings. So one is my own personal experience, having used a lot of spacing before Barrigel and having used a lot of Barrigel since then. But then it's also born from the clinical trials. I'm a researcher, so it would be against some unspoken rule for me to ignore the data on that topic. You know, that combination of good clinical trial work and good personal experience really is what has caused me to shift entirely in the direction of utilizing Barrigel.

One of the things that I'm really excited about that I've translated into my practice is the improvement of outcomes in prostate cancer using radiation therapy with higher and higher doses. But up till now, there have been limits in being able to do that safely. Ideally, we want to deliver as much of the desired dose as possible. But when we don't have the spacing we need or would like at the apex of the prostate, ultimately it's like the old days where we're making sacrifices to the plan in order to ensure that the rectum doesn't go over tolerance. I feel like Barrigel brings a lot to my clinical practice. A lot of advantages, the ability to control the placement of the gel in a way that is not possible with other technologies. I'm able to drop higher doses where I want, yet know that there is a big margin of safety. One of those approaches that I'm really excited about now is using something called a Micro Boost. And that's using a higher dose of radiation directed to specifically the area of the most bulky involvement that you can see on imaging. Some of our patients have nodules within the prostate that we're delivering upwards of one hundred and three gray, a much higher level of radiation than the entire volume gets. Depending on where that nodule is, and sometimes they're more posterior, having a product like Barrigel, keeping that rectum far away allows us to do something like that safely. One of the things that I use to evaluate how effective something is, is looking at randomized clinical trials. In looking at the pivotal trial data, I think clearly shows that patients with Barrigel are much less likely to have any, acute toxicity. The other thing that the pivotal trial data shows is that there's an increased amount of space with Barrigel and it's preserved even at three months after the placement. So when I look at the results that we've achieved with Barrigel, looking at the plans that we're able to generate, certainly looking at the criteria that I'm trying to meet, we're really blowing way past anything that are the metrics that have been out there for decades. Barrigel has allowed us to use higher doses of radiation to the prostate safely. Prior SBRT trials before spacing had a lot of complications and side effects. However, with Barrigel, we're able to protect the rectum from radiation damage while still delivering a significant amount of radiation to kill the prostate cancer cells and get a better treatment for the patient. And I'm looking at the way my patients are tolerating radiation therapy with Barrigel. And I think that they're tolerating treatments very well. Most importantly, when it comes to applying some of the latest data out there that show higher and higher doses of radiation make a critical difference in controlling the prostate cancer, It's showing in the results as well where my patients are having better outcomes than I've seen before.

There's some hesitation for new users to use Barrigel in that they think they won't be able to see the gel on CT planning. I think once a user has some more experience with Barrigel, it's so easy to identify in CT. There is a way to change your window leveling on CT planning. And with that, you can clearly see the product very well. Within two or three cases, everyone feels very comfortable in contouring the images. So definitely looking at your window leveling is going to help. Having it on soft tissue is going to be the most difficult because Barrigel is soft tissue equivalent. So it doesn't stand out in that window level well. However, if you switch the window level presets to either cerebellum or liver, that tends to give a little more depth of contrast so you're able to see the border better. I think Barrigel is clearly visible on CT scans. But having said that, the tools that we have nowadays and the newer planning systems are very robust. The older planning system might lack settings on their grayscale, but that could be circumvented by doing a tighter slice CT during simulation, thus allowing the older planning systems to have better visibility. Most standard CT planning packages have that ability to change your window levels so that you can see the CT in different ways. And by changing the leveling, can certainly see the spacer between the prostate and the rectum. As far as the visibility of Barrigel, I feel like we're able to see it well. There's a little difference in density between the Barrigel and the surrounding tissue. And you could see that on CT, comes, it's a little darker. The more you visualize Barrigel, the easier it is to see. So Barrigel, I think of it similar to contouring the esophagus for, dosimetry that you can't see the esophagus on every slice. However, you know it is a predictable track of where it should go. So you go to the slice you can see superior, go to the slice you can see inferior, and then interpolate. In general too, we found the best practice is to contour a continuous piece for the Barrigel and not want to break it up into little small individual contours. When you look at the ultrasound insertion of it, can see that product is there through the entire track. So even if you can't fully see it on a single slice, you should have some confidence that it is in between as well in a uniform shape. Any particular clinic has issues viewing the Barrigel on the planning system, one go to is the thickness of the CT slices. The spacing of the actual slices on CT are different from clinic to clinic. So one millimeter slices are ideal. Most people do three. If you have the latest software for the actual simulation and planning system, three is okay. But if you have older equipment, you want to decrease the slices to one millimeter. And on an Eclipse system, using the cerebellum window leveling preset is what has given the best scenario to see the Barrigel. I think once a user has some more experience with Barrigel, it's so easy to identify in CT. But perhaps new users will spend a little bit more time changing the window level to properly identify it. But within two or three cases, everyone feels very comfortable in contouring the images after the implant.