Jim Hu: Hey, Zach, thank you. I'm delighted to speak to UroToday, as always.
Zachary Klaassen: You've got some fantastic slides, a lot of visuals and videos, which I think is perfect for this conversation. So why don't you go through your presentation?
Jim Hu: Great. Thank you so much, Zach. So basically we know that the traditional nerve sparing, particularly with a retropubic approach during open surgery and now robotics was predicated on opening the endopelvic fascia, finding that anterior contour, and then teasing off the neurovascular bundles, which Dr. Walsh in 1982 described as being posterior lateral or like the face of a clock at 5:00 and 7:00 o'clock. In terms of the outcomes of nerve sparing, I think these population-based studies with patient-reported outcomes with validated quality-of-life instruments really give us a good flavor for recovery at 12 months, ranging from 0% to 40% depending on the surgeon who you have surgery with, versus, as you can see at two years, a little better than 0%, but topping out at 43%. And then we've also seen a nice study from a tertiary cancer referral center, which looked at patient-reported erectile function recovery rates over almost a decade, and we can see that in the blue line, that number in terms of recovery is less than 20% at one year and at less than 30% at two years, and it hasn't improved.
And so again, using that technique that I said, I think most of us, we do define the posterior contour during robotic-assisted surgery, but we use the anterior contour, for example, to figure out where to take the lateral pedicle, and then in an antegrade largely fashion, do the nerve sparing. The posterior approach or PATENTS, as you mentioned earlier, is a little different in the sense that we follow the posterior contour alone. We don't open up the endopelvic fascia or split the lateral pelvic fascia, which we know that there are autonomic nerves underneath these different layers, or this red arrow denotes perhaps where someone would traditionally make the incision in the periprostatic tissue and then to save, as I mentioned earlier, the posterior lateral neurovascular bundles, whereas you're going to preserve all of this tissue or leave it without the specimen, which usually has that tissue on there if you don't do a posterior approach. The other benefits, we know accessory pudendal arteries, for example, run underneath the endopelvic fascia, so then you don't have to worry about that or dissect those, spend time dissecting those out. As many of us know, there are these large capsular veins. And so when you make that anterior lateral entry, oftentimes the distribution of those veins is variable and you get into venous bleeding. Whereas again, with this posterior approach, you can oftentimes get underneath them and preserve those veins. And so I should say here that there hasn't been a comparative study that has demonstrated an improvement in this type of nerve sparing.
In truth, we know that everyone differs a little bit in how they do nerve sparing, but certainly, for example, the Retzius-sparing approach would have a similar nerve sparing approach, but there hasn't been shown to be improved erectile function recovery, although urinary function has been shown to be better. In terms of the postoperative appearance, when you save more of that anterior lateral tissue, you see that there's more of a cave effect, whereas this has the appearance of what I say is like the hull of a boat. And previously when we opened up the endopelvic fascia, we always talked about the train tracks or the saving of the neurovascular bundle. And that accompanied, I think, when you overdissected the lateral aspect of the bundle, which you don't need to do. Here we have our video demonstration where we're starting on the right side. And as you can see, we've defined the posterior contour of the prostate. We're pretty posterior here. As I said earlier, we haven't opened up the endopelvic fascia. We're going in an antegrade fashion. I avoid the use of clips. I've avoided the use of clips for some time. In terms of when did I start this approach? I'd say it was about three years ago, and we'll take a look at some of the data a little later. But again, I think that the key point here is, and you'll see it as we zoom back a little bit right there, that the endopelvic fascia has not been opened. I am running into some of these capsular veins and you'll see little arterials that I use pinpoint bipolar cautery on. And so the other relevance of the technique in this particular case is that this is a 68-year-old gentleman with a relatively large prostate, I think it was about 150 CCs. And so we know that, for example, nerve sparing is a little bit more challenging with bigger prostates, and there's also questions of whether or not erectile function is worse in men with larger prostates, I think because of that mass effect, and potentially there being more trauma when you dissect out these bigger prostates.
So we're getting closer to the apex now, but as you can see, everything has been done thus far, and that's a good backup or larger shot where you can see the endopelvic fascia has not been opened whatsoever. And now we're just coming around on this more in an anterior fashion. Now, with these bigger prostates, I do, if you will, take the endopelvic fascia a little higher just because otherwise the exposure would be very difficult if everything was behind it. So for purposes of time, let me just skip ahead just to show a little bit. So now we're on the left side, just to show things completely, but very similar. We're using the pinpoint bipolar cautery there. You can see we're using a little blunt dissection. And again, we're just following this posterior contour all the way around. And again, the endopelvic fascia, you can see there has not been opened. Let me just go on to the next slide. So in terms of the study, this just gives you a sense of what the exclusions were. These were consecutive radical prostatectomies. As I said earlier, over the past three years or so, this was the PATENTS or posterior approach. At baseline, we only included men who completed an EPIC-CP that checked off these two categories.
That is they either had erections firm enough for intercourse or they had erections firm enough for masturbation, foreplay only. And the reason for this exclusion is we know is as people get older, as men get older, the likelihood of ED gets higher. So we wanted to make it generalizable. This left us with 278 anterior versus 217 posterior comparisons. Just really briefly, you can see of relevance, and again, this is almost over a 10-year period, but we can see that over time we're operating on older men, on average two years older, also just less grade group one with the greater adoption of active surveillance. And I didn't show it here, but I did full nerve sparing in roughly a little, approximating 95% of patients, just personal preference. And then in terms of the unadjusted curves in terms of recovery, this is men who at baseline had erection firm enough for sexual activity. I said earlier, it's a combination of either firm enough for masturbation, foreplay only or erectile function for intercourse. And so again, you can see even with the fact that in the denominator, we have people that didn't achieve erections firm enough for intercourse. There's a striking difference in the unadjusted curves, and with the caveat that these men are two years older.
This is now looking at, if we took the men out who didn't have erections firm enough for intercourse at baseline, you see that the unadjusted curve in the green for the posterior approach gets a little higher, approximate 70%. Looking at different definitions, this is now sexual activity or better than inclusion of those two categorical answers. This is now for anyone who said they had partial erections, and the partial erections did not have to be firm enough for sexual activity. But the bottom line is across all of these different definitions, the unadjusted P-value showed a significant improvement with the PATENTS approach. And then in the multivariable analysis, we can see that your traditional factors that work against recovery of erectile function, for example, older age had a detrimental effect, higher body mass index had a detrimental effect. There was a learning curve, if you will, if we looked at consecutive case number as a variable. And then most strikingly, there's a more than twofold adjusted improvement in recovery of erectile function. And so these are the conclusions, which I would say again, we aim to preserve more of the anterior lateral periprostatic tissue and the adjusted analysis showed a more than twofold improvement in erectile function. So let me stop screen sharing right there.
Zachary Klaassen: Jim, fantastic presentation. And I love the visuals, because I think that really helps our listeners see what you're doing. And I think when you look at, you've got good numbers, you've got over 200 patients in each group, and you've clearly shown even at three months, you're seeing a split of those curves. When we talk to these patients about radical prostatectomy, we talk about incontinence, we talk about erectile function. Looking at these numbers now in your practice, how has this changed the conversation with your patients preoperatively?
Jim Hu: Absolutely. So I always try to, I think, and you of course do this a lot and know about patient regret.
Zachary Klaassen: Yeah.
Jim Hu: And so I always try to under-promise and over-deliver, right?
Zachary Klaassen: Yeah.
Jim Hu: Because I think difference, regret is when what happens in real life doesn't meet what the expectations you set. And so basically I do tell them, as patients get older, for example, the likelihood of recovery of erectile function is worse. Of course, your baseline is important. The men who are really fit, close to ideal body mass index, they work out a lot, that certainly helps. But I certainly tell men, like previously, I would say I didn't tell men over the age of 70 that there'd likely be recovery of erectile function, but as we get a larger sample size, that's something that we're going to tease out, that is there an interaction effect between age and better recovery of erectile function? So that's how I would say that the counseling has changed. I think finally, just to put a finer point on that, I think if you're a high-volume person, you've done a lot of these, you don't really spend a lot of time talking about bleeding, or the need for transfusions, or urine leaks. I think it's mainly the focus is on recovery of erectile function. Incontinence, as we've shown before, with fascia-sparing is pretty good.
Zachary Klaassen: Yeah, absolutely. I think just looking at this, and we've seen Retzius-sparing come into view in the last few years as well, this seems like it's got a shorter learning curve. Would that be fair?
Jim Hu: Yeah, I would say, yes, the hood approach, when you're coming from above where I think most of us traditionally are accustomed to during radical prostatectomies, you have more space, and I think you can always bail out. With Retzius, you can certainly bail out, but as you know, everything's done through that posterior cul-de-sac and it can appear a little crowded, especially in the case of a larger prostate like the video that we showed.
Zachary Klaassen: No, absolutely. Jim, great presentation. Anything we haven't hit on you want to share with our listeners, any take-home points?
Jim Hu: No. Well, listen, Zach, I think that's it. Delighted to talk to you guys as always, and thanks for the opportunity to showcase our work.
Zachary Klaassen: Absolutely. Happy to do so, Jim. Thanks so much for your time on your UroToday.
Jim Hu: Hey, my pleasure. You guys have a great day.