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David Staskin: Welcome to UroToday. I'm David Staskin. I have a real pleasure and a privilege today to discuss stress incontinence surgery and vaginal slings with Dr. Ariana Smith. Ariana is the Alan J. Wein professor of urology at the University of Pennsylvania, and the chief of urology at Pennsylvania Hospital. We do share some heritage, though. I was Alan's first chief resident.

I also graduated from Cornell, where Ariana did, although decades earlier, I assume. I was a resident at University of Pennsylvania and did my fellowship training with Dr. Ross. I was number seven. Do you know what number you were, Ariana?

Ariana Smith: I think I was 55.

David Staskin: 55. That just tells everybody all the math they needed to know. She has a wonderful pedigree, greater than 150 publications, a principal investigator for NIDDK and the PLUS National Bladder Health Study. Treasurer SUFU, co-chair for the bladder guidelines on the exam committee. And so we're going to get a chance to question Ariana a little bit now for those of you who've taken a board exam with her.

And we'll let her present her information first, and then we'll come back for a really good discussion. Ariana.

Ariana Smith: Thank you, David. I'm going to go ahead and share my slides. It's really a pleasure to talk with you today about the autologous pubic vaginal sling. This is such an important topic for us to discuss because despite the procedure being around for over a century, many women, when being counseled on the options for treatment of stress urinary incontinence, never hear about the autologous sling.

The autologous vaginal sling is used to treat stress urinary incontinence, which is defined by the International Continence Society as the involuntary loss of urine with physical exertion, coughing, or sneezing. There are four surgical treatment options supported by the American Urological Association clinical guideline.

And although the four options are not equivalent in efficacy, according to the guideline, they can all be considered to treat an index patient with stress urinary incontinence. So why are we highlighting the autologous sling today? Because we're looking to showcase a procedure with the durable, lasting effects seen with all slings, compared to bulking agents and retropubic suspensions, utilizing a mesh-free alternative.

The autologous sling has been around a lot longer than the mesh sling, but the minimally invasive nature, simplicity, and the high success rates of the mesh mid urethral sling led to diminished use of the autologous sling over the last two decades. But with ongoing controversy over vaginal mesh across the globe, there is renewed interest in a non-synthetic durable option like the autologous sling.

So let's get into how we do it. The autologous sling utilizes the patient's own fascia, which can be taken from the fascia overlying the rectus muscle, as shown here, or from the lateral thigh, which is referred to as fascia lata. Regardless of location, the fascial strip is marked out at approximately 1cm to 1.5cm wide by approximately 8cm long.

The fascia is harvested by freeing it from the underlying muscle, as shown on the left, and then the fascial defect is closed in a running fashion with care to prevent dehiscence and herniation. Generally, autologous slings are placed in the retropubic position as shown on the left panel, essentially forming a U of support under the urethra with the arms of the sling extending into the retropubic space on each side.

The original description of the autologous pubic vaginal sling was placed-- it was placed at the level of the bladder neck. When the mesh mid urethral sling was developed, it was designed for placement at the mid urethra. The high success rates and most notably the low voiding dysfunction rates of the mesh sling led several surgeons to rethink positioning of the autologous pubic vaginal sling, with many, including myself, moving the placement to the mid urethra.

The harvested autologous fascia is placed under the vaginal wall at the level of the mid urethra. Creating a 1.5cm tunnel under the vaginal wall, as shown here with the right angle clamp, allows very precise placement of the fascia at this mid urethral location without concern about proximal or distal migration. Sutures are placed on the ends of the fascia to facilitate passage into the retropubic space.

These can be absorbable sutures. They could be permanent sutures. I favor prolene. The sling is positioned under the urethra, and the sutures on the end of the sling are then passed behind the pubic bone using a needle passer, and the sutures are secured above the rectus fascia. The fascial sling then takes the shape of a U of support under the mid urethra, extending on both sides into the retropubic space.

The sling is not compressing the urethra, and it still allows for volitional voiding without obstruction, but during times of coughing, sneezing, and physical activity, it prevents leakage from occurring. We could spend the whole day pontificating on why the autologous pubic vaginal sling works for stress incontinence, but I think the main point is that not all stress incontinence is the same.

There are several potential contributors to the development of stress incontinence. And the autologous vaginal sling does a great job addressing several of the proposed pathophysiologic mechanisms. It can prevent hypermobility. It can provide some tissue bulk in the periurethral space. It can cradle the urethra, providing a backboard during increases in intra-abdominal pressure, and it can create vectors of force, supporting the urethra.

And it can restore support when ligaments have been damaged. So how effective is it? This study, designed in the early 2000s, was a multicenter, NIH-funded, randomized controlled trial with 655 participants. Two years post-surgery using a very strict definition of success, essentially being totally dry from any incontinence, the autologous fascial sling provided a 66% cure rate.

Whereas if you look at treatment satisfaction at 24 months, it was 86% effective. So how does this compare to the mesh sling? In a patient preference trial, 201 women were offered either a fascial sling or a mesh sling. 91 chose fascial. 110 chose mesh. At a median follow-up of 13.8 months, the dry rate was 75.8% for fascial slings and 80.9% for the mesh sling, and this was not statistically different.

There was comparable voiding difficulty and comparable complication rates. So the authors of this study concluded that fascial slings may safely be offered to patients concerned about implantation of mesh. So, David, I end with the opinion that there is no perfect procedure for the treatment of stress urinary incontinence. You need to weigh the risks and the benefits of the various treatment approaches for each individual patient.

But the autologous vaginal sling should certainly be offered to women as a mesh-free, durable option.

David Staskin: Excellent, Ariana. And thank you for that nice presentation. Do you still do a mesh sling at all in anyone?

Ariana Smith: I do. I definitely--

David Staskin: How do you decide?

Ariana Smith: How do I decide? Well, I offer all patients unless there's a reason not to offer. So for example, the patient who came in with a mesh complication that I took care of and now needs a new sling. I tend not to offer that specific patient another mesh sling. But for any index patient who comes in, they hear both options, there are certain patients who undergoing an autologous sling with an abdominal incision, it's just not in the cards for them.

They've only got a week off from work. They need to be picking up their kids, driving them all over town. I think those patients, a mesh sling is just going to fit in their life better. There are also concerns about people with autoimmune disease or who really do fear mesh. They know someone, a family member or friend, and it's just not for them.

David Staskin: So based on outcomes and your knowledge and you're comfortable either way, and you'll actually let the patient decide unless there's a medical or surgical reason why they should go with your suggestion.

Ariana Smith: Yeah, I think that's the beauty of having both in the toolbox.

David Staskin: All right. Excellent. What about evaluation? Because we didn't talk about that in your presentation. Urodynamics for everyone with primary stress incontinence.

Ariana Smith: Absolutely not. I think we learned from the VALUE trial that it's not cost effective. It's not necessary. It doesn't change our outcomes. I think there are a lot of patients who need it, don't get me wrong. And a lot of patients in my practice end up with urodynamics because they have a much more complicated picture than simply walking in and saying, hey, I leak a little when I cough or exercise or sneeze.

It seems like every other patient perhaps has something else in their story. Oh, it's a little bit hard to pee. I have to lean forward and lift my left foot, and then I can urinate. And I hear those stories, and I worry what slings may do. And I certainly do get urodynamics in those situations.

David Staskin: I would agree with what you said in your presentation, although you said that your preference was to move from the bladder neck to the mid urethra. I do think the bladder neck slings, regardless of how they're done and especially the pubovaginal sling, I trained and went into practice when this was much more popular, the pubovaginal.

And it always amazed me as to how obstructing it could be at the bladder neck in some women. And I always sort of struggled. And I had a question for you. If you were going to operate on someone and do a pubovaginal sling, and you had the choice between someone that had a greater than 20cm of water overactive bladder, if they squeezed, you could see the pressure go up.

Or if you had somebody with relatively-- well, moderate to severe ISD. Or you had somebody that had a PVR and although it was sort of unexplainable, you tried to get a pressure flow study. It didn't look like there was much of a bladder contraction. I don't think I would ever do a bladder neck sling on that person anymore, but I might do something at the mid urethra.

Ariana Smith: I completely agree with you. This is the art of what we do, right? It's not the science. I wish there were more science sometimes. But the art of what we do is finding the right position, the right sling, the right surgery for the right patient.

And I think when we take the time to find those details that you just explained, right, the patient who is leaking from overactive bladder at a certain pressure, the patient who's already having a little bit of a hard time voiding, when we really dive in to their symptoms and how they're urinating, we really do a better job selecting and then optimizing treatment for each individual patient.

David Staskin: All right. So you have a mid urethral preference and a rectus fascia rather than thigh preference. I know there have been some reports about some problems, leg problems after the harvesting of fascia from the leg, especially with the fascial stripper. Would you recommend it, though, if someone had, had a previous abdominal surgery, and they wanted to avoid mesh? Have you harvested from the leg?

Ariana Smith: Yeah, I have not a lot of experience harvesting from the leg, but the experience I did have, some patients were unhappy with that lateral bulge that can occur. I wouldn't advise against it, however, and I do think there are some situations where it makes a lot of sense. Number one, if a patient doesn't want an abdominal incision.

Number two is if you need more fascia than what you can gain from a rectus fascial harvest. You are limited with the rectus fascia on how much you can safely take, whereas you can get more from the lateral thigh. So if you were also going to do an autologous sacral colpopexy at the same time, and you really needed more, I think the thigh is the right approach for that patient.

David Staskin: Excellent. Let's talk about post-op and the patient that's not voiding, if it's a mid-urethral fascial mesh-- I mean a mid-urethral mesh sling, I would say if they don't follow you within a week, we're going back and we're going to cut it because your chances of getting better are small. If you move from the bladder neck to the mid urethra and you have delayed voiding, what do you do with retention or poor emptying?

Ariana Smith: Yeah, so that's a great question, David. I think if it's mesh, I intervene early, like you mentioned, around a week or two, assuming they haven't had like a major prolapse repair at the same time, and they're not having trouble with pain and constipation.

But if it's a simple sling, and we're a week or two post op and they're not voiding, and it's mesh, I'm cutting it because mesh continues to contract during the healing phase and it really should only get worse, not better. Whereas the autologous sling, that's completely not the case. We expect, with a little time, the autologous sling could actually loosen.

Now, I mentioned, I use prolene sutures. A lot of people use PDS or vicryl and in those situations, I think, you have even more of a chance of it potentially loosening during the healing phase. But even with the prolene sutures that I use, if I've waited this out four, six, eight weeks, most patients get better. It's extremely rare to have to intervene and have to go in and do anything after--

David Staskin: Yeah, I'll vote with you on prolene sutures, but it leads to another really interesting question. Vicryl probably retains its-- it's probably around for maybe four to six weeks if you really looked for it under a microscope, but it's really lost more than 50% of its holding ability by two to three weeks.

How does the sling work if all you have is a piece of non-vascularized fascia poking through on each side, sort of dangling there from two vicryls that after three or four weeks aren't doing anything anymore? I'm a prolene person, like you. I like it to, quote unquote, "heal into place." But even the prolene suture pulls out of the tissue.

So how does the sling stabilize things so after we're through this two month, three month period, they all don't fail?

Ariana Smith: Yeah, because they don't fail, right? I mean, they do--

David Staskin: They don't by experience. But I mean, if we're going to hypothesize something, I mean, you showed all of those things that the sling does. I can see that the bulk might still be there, but it's going to be absorbed. I can see that it makes this form of support, but that's not going to be supported from above after a few weeks. So why does it work?

Ariana Smith: Yeah, it's a great question. I think possibly what's going on is we're dissecting a space. We're creating enough space to place that tissue in it. And then, essentially, scarring takes over, right? And the body scars and it forms a nice firm ligament-like structure in the area where the scar forms, and this helps to prevent the hypermobility of the urethra, provides a little bit of a backboard. Wagering--

David Staskin: I agree with that 100%. I don't know that we ever really get to see, even if you're in from above for another reason, and you had an opportunity to look at someone that has a sling. In a mesh sling, you can't really find the mesh.

You know it's there, but it's sort of, I think, stuck up against the back of the pubic bone so it holds in place long enough to heal, and that the fascia also heals up as a, quote unquote, let's just say "new tissue," rather than scar. But it really forms new tissue lateral to the pubic urethral ligaments. And I think that's the most interesting part of not taking a whole piece of fascia.

So going back to what you cut off the rectus muscle, is there too little or too much or just right? When you measure it, how do you decide how long your piece is?

Ariana Smith: Yeah. So I did put some approximate dimensions in my presentation. I think I said 1 to 1.5 wide and about 8 long, but it does depend on the patient. You have some very narrow pelvis women who if you take an 8cm strip, you're really going side to side all the way, and you're putting them at risk for potential wound dehiscence, fascial dehiscence, even herniation if you take too wide of a strip.

So I think it can be too wide. And I think you do run the risk of potential complication. Can you be too small? I don't know. If you think about the theories we just played around with there on how it works, it probably doesn't matter so much how long it is, and maybe we could get away with much shorter harvests--

David Staskin: If you had two anchors and two sutures, and you went lateral like it was a mini sling, and you ran a piece of fascia across, do you think it would work?

Ariana Smith: I think it would probably work. I do worry sometimes with those anchors in mini slings if you didn't quite position it just right, is that really going to hold up over time? Because certainly I've seen patients who've come back, and they have material kind of wadded up in that vaginal space. And what happened is the anchor didn't hold.

So I haven't been a big adopter of the mini sling for those reasons. I see a lot of patients brought in from the greater Philadelphia area when things go wrong. And I think it does influence what you choose to do when you've seen some of those things go wrong.

David Staskin: Let's talk about some other interesting things that we've probably both seen a fair amount of, either suture in the bladder or for me it would be more of my referrals might be for mesh. Occasionally, I'll see somebody that had a pubic vaginal sling, and there may not be suture in the bladder, but there's a sort of calcified area laterally down by the base, which I presume was the fascia coming through and either dissolving or calcifying a little bit.

Do these things erode in or are they put into the bladder at the time of the surgery? A lot of times don't see the patient for a year. So they've had recurrent UTIs and a little bit of hematuria. Someone finally does a cystoscopy. Do you think there's less of a risk with the-- they say that the mesh erodes in. I don't believe that.

I believe it's put into the bladder at the time of the surgery. How do you feel about that? And do you think there's an advantage for fascia because you think it's softer?

Ariana Smith: Yeah, I agree with you. I think most of the time when you discover a mesh complication, especially within a year of surgery, I think it was probably placed there. And unfortunately, the cystoscopy that I think everyone supposedly does may have missed it. And I've definitely seen this with urethral mesh where the cystoscopy, it just went right by the urethra, and they completely missed the urethral mesh exposure.

In the bladder, it's probably your needle passer that's creating the issue. Your needle passer went through the bladder, and then you missed it.

David Staskin: What about other materials then, other than fascia? We're not going to use mesh. And we're not going to harvest fascia for someone's had multiple surgeries, and they really don't want anything taken from their leg. Are you using any other materials at all and doing the same type of surgery?

Ariana Smith: Very rarely. Very rarely. I think there's now been enough studies done from various groups showing that these other biologics are not as durable, and they don't stand the test of time. I'm not sure what happens to them in the body, and I don't know why exactly the autologous sling is different, but it does appear that the data is different.

David Staskin: Yeah, I mean, there's a lot of use of dermis and pericardium and other sorts of tissue. I don't think anything's worked as far as a non-mesh, as well as the autologous fascia of the patient. And the cadaveric fascia had problems with processing and freeze drying and breaking the collagen bonds and therefore, it sort of got absorbed more quickly.

Let's talk, at the end here, just a little about one last technique question and something I noticed that you did. And I don't know if it's from during your fellowship training or not, but you make two incisions in the vagina instead of one midline incision when you do this operation. It's one of your own little-- put your initials on the slide, not on the patient, but you can put your initials on that because I don't see that often anymore. Is there a reason?

Ariana Smith: I may have created it in my own head this reason, but when I'm talking to patients about it, I tell them that I'm moving their incisions lateral out of the midline, away from areas of high friction during intercourse to decrease their risk of discomfort post-operatively with intercourse.

David Staskin: You mean where the vaginal incision would have been?

Ariana Smith: Yeah, it's probably one of the things--

David Staskin: --besides. Yeah. I wasn't with Dr. Ross when he started to do his sort of mesh sling, but when he developed that, he used two lateral incisions instead of one midline. And all of us who do a lot of vaginal surgery realize it's not that hard to get out laterally one way or another, but I never liked putting the mesh-- if a risk of mesh coming out with one incision was 2%, 3%, I never understood why you'd make two incisions and risk having a flap that would become ischemic with mesh under it.

Listen, Ariana, this has been great. I really appreciate you joining me and your honesty and insight on a lot of these things. I'd like to thank UroToday. They've really provided a forum. And I think we spent a lot more time discussing things that if urologists are watching this, that if you want to know how to do a pubovaginal sling, you can learn that on YouTube.

But if you want to learn how Ariana Smith does one and why, you have to go to UroToday. So thank you very much for joining me.

Ariana Smith: Absolutely. My pleasure, David. Take care.

David Staskin: Have a great day.