Chapters Transcript Improving the Botox Experience Course: Urogynecology and Reconstructive Pelvic Surgery Um, I'm gonna spend the next 20 minutes talking a little bit about the mini sling. Um, and here are my disclosures. And I think it's really important when we think about a new device or technology to really understand the history about where we came from, and we can learn a lot about the current time based on sort of looking back into the past and learning from the lessons and the trials of our previous attempts to to do something, so. If we look back, treating stress incontinence has been something that has been constantly in full evolution, starting in the early 1960s with retropubic copal suspension and pub vaginal sling. And these procedures um were effective but fairly invasive, and they did come with a lot of side effects and treating stress incontinence for a woman in sort of a minimally invasive and outpatient basis was a little bit hard during this time. After these two procedures came the retropubic needle suspensions, and it was really an attempt to make a less invasive option available for our patients. But unfortunately, these procedures were not effective. So in the early 1990s come along the retropubic mid-urethral sling, which was a game changer for most people's practices, and that it was minimally invasive with really good efficacy. And several years later, 90% of surgery for stress incontinence worldwide were these procedures. And then several years after that, um, in order to avoid the retro pubic space, the trans operator mid-urethral sling was developed. And this, you know, overall there's lots of good data and lots of good studies supporting both of these procedures, but as time went on, people started to wonder if there was a way to develop a sling that would avoid both the retro pubic space and the terrain. Trader frame and so in come the initial single incision slings. And so in 2006, the first models of the single incision slings came to market, and this was largely the TBT secure. And for anyone who practiced during that time, they might have been familiar with this device, and unfortunately, this device did have poor efficacy. There's some data that I'm going to present on 2017. Um, Cochrane review, which took a look at these early single incision devices, and it was a very good Cochrane review with 31 studies that were randomized or quasi-randomized, and they included any trials that had women with stress incontinence or mixed stress incontinence that was uh mixed incontinence stress predominant, and at least one of the arms had to involve in single incision sling. And what they concluded was that the TBT secure, which was largely again the sling used at this time, was inferior to the standard mid-urethral slings for the treatment of women with stress incontinence, and actually by the publication of this paper, the device had been withdrawn from the market. And so that leads us to now where we are in current present day where there are. We are seeing a resurgence of the mini sling and new devices that have come to the market, and largely the difference, and we'll go over some of this in a little bit, is that these devices for the most part, are able to be tensioned after the anchors are deployed, and we'll we'll sort of review that a little bit in detail and talk about what the mini sling landscape looks like now with these new devices. So a little bit about definitions and sort of defining what a mini sling. is in a mini sling and a single incision sling are in fact the same exact thing, just different terms to call the same device. And the single incision sling differs from full length slings in two ways, and that is 8 centimeters rather than the traditional longer 40 centimeters, and it requires only vaginal incisions. Those are sort of the definitions and criteria that studies look for when they're including um single incision slings in their analysis. And there are really two available variations based on the anatomic path and the site at which the ends of the sling attach. Retropubic is in a U-shaped position very similar to a retropubic sling in the connective tissue of the urogenital diaphragm, and the transoperator approach is a more of a hammock or an H type position, which you can see right here. I don't know if my pointer is showing up here. Yeah, uh, there we go, should be. Still not showing up, but it's the last picture there that you can see, um, on the side. And so just a little review of surgical technique, um, that we'll go over as some of you may not be familiar with these in their practice, since they are new, especially the ones that require um or allow you to tension after the acres are deployed. Um, this is taken from a video published recently this year, um, in the Journal of Minimally Invasive Gynecology. I'm not gonna show the video, I'm just gonna show some highlighted pictures of parts of the technique that I think are important. Um, so the technique begins similarly to any um mid-urethral sling where you begin at the, um, mid-urethra, um, marking that with Alice clamps and then injecting, um, a dilute vasopressin or lidocaine 1% with epinephrine, um, at the midline, as well as the perurethral sulcus. Um, and this becomes important in the mini sling to help prevent any exposure in the mid-urethral sulcus and create a nice dissection in that area. Um, you're gonna incise in the midline with a knife, very similarly, how you begin any sling, and then make your paraurethral dissection out to the inferior pubic ramus rami. When you're um setting up your mini sling, you are going to position your anchor and for this particular device, it's very important that you position the tip of the trocar sort of um past the tip of the anchor. And for trocar placement, you're gonna be placing this trocar at the 10 o'clock position at the inferior pubic rami, and they describe a technique um for deployment of this particular sling as an end, meaning putting the sling into your perurethral sulcus, pushing up to elevate, and then over into the operator complex. Once your sling is deployed in the operator complex, you'll hear a pop, where the anchor um gets placed, and the anchor that you place first is sort of the static anchor, the anchor that does not move. And then you want to make sure that the sling is relatively positioned in the midline, with the midline marker no greater than 2 centimeters to the left of the midline. After you do your first sort of static anchor placement, you repeat the same procedure on the other side where you deploy the dynamic anchor, and you begin to tension. And so I'm going to show you a picture of how these slings are tensioned differently. Um, and so, in order to tension the sling, you pull on the proline stitch, which keeps, again, your, um, sort of, let's see if I can get this pointer working. Let's see, laser pointer. OK, great. Um, which keeps the sort of static anchor fixed, and then this dynamic anchor acts as a pulley to go ahead and pull your sling into place. And so this is again a difference from the slings of early 2006 and 2007 where they sort of had no ability to adjust the sling once the anchors were deployed. Now many of the slings on the market are do allow for post deployment uh adjustment. And then you close your sling very similar to how you would close any um urethral sling. And so what are the benefits? Well, theoretically this avoids passing trocars through the space of ret CS or through the operator foramen. And these procedures should avoid bladder perforation, although I would, you know, caution everyone to continue to cystoscopy, do cystoscopy for these cases. It should avoid major vessel injury which may occur during retropubic procedures, and postoperative thigh and groin pain, which may occur after transoptertor um procedures where the tape passes through the entire transopterator complex. But what does the data show? And we always wanna make sure we're understanding sort of new technology, um, and what short term, medium term, and long-term outcomes look like. So we'll, we'll talk a little bit about the data now that we've um sort of become familiar with the procedure itself. So I love doing this when looking at something that's an update or sort of a novel technology, but when you go to PubMed, you can actually um sort your results by years and see how the data has um the qua quantity of the data has changed over time. And so you can see and 2014, a sort of 2024, as we get up to current day, we see a major uptick in data on um many things when you enter that in a search in PubMed. And that really begins in 2008 again coinciding with two or three years after the initial start of these mini slings coming to market, a little down trend at 2017 after we proved that the first models were not very effective. And then we see a major uptick in 2023 last year, and we're hearing a lot about the mini slings sort of in our field and when we're at conferences and among colleagues. So I think a lot of these studies are are very timely. And so this was an interesting study at 2022 non-inferiority randomized trial comparing the mini sling with mid-urethral slings, and this actually came out of the UK and they used two of the newer mini slings that were adjustable after you deploy them, and it took a look at about 300 mini slings and about 300 mid-urethral slings, and it looked at. at 15 and 36 months. And I just want to highlight the times of success. 15 and 36 months is early early to maybe mid-term follow-up, but these are not long-term follow-up. Um, this is not a long term follow up study. But success at 15 months was actually pretty good, and both groups were not inferior with 79% in the mini ling group and 75% The mid-urethral sling group meeting the success criteria and again non inferior. And then at 36 months, we see the success sort of persist with 70.2% in the midi sling group and 66% in the mid-urethral sling group meeting success criteria. So well done randomized control trial showing that at least at 3 years success between the two is relatively the same. They did also look at complications and so this is sort of where I think the data gets really interesting. Um, they took a look at, uh, you know, any adverse events that happened in these two groups and groin pain, interestingly, groin pain was the same between the two groups, even in the group that had the retro pubic mid-urethral slings. Um, the mesh exposure rate was higher in the mini. group 3.3% with mini slings and 1.9% with the mid-urethral sling, and the dysporinia was actually significantly high, 11.7% in the mini sling group and 4.8% in the mid-urethral sling group. So I think not only is efficacy important but also sort of adverse events and complications become really important any time we're thinking about new technology. In 2023, there was a Cochrane review. So now we're getting higher level data than are just well done randomized control trial. We're having, you know, a conglomeration of studies that we're taking a look at, and this Cochrane review looked at randomized control trials with at least one arm that included a single incision sling. It looked at 62 studies and the conclusions from this review became. That a single incision sling may be as effective as retropubic slings for subjective cure short term at 12 months. Um, and again, the studies going into this were very heterogeneous, so that's where that sort of caveat of May um comes about, but they are effective as trans obbitrators as trans arbitrator slings um for subjective current 12 months, and there are still uncertainties regarding adverse events and long-term outcomes. And so what about the time of prolapse repair? We are constantly when we are repairing prolapse, having a debate, do we sling, do we not sling? How do we test for cult SUI, you know, sort of what's the number needed to treat for sling. And so I think this is actually a super interesting study um. It was published very recently, May of 2024, very well done, multi-center non-inferiority randomized trial of about 250 patients who had stress incontinence and were undergoing vaginal prolapse repair, so they were either having coal placesis or reconstructive vaginal prolapse repair. Um, and they randomized patients to single incision, um, slings with a sham suprapubic incision or retropubic slings, and it found that single incision slings were non-inferior to retropubic slings for stress incontinence. And adverse events included treatment for your recession. But they did not differ. But if you do look at the numbers, at 16% of single incision slings had an adverse event versus 9% of the retro pubic group. Um, so very interesting and helps sort of contribute to our data about what to do with stress incontinence at the time of prolapse repair. And then one of the um advantages and sort of one of the things that when people talk about the benefits of mini slings or single incision slings that comes to to comes about is can we do this in the office? Can we do anything for our patients to offer them less um. Cumbersome experiences with shorter time to recovery and to go back to work, um, and sort of a a more seamless experience. And so there is a lot of data and a lot of, not a lot of data, there is a lot of talk around doing mini slings in the office. And so this is a 2023 retrospective coher study examining, implanting a single incision sling. Um, in two different sites, um, one is in the office and then like sort of like an office, um, OR, and the other is at a hospital-based OR, and it looked looked at cost in some efficacy data, although the efficacy data wasn't, um, very objective, um, but it basically looked at office based charges which is about $4000 for. Doing an office-based mini sling and then hospital-based charges, which was about $40,000 for doing an office-based mini sling, and the total patient encounter time was 50 minutes for the office and about 300 minutes for the OR, um, and they saw no difference between commonly associated or unanticipated adverse events and the patients were satis. in both groups. This isn't really the most robust data to make us say we should do all mini slings in the office, but this is something that people are studying more and more and it is an interest, um, you know, to bring patients procedural options that require less um sort of invasive workups and and less lengthy time to treatments. So in conclusion, I think, do I think the single incision sling is here to stay? Yes, I do think these sort of newer models have improved upon, um, the older ones, and I do think this might be something that lives in our space. Um, may I offer it to select patients? Yes, I think in a non-sexually active patient population, maybe those who are getting copal liesis, it's, it's something that I could offer. Um, and in patients who I want to Avoid the retro pubic space, and I have concerns about groin pain. Certainly it does. There is data to support its efficacy, um, and it does avoid those areas. Do I think it replaces yet full length sinks in my practice? No. And I think the major reason is because longer term outcome data is needed and hopefully as we get with more and more time from these uh products being on the market, we'll have more of that data come to light. Published September 21, 2024 Created by Related Presenters Christina Escobar, MD View full profile
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