Hello, good evening. Welcome to AUG's webinar series. My name is Tashi Chester, the Education and Meetings Manager here with AUG's and today's moderator for today's webinar. Today's webinar is titled Non-Mesh Surgery for the Treatment of Stress Urinary Incontinence in Women. Our speaker today is Dr. Peter Rosenblatt. Since 1995, Dr. Rosenblatt has been the Director of Urogynecology and Reconstructive Pelvic Surgery at Mount Auburn Hospital in Cambridge, Massachusetts. He served as the Director of Fellowship Program in the Female Medicine, excuse me, Female Pelvic Medicine and Reconstructive Surgery at Mount Auburn Hospital from 1999 to 2010. Dr. Rosenblatt is the Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School and is board certified in both obstetrics and gynecology as well as female pelvic medicine and reconstructive surgery. He has an active clinical practice and specializes in laparoscopic reconstructive pelvic surgery and minimally invasive treatments of pelvic organ prolapse as well as urinary and fecal incontinence. Dr. Rosenblatt has authored many original research papers in urogynecology and laparoscopic surgery and serves as the editorial board member and reviewer for several peer-reviewed journals in obstetrics and gynecology. He frequently lectures regionally, nationally and internationally on various topics including laparoscopic reconstructive pelvic surgery and innovation in gynecological surgery. He is the past president from 2019 to 2020 of the Society of Gynecologic Surgeons, SGS, and served on the Board of Directors for the American Urogynecologic Society, AUGS, from 2012 to 2014. He has been the video chair of SGS and AUGS and the American Association of Gynecologic Laparoscopics, AAGL. He has invented and licensed technology and served as major medical device companies and holds 17 patents in fields of urogynecology and general surgery. A couple of reminders today, this presentation will run for 45 minutes and the last 15 minutes of the webinar will be dedicated to Q&A. Before we begin, I would like to review some housekeeping items. AUGS designates this live activity for a maximum of one AMA PRA Category 1 credits. To claim your CE credit, you must log into the AUGS e-learning portal and complete the evaluation following the completion of this webinar. This webinar will be recorded and live streamed. A recording of the webinar will be made available in the AUGS e-learning portal. Please use the Q&A feature of the Zoom webinar to ask any questions of the speakers and a speaker will answer the question at the end of the presentation. Use the chat feature if you have any technical issues. I'm here as AUGS staff and I'll be monitoring during the chat to help you and assist. Dr. Rosenblatt, you may begin. All right, thank you very much, Tashi, for the introduction and for moderating. I'd also like to thank AUGS for putting this together, this event and actually all the entire series of educational and interactive webinars that they've had, which have been really valuable for our entire urogynecology community. So tonight, as Tashi said, we're going to be discussing alternative surgical treatments for stress urinary incontinence. These are my disclosures. Specifically, I am involved in consulting and research and legal defense work for several of the companies that manufacture and distribute midurethral slings for stress incontinence. So here are the objectives. You know, as we're going to see, midurethral slings today are the dominant surgical treatment for stress incontinence, but we'll discuss why urogyne surgeons should really expand their surgical repertoire beyond just slings. We'll talk about the indications and potential complications for these other treatment options, copula suspension, fascial slings and periurethral bulking, and we'll look at short and long-term success rate when it's available. So let's talk for a minute about why this is an important topic, you know, non-mesh alternatives for stress incontinence. There have been well over 3 million midurethral slings implanted worldwide since the 1990s, and we know from the Oggs position statement that over 99% of Oggs members use midurethral slings to treat stress incontinence. I mean, the midurethral sling has truly become a standard, if not the gold standard, treatment for stress incontinence in the U.S. since its introduction here in the States in 1998, and there have been, we all know there have been so many publications, over 2,000 publications in the medical literature, including the highest level of scientific evidence in peer-reviewed literature, including randomized controlled trials, systematic reviews, and meta-analyses. But we also know that in some countries, there have been restrictions put on the use of midurethral slings. Like in the U.K., slings are not considered the first-line treatment option for, surgical treatment option for stress incontinence, and transvaginal mesh for prolapse has either been banned or paused in many countries, including, as we know, obviously the U.S., but also the U.K., Australia, New Zealand, and France. And just so you know that this isn't kind of a novel new, you know, or something in the past, this is from, I saw this from just two months ago, this is from August, late August of this year, from New Zealand. The Director General of Health of New Zealand recommended a time-limited pause on the use of mesh to treat stress incontinence. So there's a pause in using slings in New Zealand. This is real. You know, the, this was, this was kind of what's started a lot of the controversy was October of 2008, when the FDA came out with this, what's called a public health notification. And this is what brought the concern over both transvaginal mesh as well as slings into the forefront. And when they talked about serious complications associated with transvaginal mesh for both POP, pelvic organ prolapse, as well as SUI. And the most common complication was erosion through the vaginal epithelium. Whether or not you want to call that serious, it was, you know, sometimes it required a second small operation, usually small operation, but they considered a serious complication. But what's interesting is this came out in 2008. We really didn't see a large number of lawsuits until several years later, when in 2011, the FDA came out with a subsequent notification, what was called a safety update, when they stated that these complications were in, you know, the two words were not rare, not rare. So let's look at what happened at the mesh litigation, which actually has been the largest mass tort in the history of the United States, more than silicone breast implants, more than hips, et cetera. So if you look at, there have been a total of over 108,000 legal cases filed. And you can see it really started kind of slowly in 2011, just 730 cases. But then after that came out, it jumped, it really jumped. So it was over almost 12,000 in 2012, and then 34,000 to 32,000. I'm getting a little feedback, Tashi, I'm not sure why. But let's look at actually the types of claims that were involved in these lawsuits. Interestingly, because we really think of these as a problem with POP, right, transvaginal mesh for prolapse, but actually the majority of them involve slings. And only 14% strictly involve POP mesh, but about a quarter of them involve both. So interestingly, by the way, as of just two months, last month, October of 2023, it's felt that about 95% of these lawsuits have been either settled or have been resolved somewhere else in the legal system. The other thing which is really interesting is that if you look at the cases where an implanting physician is named, in only 12% of these cases, is it a board certified FPMRS surgeon. So at 88%, it's not an FPMRS board certified physician. I think that's very interesting. And I'm sure many of us can relate to that, that the cases that we see are not our colleagues that we see at the meetings who are board certified. I think it's just very interesting. All right. So this is a fascinating graph, but I think it's also somewhat misleading. So what it seems to suggest, and it does suggest that the volume of slings and the sales of slings is decreasing significantly, right down 50% from 2015 to 2019 and a total down 62% from 2015 to 2021. So there's no question. And I don't doubt this, that the number of slings have decreased significantly, but in reality, there are much fewer surgeons performing slings. So not only have many, if not, I think most general gynecologists stopped performing slings, but also much fewer urologists are doing slings. So the mid urethral slings are being performed by a much smaller group of FPMRS surgeons. And they're just honestly, just so many slings, a urogynecologist can do with everything else that a urogynecologist is doing. So yes, there's been a trend downward, but I don't think that's an indication that slings are going away. It's just that the number of surgeons doing these procedures has declined significantly. So this was the joint position statement from Oggs and Sufu. The original one came out, this is from 2021. The original position statement came out in 2014, and it's been updated actually several times. This was the last one. There's no question that there are definitely patients actually, as well as physicians who conflate mid urethral slings with transvaginal mesh. And there are patients who may be reluctant to have mesh implanted. I mean, I think the key statement in this joint position statement is that the polypropylene mesh mid urethral slings are a standard of care for the surgical treatment of SUI and represent a great advance in the treatment of this condition for our patients. Listen, I've found in my own practice that once you explain the difference to patients between transvaginal mesh and mid urethral slings, and we actually give them a copy of this joint statement. It's rare that a woman would choose, in my experience, not to have a mid urethral sling for SUI if she desires surgery. Now, that being said, I literally had a patient this week who messaged me in Epic and decided against having synthetic mesh sling implanted in her, and we're going to be doing a laparoscopic BIRCWH on her. So here are the non-mesh surgical options I'm going to cover today for stress incontinence. BIRCWH, copal suspension, autologous fascial slings, and periurethral bulking. So why do we need to learn about these other treatment options? I think we've learned as a group, and for some people the hard way, that it's not good to be a one-trick pony. I mean, just look what happened to some of our colleagues, surgeons, who exclusively performed transvaginal mesh for POP. It was very difficult for them. So, you know, it's important that we present women with options, explain the difference between treatment options, and there are definitely clinical situations that call for different surgical procedures. I mean, there have been over 100 procedures described in the literature to treat stress incontinence, but it really comes down to just a couple that are, I think, very viable, and those are the ones that are mentioned here. Okay, so now let's talk about the open BIRCWH. So the BIRCWH came out in, John BIRCWH described this in 1961, and he published a series of over 50 cases in which support to the urethral vesicle junction was provided by a series of sutures attached to Cooper's ligament. And really, for nearly 50 years, the open BIRCWH remained the standard of care for many for the treatment of stress incontinence. And then, although it's certainly effective, it required a laparotomy, and patients often spent several days in the hospital. This is, you know, what I learned back in the early 90s. It did involve, you know, gaining access, as shown in that last slide, to the space of rhetzius. You can see the surgeon's finger pushing up in the lateral sulcus, very distal in the vagina. And this is a maneuver to remove or mobilize the fat off the endopelvic fascia with the surgeon's hand elevating the distal vagina at the mid urethra and the UVJ. And then sutures, usually permanent, but they don't have to be, are placed at these locations. And you can see in the corner there, in the upper corner, you know, full thickness, except the epithelium, and brought up through Cooper's ligaments on either side. So, in the early 1990s, it was described by Terry Van Kuy and Schuessler in 1991 to do this laparoscopically. I started doing it a couple years later. Many of my contemporaries started doing the laparoscopic birch in the early 1990s. So, it's really been 30 years. And I think maybe not every, but almost every birch now is performed either laparoscopically or robotically. And this is what it looks like. So, this was really the first minimally invasive approach to what was considered the gold standard at the time, but it's still required and requires today general anesthesia. But most patients wound up going home the same day. So, what are the indications for laparoscopic birch? Obviously, stress incontinence, urethral hypermobility, but probably best if you don't do this in any patient that has evidence of intrinsic sphincter deficiency. That would be like a patient with an empty supine, you know, a patient who has a positive empty supine stress test, you wouldn't do this. So, they have a, you know, they just went to the bathroom, they'd have a residual, they're in the lethotomy position, they cough, it's negative, but they do have stress incontinence, fine. And they should have normal parameters during urodynamics. Although we don't do urodynamics, mostly in patients who, you know, have not had previous surgery and don't have risk factors, you know, based on the value trial. So, let me show you a video of this, and I hope you can all see this. So, it does require gaining access to the retropubic space, the prepubic space. And most surgeons do what I do, which is they get intraperitoneal access first, although there are techniques that involve only preperitoneal access using a balloon dissector and never getting into the abdominal cavity. But I find it helpful, and I did it in this case, to backfill the bladder with somewhere between 200 and 300 cc's of saline. We stain it with methylene blue. And so, it's very easy to visualize the upper border of the bladder. And if you, you know, hopefully not, but if you got into a, if you got a, you know, had a cystotomy, you could easily repair it. And then you get into that really nice areolar tissue plane where, you know, you can see Cooper's ligaments there on either side. And the pararethral tissue can be cleared off of fat, which facilitates scarring. I'm using a laparoscopic kittener or a peanut with a finger in the vagina pushing up and just kind of clearing off that area. So, I think putting sutures there, but also this removing the fat helps the scarring. Now, by the way, I personally prefer traditional laparoscopy to robotic surgery in this case. And the reason is, and you can see this in this video, these are sutures being placed at the level of the mid urethra. This is Gore-Tex sutures, because I want a finger, you know, my non-dominant hand is in the vagina feeling to make sure that I'm not taking a full thickness. Well, I'm not going through epithelium. With robotics, you can't. So, it's all done visually. So, I'm using here Gore-Tex or, you know, PTFE sutures, but you can also use delayed absorbable or polypropylene, another, you know, non-absorbable. But I really think having a hand in the vagina provides that haptic feedback so that you don't perforate into the vagina. So, we place a figure of eight stitch through the endopelvic fascia at the level of the mid urethra, and then bring that up through Cooper's ligament. I'm not gonna tie that yet. I'm gonna put a second suture at the UVJ, again, full thickness, pretty much as lateral as possible into this tissue. And this is, again, a figure of eight stitch, pushing up. I don't mind a little bit of this bleeding. It actually helps with the scarring, so we try not to suction out the blood if it's reasonable. And then getting up through Cooper's ligament. And notice how the needle driver is coming parallel to the ligament so that the needle is perpendicular. At this point, you can see we did the other, her right side. Now we're, in this case, using an open knot pusher to throw down the sutures. Some people do use intracorporeal knots. I just find this technique really easy and fast. And that's pretty much it. You are left with suture bridges like this. You don't have to bring the endopelvic fascia all the way up to Cooper's ligament. You wouldn't wanna do that. And then we feel it's important to close the peritoneum to reduce the risk of bowel getting stuck in the retropubic space and possibly getting bowel adhesions in this area. And why do we care about that? Let's say the birch at some point failed. It's likely that patient may need a retropubic sling in the future. And if she had a bowel stuck in there, you could have a problem, a bowel perforation. So there are many different techniques to close the peritoneum. In this case, I'm using barb suture, running it through, and then you can go backwards a little bit as well. But you can do running suture with traditional knots, or you can see there braided suture with those absorbable suture clips. But it's very simple. It takes a couple of minutes, and that's the procedure. Procedure classically takes less than an hour. This, I wanna show you, this is fascinating to me, this graph, which comes from the Ward and Hilton study in 2005, and you can see culpo suspension is here in gray. And right around the year, which is actually the year that it came out in the US, but it came out in Europe before that. But look at how TVT, I mean, this to me is the classic example of a disruptive technology, right? So this was really evolutionary of slings, but revolutionary, right? This was disruptive. I mean, the number of culpo suspensions declined precipitously in a very short time span in the late 1990s, and then early 2000s in the US as well. But this is a classic type of graph that you see with a disruptive technology. So what about, how do we compare culpo suspension with TVT? And Ward and Hilton did this study, and this was an open culpo suspension. They did a multicenter RCT in the UK and Ireland in 344 women. You can see how many had each TVT or open birch. And the objective cure rate was actually, it wasn't statistically different, but it was 90% of the birch, 81% in TVT. So it wasn't statistically different at five years. Complications, there were a couple tape exposures, one erosion, I believe, that was into the urethra, but the birch had more pelvic organ prolapse complications as well. And this is from the Cochrane systematic reviews. And because the initial results that came out on laparoscopic birch were very varied and difficult to interpret, pretty much because there was so much heterogeneity in how people were doing the birch. Some use different types of suture material. Some people use mesh strips and staples. So it was a lot of, it was hard to interpret the data, but the Cochrane did this systematic review just a couple of years ago. And when they compared laparoscopic to open birch, laparoscopic had fewer perioperative complications, less pain you would expect, a shorter length of stay, but more costly. They also looked at laparoscopic birch versus TVT, and there was no difference in subjective cure at 18 years. So really both of them are very good procedures, one with mesh, one without the mesh. And this was just an interesting study a couple of years ago from a single surgeon who did 150 lap birches, and he had mean follow-up of 50 months. And so, good success rate, relatively low incidence of overactive bladder, no major surgical complications. So I think it's indicated for patients who, well, maybe mesh-averse, for instance. So let's look at, so who should you consider a laparoscopic birch rather than a mid-urethral sling? And I think I just said it, basically, either the patients who are really mesh-averse, even after you explain to them the difference between this and what's on TV. And also, and I threw in this picture, just if you're in there doing other laparoscopic procedures, in this case, like a paravaginal repair, I think it's totally appropriate to offer a patient a birch while you're in the area. Okay, so we're gonna move on to autologous rectus fascial slings. I mean, this is another option, and this comes from the Karam article in OBG Management. It's another option for patients who expressed reservations about synthetic mesh. This is also what people refer to as a pubovaginal sling, right? So it supports not the mid-urethra necessarily, but the proximal urethra and the bladder neck. I'm gonna show you a video which comes from the UT Southwestern group, Muir, Randhawa, Muir, and Korten. And so I thank them for allowing us to use this, but they're showing this in a cadaver. The rectus fascia is harvested, the fat's cleared off the rectus fascia, and then two incisions are made below this area, just above the pubic symphysis. And then sutures are placed, permanent sutures are placed through the edges. Now, the only difference here, instead of the mid-urethra, this is really the bladder neck and proximal urethra, where an incision is made at the level of the bladder neck, and dissection is performed, kind of standard dissection, but the endopelvic fascia is perforated behind the pubic bone with Mayo scissors, and Metzenbombs, and then the finger. And then shown here is an instrument like a Bozeman clamp or a ligature carrier is placed into the space of Rhetzius and guided out through the vaginal incision. Then the sling is brought up to the bladder neck and you got to suture it in place, you got to tack it in place so it keeps it at the UVJ. And then when that's done, then you tension it, and generally it's recommended to tension these across the midline over a couple of fingers so that you avoid excess tension. So this is not exactly the same as the, like the TVT tension free, it's a little bit looser, and a clamp is placed between the sling and the urethra. So this just summarizes it. So permanent sutures are tied across the midline over an assistant's finger, and the right ankle clamp is placed, or Metzenbombs, whatever is placed between the urethra to prevent too much tension. So the pubovaginal sling, you can use rectus fascia, you could use fascia lata from patient's own tissue from her leg. This was popularized back in the 1940s. So it's been around a long time, but it's important to remember that before mid urethral slings came out, slings were almost exclusively used to treat intrinsic sphincter deficiency, or as a salvage procedure for recurrent stress incontinence. We really were not doing slings to treat primary stress incontinence, but it can be used as a primary procedure, especially in mesh-averse patients. And so when would you do this? You might offer it in patients, besides that, patients who had radiated tissue, where you don't wanna use mesh, patients who have urethral injuries, or maybe a urethral diverticula, or a fistula, that would be also a good choice there. So there was a review of the literature done just a couple of years ago, where they reviewed 22 articles out of many articles related to this subject. And it really supports the autologous rectus fascial sling as a primary treatment for stress incontinence. Looking at the literature, the success rates huge range from 31% to 100%, mostly depending on the definition of success. But in a recent meta-analysis of 15,000 patients, the mid-urethral sling and the autologous rectus fascial sling had similar objective cure rates. And they were superior to BIRCWH in this study. So I'm sure you're familiar with the sister trial, which compared the BIRCWH and the rectus fascial sling. And the original sister trial looked at results at 24 months, so two years. But then they enrolled 482 out of all those patients for a long-term study, which was a five-year long-term observational study. And just, you know, the definition of continence was no urinary leakage on a three-day diary and no self-reported incontinence symptoms and no surgical retreatment for stress incontinence. So the rates were higher in the fascial sling, 31% than the BIRCWH. So it was statistically significant. And the satisfaction rate was higher, not that much, but it was statistically higher in the slings than the BIRCWH. But they had similar adverse events, pretty much. So that was Brubaker and the extended sister trial. So Schimpf and others from the SGS systematic review included RCTs from 1990 through 2013 with a minimum of 12 months of follow-up, comparing one sling procedure to another sling or to BIRCWH. And what they concluded was for midurethral sling compared to BIRCWH, the meta-analysis of objective cure showed no difference. So they recommended either, either a midurethral sling or a BIRCWH, they're similar. For pubovaginal sling versus BIRCWH, the evidence favored slings, pubovaginal slings for both objective and subjective cure. So they recommend comparing those to pubovaginal sling. And for pubovaginal sling versus midurethral slings, it favored the midurethral sling. So those are just important notes to make. All right, we're gonna move on to the third option, which is periurethral bulking. And this is an option that's received, as you all know, a lot of attention recently, but it's actually not new. I mean, the first commercially available bulking agent came out literally 30 years ago this year, 30 years ago. And that was Contagion. So let's talk about periurethral bulking. And this might be great for patients who prefer a less invasive procedure, potentially an office-based procedure with a lower side effect profile. The mechanism of action is just to improve mucosal coaptation and increase resistance of the urethra. So as I mentioned, it could be done as an outpatient office-based procedure. It can be done in the hospital under local anesthesia or a conscious sedation. It can be repeated as needed. And there's a very low incidence of complications. That's what's attractive to so many people about this. So the indications really are, according to the labeling, intrinsic sphincter deficiency. And poor surgical candidates, who would that be? Well, patients who have a high risk for anesthesia. They may have a stenotic introitus, so it's hard to do like a sling on them. Maybe advanced age patients, patients in their 90s, patients with severe obesity, patients who are anticoagulated, things like that. And in terms of results, the efficacy is different. It's modest compared to other procedures like slings, there's a low risk of adverse events. Repeat injections are common, and we have a little bit, but we have few long-term follow-up studies at this point. So here are the bulking agents that over the years have been available. And we always talk about this, that ideally the bulking agent should be non-reabsorbable, non-resorbable, non-immunogenic, non-allergenic, and biocompatible. The first one you can see in the middle here was Contagion, which was cross-linked bovine collagen. And that was used, again, that came out in 1993, but it was discontinued in 2011. And then you can see the others that have been recommended since then. So let's talk about collagen for a minute. So it was really limited when it first came out to patients without urethral hypermobility who had low leak point pressures. And it was introduced in 1993. And again, remember, this was the pre-TVT era by five years, which made it very attractive back then, because if you didn't do this, you did something pretty invasive, that was either general anesthesia, even the laparoscopic birch, or much more complicated, like an autologous fascial sling. You did have to do skin testing to see if you were allergic to it. And it was tolerated, but it would get absorbed over time. So you often needed to do re-injections. It should be remembered, though, that this is used as the control arm, collagen, as a comparator for almost every other bulking agent that has come out subsequently, including a bulk of it. So let's talk about the Cochrane database. They looked at this in 2017, and these were all randomized or quasi-randomized controlled trials. And there were 14 trials that included over 2,000 women. They were small trials, generally of moderate quality. And they said, basically, that the available evidence was insufficient to guide practice. They were looking at things like durosphere and macroplasty, coaptite. They all had comparable efficacy to contagion, which was the cross-linked collagen. But greater improvements, they noted, with mid-urethral slings, but obviously with higher risks. So what could be different these days? Well, let's look on the left side of this. This is what we've had, mostly, which are particulate combination gels. So it's little particles in a transient carrier gel. And the bulking effect is due to this chronic inflammatory response and the volume of the microparticles. But it depends on the tissue response. So we're talking about coaptite, macroplasty, chondrosphere. So there is this new homogenous gel where the bulking effect is due to the hydrogel, the amount of hydrogel you get. So what you see is what you get. And it's more predictable and controllable. That's the idea. So this is where bulk emit comes into play. And so it's called a polyacrylamide hydrogel. And it's mostly water. It's only 2%, 2.5% of this cross-linked polyacrylamide. The mechanism of action is it's not inflammatory. It creates bulk. And it comes with this proprietary delivery system, which is a very nice zero-degree urethroscope, short, and you can rotate the sheath. And I'll show you a video of the procedure being done. And you can see there are several cushions here that are being injected, just a couple centimeters distal to the UVJ. And you want to inject in several areas to bring the mucosal edges together in the midline, like this. And the endpoint is really when the mucosa comes together. You can even have the patient, you know, you're doing cystoscopy, the patient has fluid, you can have the patient cough and you can inject again. And the needle that this comes with shows you how your depth of penetration to the mucosa so that you can do it like this. So that is the system. It's very well tolerated by patients. Let's look at efficacy. This was a single blind study, again, comparing this hydrogel to collagen, just because all the other studies compare it to collagen. They don't really compare them to other commercially available today, bulking agents. And the other thing is this, is that unlike a sling, you know, you can, in this study, you could receive up to three injections at one month intervals. So they had, you know, 345 patients, many got hydrogel, 116 got collagen. And you can see that it was pretty much equivalent. The 50% reduction in continence at 12 months was pretty much 50% of the hydrogel and 55% of the collagen. And there was no stress in continence, you know, no stress in continence was almost half the patients in the study. And there were rare adverse events in each group. And about two-thirds of the patients got reinjected once, and about a third of patients got two injections after the primary injection. So this is, right now, as far as I know, the longest long-term study. And this was a three injection, three-point injection plan at 2, 6, and 10 o'clock. This was a single retrospective study in a hospital in Germany, median age 65. A third of the patients had prior surgery. Many of them had mid-urethral slings. And they were allowed to get a second top-off injection. And that occurred in about a third of patients at nine months. And the results at seven years, you know, it looks good. 67% of patients reported either being cured or improved. Now, when you break it down, it's 16% cured and 49% improved. So this is not the same results we're getting with slings. So I think we have to kind of reset our expectations. But very few, you know, issues, and very few patients had retention, and very few patients had UTIs. So potential complications, most common, just pain at the injection site, little bit of urinary retention, maybe a UTI. Rare things, you know, it's rare, you know, abscess, necrosis, erosion. So when do you consider periurethral injections? Well, I think we already talked about that. Primary, you know, procedure for patients who are mesh-averse or want to avoid surgery. I think a great indication, and it's a huge population that we really ignored, I think, for many, many years, besides doing conservative treatments like Kegel exercises and electrical stimulation, are patients that haven't completed childbearing. I think it's a, you know, there are 4 million births a year in the United States, and many women have incontinence between childbearing. And we generally say to them, fine, come back when you're finished having kids. Well, now we have something we can treat them with. And I also think it's a great way, if a patient either fails a midurethral sling or she has significant improvement but is not exactly where she wants to be, you can sort of top off the patient with a bulking agent. And like we said earlier, maybe a poor surgical candidate, elderly patient, et cetera, something like that. So this is actually my final slide. So just to summarize, non-mesh surgery for stress incontinence. You know, there are more than just these three that I talked about, but these are probably the most viable alternatives to midurethral slings for stress incontinence. And, you know, all of these may be used in women who are reluctant to have permanent mesh or in the clinical scenarios that we discussed. We do have long-term results available for the BIRCWH, laparoscopic BIRCWH, and the pubovaginal sling. I think we definitely do need more long-term results for periurethral injections. The one that we looked at, which was a seven-year study, is terrific. We also have to think about, you know, how do periurethral injections affect maybe future surgery, like doing midurethral slings. But I think bulking definitely has a role in certain populations, including women who desire future fertility. So here are references that I mentioned during the talk. I know it's impossible to write these down, but this is being recorded, so you can always come back and look at these if you'd like. And I think, I think we'll stop there. And Tashi, if there are any questions, I'd be happy. We have a few. I'm so excited. So our first question is, how do you determine the correct tension for the BIRCWH sutures? Yeah, that always comes up. I'm afraid you're not going to like my answer. It's kind of a gestalt thing. But I, you know, I think it's important, and again, this is another reason why it's useful to have doing laparoscopic. No, I mean, you can do it with robotics certainly as well, but having someone at the bedside pushing up on either side or feeling on either side of the urethra. And when they start to feel the vaginal wall pulling away from their hand, that's a good indication that you're creating just support for the urethra. Other people have said, you know, bring it even with the fascial white line, the arcus tendineus. And you're basically doing the same thing with a BIRCWH. I think a good way to think about it is you're doing the same thing with a BIRCWH as you do with a mid urethral sling. You're acting, you're creating a backboard underneath the urethra. So when the patient coughs, sneezes, laughs, the urethra co-ops against this backboard as opposed to someone who has urethral hypermobility. I think that's the best answer. Might not be satisfying, but that's all I'm going to say. Okay. So the next question, our speaker would like to thank you and then wanting to know, is there any new innovation in the pipelines using non-mesh incontinence surgeries other than the three options discussed tonight? Yeah. You know, I'm sure people have heard, we've been hearing for years about myocyte. So taking patient cells out of muscles, growing them and re-injecting them into the urethra. And I know one company is doing an active study right now looking at that. So it's, you know, there are people looked at stem cells, people looked at myocytes, you know, autologous cells. The issue there obviously is you have to, it's a several step process. And my understanding is at this point, it's expensive. It takes cells out of someone, grow them in a lab and then re-inject. As far as I know, that's the most innovative, you know, procedure that's being done today. I don't know of any others besides the usual, you know, single incision slings. Well, I guess non-slings. I think it's that the myocytes and the stem cells probably. Okay. I'll just say one more thing. People have looked at laser, like, you know, the various vaginal lasers that are out there. The studies that I've seen have not been really great data. So people haven't really accepted that yet, but some of the studies show some promise. So maybe improving the quality of the vaginal tissue itself may help. Thank you. Another question, without urodynamics, how do you determine SISD versus non-ISD USUI? Sorry. Yeah. A lot of letters there. Yeah. I mean, I think the one thing at least we do in our practice is if a patient has a positive empty supine stress test, they voided, they've got a normal PVR, they're in the lethotomy position. And when they bear down or cough, they leak. We question whether they may have stress intrinsic sphincter deficiency. There was one study years ago that suggested that if a patient hasn't had previous surgery, they have primary stress incontinence, they don't have mixed incontinence or it's, you know, their stress is much greater than urge. And you demonstrate the stress incontinence. Like we have a policy where we do not operate on patients just to tell us they have stress incontinence. They need to come in with, you know, either with a passive fill or we backfill them and demonstrate stress incontinence. But if they haven't had previous surgery, they haven't had radiation, then we assume they don't have intrinsic sphincter deficiency. And this was the Charlie Nager and the value study. The conclusions were that if you have a positive cough stress test, that's enough that you don't need to do in complex aerodynamics. But I would consider it in a patient had a positive empty supine stress test. Another question. Do you have any tips for decreasing pain for patients receiving peri-utile, I'm probably saying that wrong, sorry, injections in the office? Yeah. So we have, we have some people just do the injection itself. We've also done the injection where we go in and inject a local anesthetic into the urethra through the operative channel, wait a couple of minutes and then do the injection. That seems to be a nice way to do that. The only thing is the, the like lidocaine or marcaine, whatever you use does create a cushion itself. So what I have done in the past and it's just, this is just what I do. I'm not saying this is what you need to do, but is to do the injection slowly and then put your cystoscope all the way into the bladder. And the cystoscope sheath itself is sort of compressing the lidocaine and distributing it so that if you stay there for a couple of minutes and then come back out, it looks like it originally did. And you're not, you're not fooled that thinking that you've already done the bulking. So that's the only thing I can think of. I mean, you know, you could give patients ibuprofen beforehand. You could give them a little bit of a, you know, benzodiazepine, Ativan, something like that as well. That's all we've done. And, and I, and obviously we, we, we give them you know, viscous lidocaine into the urethra and wait, you know, five or 10 minutes before we start. Another question. How do you see the future of single incision, mid urethral slings compared to the traditional slings? Yeah, that's, that opens up, that's a whole nother webinar someone else is going to do, not me. So the studies that have been done on the single incision slings are very promising. I would like to see longer term studies, although we have studies going out now three years on some of the single incision slings that are out there. So I think it's, it's very viable. A lot of people have switched. You're probably, obviously compared to retropubic slings, you're going to get less bladder, you know, perforations, not that it's a huge deal, but you don't, you'd like to avoid it. Whether or not it translates to less thigh pain is actually somewhat questionable. There are some studies that suggest that even with single incision slings, you can get thigh pain. But I think there is a, there's definitely a movement toward single incision slings and this well-done studies to date are looking pretty promising. So. Okay, we have a few more questions. This one is actually advice. While we know the finding of ISD is not required for the use of bulkamid, but I have had insurance companies refuse the procedure if ISD not ID'd. Yeah. So actually my understanding is that it actually is required that the patient, you know, has some degree of ISD. Here's the deal. There is no accepted definition of intrinsic sphincter deficiency. It is not defined by MUCP. It is not defined by LPP. It's not defined by an empty supine stress test, and it's not defined by the appearance of the urethra on urethroscopy. All of those things I mentioned are suggestive of ISD, but no governing body has, as far as I know, has defined you must have these parameters in order to have intrinsic sphincter deficiency. So it's one response to that might be, look, a lot of women we know have urethral hypermobility and don't leak urine. So there must be some degree. This is what other people have said. There must be some degree of intrinsic sphincter deficiency in patients. The problem with their sphincter, if some people with urethral hypermobility leak and others don't, then there must be something wrong with that sphincter. So I think you could make an argument and put down intrinsic sphincter deficiency, but understanding that there is no standard accepted criteria for ISD. But I've heard the same issue, and that's just the way the FDA approval went. Yeah, I think that's about all I can say about that. Thank you. What would be your first choice for obese PTE? I think you're saying obese patients, I think is what that person said. Yeah, I guess I'm sorry. I didn't realize the abbreviation. So yeah, I think the issue there is when you're doing a retropubic sling on an obese patient, it's somewhat worrisome. As you place that needle up through the vaginal incision, and it's taken a while for that needle to come up to this suprapubic incision, it's somewhat concerning. I have found in my own practice that full-length trans-operator slings, most of these women, there isn't a huge distance like it is going from the vagina to the pubic area, to the mons, compared to going out to the medial thigh. I'm not convinced that... I'm not saying it isn't valuable, but I'm not convinced a single incision sling has the durability in a morbidly obese patient. So I favor a full-length trans-operator sling. You know, there's a lot of controversy there where a lot of people have this perception that trans-operator slings cause thigh pain. That has not been our experience in Cambridge after doing literally several thousand slings. We just don't see that. I think as long as you follow the instructions and stay below the adductor longus tendon and stay in the medial thigh, you can avoid long-term thigh pain. So that's been my approach to obese patients. What are your thoughts about the tiered approach to SUI treatment in Great Britain and Australia, first bulking and sling or failed urethra bulking? Yeah. Yeah. I don't think that the... It's just my opinion that the... And I think that's based on the NICE guidelines, I believe. I don't think the government should be telling or organizations should be telling us what to do. And thank God we don't have that in this country. So I think we have to just have that discussion with patients about what do we know about long-term success? The good thing about periurethral injections is that you're not painting yourself in a corner where you can't do other things. So it's not a bad idea. But if a patient wants one thing done, and one and done, as opposed to having to come back several times. But look, we have patients, just to think about it, look at Botox injections for overactive bladder. These patients keep coming back every six months, they seem to be fine with that. And so I think it's reasonable, a reasonable approach. And there are some women obviously who will not need to be re-injected. But I'd rather our organizations, professional organizations like OGS, making recommendations and not the government agencies. I think this is actually just, we have time for one more question. What is the best treatment option for ISD post-irradiation? Post-irradiation. Yeah, I think, well, I think you have two choices there and you should avoid mesh. And it's going to be either the rectus, what we talked about, rectus fascial sling or periurethral injections. I mean, classically, the periurethral injections were recommended for men in post-prostatectomy, kind of that scarred urethra. So you think about that. And that's when contagion was used way back in the 1990s. So I think either a rectus fascial sling or periurethral injections for irradiated pelvises. Thank you. So I think that is all the time we have for questions, but on behalf of OGS, I would like to thank Dr. Rosenblatt for today's excellent webinar. Please be sure to register for any of our upcoming webinars. And on December 20th, there will be a complex cases panel discussion with Dr. Cheryl Iglesias, Sean Menefee, and Catherine Matthews. You also have the option to submit a complex case for them to discuss. Please follow OGS on Twitter and Instagram. Check our website for any information on all upcoming webinars. And thank you for joining today. We hope you have a wonderful evening. Good night.

non-mesh surgery

stress urinary incontinence

SUI

Burch procedure

autologous rectus fascial slings

periurethral bulking

endopelvic fascia

urethro-vesicle junction

urogynec surgeons