All right, well, thank you for the opportunity to present our work. Here are our disclosures. Mid-urethral mesh slings are the gold standard surgery for stress incontinence. Globally, access to and availability of mid-urethral slings are threatened. Concerns regarding vaginal mesh complications have fueled this issue internationally. High-quality data regarding long-term outcomes are critical to inform this debate. Our group has previously reported that the 9-year risk of sling revision was 3.7% and that the 9-year risk of repeat stress incontinence surgery after initial sling was 13% in U.S. women. A recent study from England reported that the 9-year risk of sling revision was 3.3% and that that for repeat stress incontinence surgery was 4.5%. However, longer-term, population-based data beyond 9 years are limited. Thus, our objectives were to evaluate the long-term risk of sling revision for mesh complications or urinary retention and to estimate the long-term risk of repeat stress incontinence surgery after initial sling through 15 years. For our study, we used the Market Scan, Commercial Claims and Encounters, and Medicare Supplemental databases from 2001 to 2016. These databases contain inpatient and outpatient insurance claims from privately insured employees, retirees, spouses, and their dependents. These de-identified data have been shown to be valid and reliable. To give you a sense of the scope of this database, in 2016, Market Scan included over 30 million individuals. For our study population, we were interested in adult women who underwent a sling procedure based on CPT code. We wanted to identify initial slings, which we defined as no prior sling in the previous 90 days. So, our look-back period was 90 days. We chose 90 days to be consistent with the methodology of our prior study of 9-year outcomes. However, we recognized that a look-back period of 90 days may not be long enough. So, we also conducted a sensitivity analysis using a look-back period of one year to define our initial slings. So, to remind you again about our outcomes, among initial slings, we were interested in evaluating sling revisions, as well as repeat stress incontinence surgeries. For sling revisions, we also determined the indication, whether mesh complications, urinary retention, or other indications, such as pain, based on ICD-9 and ICD-10 diagnosis codes. For our analysis, Kaplan-Meier survival curves were used to estimate the cumulative risk of sling revision and repeat stress incontinence surgery. Recall that we also did our sensitivity analysis using a look-back period of one year to define initial slings. Here are our results. So, for our study population, our databases included over 306,000 women who underwent an initial sling during the 15-year study period. Here are the baseline characteristics in the table. For age, you can see the proportions by decades, and that 60% of slings occurred in women aged 40 to 59. For region of the U.S., the highest proportions were performed in the South, followed by the Midwest, West, and then the Northeast. For concurrent surgeries, 27% also underwent a hysterectomy. 60% underwent a concurrent prolapse procedure, with a breakdown of surgeries by compartment listed here. In addition, 26% of initial slings were performed as part of a procedure that occurred in an inpatient admission. So, to better characterize our study population, it's also important to understand the year in which the initial sling was performed in our databases. So, this figure depicts the proportion of slings performed in each year from 2001 through 2016. On the X-axis is the year of the initial sling. The Y-axis is percentage, and I also highlighted some important FDA information, including FDA clearance in 1998, as well as the two safety notifications regarding vaginal mesh in 2008 and 2011. You can see that our study population, excuse me, included slings from each year of our study from 2001 to 2016, with lower proportions in the early 2000s after FDA clearance, followed by an increase through 2011, and then decreasing proportions through 2016. All right, here are results for sling revision. This graph depicts the risk of sling revision by indication over time. The X-axis is years of follow-up. The Y-axis is cumulative risk. The black line is sling revision for any indication. The blue line, revision for mesh complications. Orange is revision for urinary tension, and in purple is revision for other indications. You can see that the risk of sling revision increases to 6% at 15 years, and that a higher proportion were due to mesh complications when compared to urinary retention or other indications. Here are results for repeat stress incontinence surgery. The table depicts the risk of repeat surgery after the initial sling by year of follow-up after, again, the initial sling. These same data are depicted in the graph on the right, and you can see that the risk of repeat stress incontinence surgery increases to 9.6% at 15 years. You may be wondering, well, what type of repeat incontinence surgeries were performed? And here's the data for that information. So on the X-axis is year of repeat surgery, and the Y-axis is percentage. And you can see that the most common type of repeat incontinence surgery was another sling, shown in the blue line, followed by urethra bulking in green, birth corpus suspension, and other surgeries were not commonly performed. For our sensitivity analysis, recall that we wanted to use a longer look-back period to define initial slings of one year compared to 90 days. And overall, the results were very similar. So if you just look at the 15-year risk for sling revision and repeat surgery, the estimates are essentially the same. There's just a little bit of a wider confidence interval for the one-year data compared to using the 90-day look-back period. The strengths of our study include that this was a population-based study with a large cohort of initial slings, again, over 306,000. We were also able to evaluate long-term follow-up through 15 years. Our limitations were that our database only included women with private insurance, so these results may not be generalizable to those who are underinsured or uninsured. In addition, we were unable to assess the specific type of sling performed based on our data source. In conclusion, the risk of sling revision for any indication was 6% at 15 years, and the risk of repeat stress incontinence surgery after an initial sling was 9.6% at 15 years. These results are not significantly higher than prior 9-year outcome data and lend support to the fact that slings are a safe and effective treatment option for stress incontinence over the long term. We hope that these data will help to inform the critical debates about mid-urethra slings. Thank you very much for your attention. Dr. Oliveira. Thanks, Jen. That was an excellent study. Cedric Oliveira from New York. I was just wondering, so based on these data, how do you interpret the most common reason for a sling revision, because although it was 6% for any indication, I was wondering, did they exclude the mesh complication group in the indication group? No, the any indication is everything combined, so of all indications, then we broke it down by indication, whether mesh complications, urinary retention, or other indications like pain. But overall, all comers, any revision with those sort of break down for indication. So how would you use that data to counsel a patient if they asked you, what would be the most common cause for my sling to break down over time, what would you tell them? Well, I don't know if it's break down, but sort of the most common cause of sort of requiring to go back to do a sling revision would probably be a mesh complication, so about half of the time, but that there are other reasons as well, but I'd say, you know, certainly there could be a variety of different reasons, but probably mesh is about half of the 6%. Thanks. Thank you. Dr. Madhavan. Jen, thank you, as always, great presentation. I'm asking this question from the epidemiologic perspective. I just wanted to make sure you're accounting, is the denominator accounting for people who may have had the sling when they didn't have the insurance, and then 5, 10 years later, now they have insurance, and they fall into the denominator, so did you account for the numerator and denominator in terms of all patients included are followed through 15 years? Yeah, so this is the thing. So, you know, Bhaji asked a great question about how are we defining the initial slings, right? Certainly someone who had initial sling and did not have this insurance would not have been captured by the database, and then let's say we pick them up, and we think, oh, it's an initial sling, and that really has to do with how long have they been insured, and within the database, and how long is your look-back period, so, you know, certainly I think a 90-day look-back period is not long enough because someone could have had a sling a year prior, and we would not have captured that, so that's why we did the sensitivity analysis using a longer look-back period of one year. We could go even further, and it would just decrease the N in terms of our database, but we have a fairly large cohort, so we can certainly do that and kind of look back further. I don't know if we could ever look back. We would not be able to know if they had a sling when they were under a different insurance plan or, let's say, Medicare or Medicaid, something like that, so that's definitely one of the caveats and the limitations of using this data source that's just insurance claims. Thank you. A really excellent analysis, but the interpretation, 6 years, I mean 6% in over 15 years, if the outcome is a repeat surgery, maybe it doesn't mean that it just did the complication delay because we very often see that the patient has symptoms right earlier, but they really postpone the repeat surgery, so I don't think that everything is just with the time. If the outcome is repeat surgery, maybe the symptoms were already earlier. Yes, thank you for that point. I mean, certainly patients could have symptoms earlier and not decide to undergo another sling or another procedure. Maybe they decided to use a non-surgical option, a pessary or Impreza or some other device, and we would not be able to capture that. This is just for insurance claims. Thank you. Thank you. Okay, thank you. Objection to the primary stress urinary incontinence, presented by Tommy Mickler. Thank you, and good to see so many people here at this time of the morning. I will be presenting our one-year results of the TBT versus bulkimy, a randomized clinical trial, and I'm sure for the audience, there's no need to tell about TBT, but bulkimy is a hydrogel that is currently being used from 2006, so more than 10 years in various countries around the world. However, in U.S., it's not currently available. As far as I know, the FDA process is such that it likely soon will, and already at this point, I want to suggest that those of you who want to learn more about it tomorrow, there's a lunch symposium on the topic. So here's my disclosures. I also want to emphasize that even though our study did get an unrestricted research grant from Contura, it's fully investigator-initiated, and the company has nothing to do with the data or how we present it. So bulking agents have been around for many, many years, and as I already mentioned, bulkimy, being a hydrogel, has been used safely for more than 10 years. However, the efficacy and also the comparison on current treatments, the data wasn't there, so that's why we went and did a study comparing bulkimy to a TBT. It's a single-center RCT. Here's the primary outcome, which was patient satisfaction. The main reason we chose patient satisfaction to give more broad overall approach to the outcome, but of course, we have additional outcomes on effectiveness, on complications. We used various questionnaires, also looking on pain, and currently we're also working on the cost-effectiveness studies. So we randomized more than 200 women. It's a non-inferiority on the patient satisfaction, as mentioned, and the inclusion criteria are exactly the same that we use in our clinical practice for TBT. So these were women that had already had conservative treatment on pelvic floor muscle training, and they were referred to us for TBT, and then we just requested if they would attend our study and be randomized to even either TBT or bulkimy treatment. We do all our procedures in outpatient setting, in local, also the TBT. We have a large size of an outpatient clinic where last year we did more than 700 procedures. We used TBT-X for the study, and the bulk commit also in similar manner done in outpatient setting, and we used a technique where we used four injection sites at 2, 4, 8, and 10 o'clock, and this product is such that you can actually see when you're injecting it, and the aim is to get cushions that meet a midline to get good coaptation for the treatment. And here is our study flow. At the end, we had a little bit more than 100 women on both arms. Here are the demographics. I want to emphasize that the data is presented on IQR on 25 to 75 percentile, so you see, for example, age, median, and then the IQR, meaning that we had, of course, a 25 percent higher age than you see here, and then 25 less than here. Same with the BMI, especially with the U.S. colleagues, I often get the question that where did we find women that were with BMI 25? Well, gladly, in the Nordics, we still have women with this size, and also I do get some comments on the urodynamics. In normal clinical practice, we do not do urodynamics on all of our patients. In the study, we did about 10 percent of the patient's urodynamics to confirm the clinical finding that it was a primary stress urinary incontinence. And here is our primary outcome. It was not a surprise to us that we got very high VAS on TBT 99 in average, but the surprise was to get 85 in average with bulk coming at one year. Also to give you some unpublished data, the current data that I show, that's just recently. You can find it online as an EPUB on Journal of Urology, but here's some unpublished data that we're currently writing as a manuscript on quality of life on the UDI-6 and IAQ-7. Both treatments reduced or improved in the domains that we looked in. However, TBT was also here better than bulk amide. Interestingly, in the RAN-36, only the physical functioning showed with TBT better than bulk amide. And also, the only worsening that we saw was in pain from baseline with TBT. However, between the groups, there was no differences, and in the PISC-12 questionnaires, there was no differences in the total score. Also, we looked on objective cure and, once again, very high results on TBT, which is similar as are in previous studies, but what was surprising that we got up to two-thirds of the women dry with bulk amide. The main difference, of course, then was on complications, even though the TBT complications are not high, they are there, as we all know, that are using TBT, whereas with bulk amide, we didn't see any complications, except de novo urgency was similar in both groups. And I think the pain issue is really what we're looking, especially in the long-term results. So to conclude, at 12 months follow-up, TBT showed higher subjective and objective cure rates than bulk amide in women with primary SUI, so meaning that in our trial, bulk amide did not reach the non-inferiority that we set. However, with both treatments, the satisfaction rates were high, and it appears that bulk amide appears or performs better in the primary SUI than as a salvage treatment that we've used it previously. And the complications were almost exclusively associated with TBT, and of course we're following our patients now, a year from now we'll have the long-term three-year date available. And this is my last slide as a take-home message. I think bulk amide is a good option for primary SUI because of the fact that the satisfaction rate was very high, subjectively 92% were cured or improved, and objectively two-thirds. However, we have, of course, women that expect to be fully cured with the primary treatment, and therefore I think for those women, obviously TBT is better in the first line. Thank you for your attention. I'd like to thank Aux and Iyuga for the opportunity to present our data on the randomised controlled trial, comparing efficacy and safety on the TBT in the monarchs, the peripheral slings, in women with urodynamic stress incontinence, and intrinsic sphincter deficiency. Here are our financial disclosures. So the primary hypothesis of the trial was that at the time of the beginning in 2004, there was no RCT comparing a retropubic sling with a trans-obturator sling in the subgroup of women with urodynamic stress incontinence and intrinsic sphincter deficiency. Hence, we thought that it was worth investigating, and we picked the primary endpoint as failure of the primary sling procedure and the need for repeat surgery, and also investigated secondary endpoints with quality of life outcome. It's a prospective randomised controlled trial, and inclusion criteria were the finding of urodynamic stress incontinence with an MUCP less than 20 and or an abdominal leak point pressure of less than 60 centimetre water level. The patients obviously had to be able to give consent and were willing to participate, and we excluded women who were medically unfit for surgery or had any signs of pelvic infection. Pre-operatively, we did a comprehensive assessment on each participant with a complete history, physical examination, we did the urodynamics, the participants completed a three-day bladder diary, we did questionnaires, and the consent. Post-operatively, at the six-month visit, we repeated the history and the examination and all quality of life measures, but we also repeated the urodynamics to get some more objective information how these women were travelling. And from then on, we tried to follow them yearly. This is the flowchart of the trial. I'm sorry it's a little bit busy and small, but in the end, at the 12-plus year mark, we managed to complete 52 patients in the retropubic arm and 57 out of the 82 original in the trans-opterator arm. This is the Democratic data of both patient groups at the time of enrolment, and at the time, it was quite even, and there was no significant differences in the two groups. And I'd like to point out that our age groups were quite high in 2004, hence that explains that a substantial number of our patients, unfortunately, had passed away by the end point, now at 12 years plus. The results of the study were very interesting. This was presented at the six-month mark and at the three-year mark at iUGA already, and there was a significant difference between the both treatments already at the six-month findings, and this continues on to now the 12-year-plus findings where it has basically ended up to be one repeat sling in the retropubic arm and 20 repeat slings in the trans-opterator group. The Kaplan-Mayer survival curve shows that the risk of failure in the trans-opterator group was 19 times greater than in the retropubic arm, and that if we'd had used retropubic slings exclusively in this subgroup of women with intrinsic sphincter deficiency, we would have avoided one in five repeat surgeries. Coming to the complications, this slide shows you the complications from the four-year to 14-and-a-half-year follow-up. So the early complications were already presented in the past, and it's interesting to see that there is still, as we know, mesh exposure and excision of mesh due to exposure is necessary as a late outcome. There was one patient who required a urethralysis, which was done by a urologist, and I had only limited information about her. And we did find that there was pain identified in the groin in both groups, but only one patient required a partial removal of the tape in the trans-opterator group to resolve the pain. And one patient received a cystectomy with complete removal of the sling. Stress urinary incontinence not requiring surgery was found in both groups, but there was no significant difference. The TOT fares a little bit worse, but these women basically were treated with conservative measures and didn't require any further surgery at the 12-plus-year follow-up. Overactive bladder symptoms were present in both arms, with both participation groups showing about a 60% to 70% rate of overactive bladder that did not require any specific treatment. And that may well be due to that our patient cohort has now aged significantly, and we are not entirely sure if this is related to the sling. And one patient in the retropubic arm received Botox and sacral nerve stimulation as treatment. The quality of life questionnaires in both arms were overall showing an improvement for pre- and post-operative assessment in all three endpoints, and there was no significant difference between the groups in the UDI-6 in the total score, as well as in the analysis score 2, 3, and 5. Now, we thought it would be interesting to see if the patients would be game to actually recommend their surgery to a friend or a relative, especially as in Australia there's been quite heated discussion about the slings lately. And the majority of patients actually in the participation group without repeat surgery would say definitely yes or probably yes. I thought it was quite surprising to find that even patients who had a repeat sling, so out of 14 patients that we could follow with a repeat sling at the end point of 12 plus years, would say yes, I definitely or probably recommend this procedure to my friend or relative. So in conclusion, women with pseudodynamic stress incontinence and intrinsic sphincter deficiency are significantly less likely to require further surgery with a retropubic sling procedure as their primary surgery compared to the trans-opterator route. This was reported at six months, three years, and 12 years, and it's holding strong. There is probably a comment to make on urodynamics assessment prior to initial surgery, as if identifying this subgroup makes a difference in what treatment they receive, it appears to be worthwhile. But if multichannel urodynamics is not available or you choose not to do it, you may choose to use the retropubic sling as a treatment of choice, as you will capture that subgroup as well in your treatment. Long-term results of our studies suggest that women with USI and ISD should receive a retropubic mid-urethral sling rather than a trans-opterator sling. And we will continue with our follow-up. Thank you very much. Your group are to be commended on the long-term follow-up and the completeness of your data. It's very difficult for many of us to retain patients like that. We do have time for a couple of questions, because the last speaker has withdrawn. Thank you very much. Tony Vazzi from Lebanon. Now, sure enough, the most important variable is the route, trans-opterator versus retropubic. But was the retropubic brand a TVT gynecare? It was the TVT, the original TVT. Okay. Because the brands are not comparable. So you're comparing a TVT gynecare to AMS trans-opterator. And these measures may not behave the same. Actually, it was proven that they don't behave the same, at least not. So while the most important factor, of course, is the route, there's another factor not accounted for, which is the type of the mesh. Would you agree? Sorry, the type? The type of mesh. Yes. There's a possibility that there's a difference due to the different products. But, well, I mean, that is something that we chose at the time in 2004, because they were the most used slings at the time in Australia. I thought gynecare introduced the trans-opterator route first, no? No, no, no, no. The Monarch came before the TVTO. Charlie Nager, San Diego. In looking at your data, I didn't see any significant differences except for repeat surgery. And my understanding of the study is that surgeons were not blinded to what procedure they had, and the salvage operation was always a retropubic midurethral sling. So couldn't your results be explained by surgeons are more likely to do a retropubic sling in someone who has had a previous opterator sling than someone who had a previous retropubic sling? The question is, most surgeons are less willing to do the same surgery twice, and they're more willing to do a salvage operation, a retropubic sling, if they had a TOT. And since that was the only difference, couldn't it be possible that since your surgeons weren't blinded, they were more willing to reoperate on someone who had an opterator sling than a retropubic sling? Basically, the decision to have a repeat surgery would have been lying with the patient, depending on the severity of their symptoms. And we basically assessed the patients prior to repeat sling anyhow, on an objective measure, and the choice of the sling was basically due to the protocol. But obviously, we knew that they had a trans-opterator tape, but the patients basically presented with significant stress incontinence and said, well, I need something else done about it. And then we followed the protocol of the trial, saying, OK, we will insert now the retropubic sling, because that was our fallback sling for the repeat surgery. Does that answer the question? No, but it does replicate data that have been published from other centres, showing that the efficacy of a retropubic tape is greater than a non-operator tape. It's just these days are a much longer term. Nick Morse from Boston. I'm interested in your opinion about something. So you had more than a 20% difference in the primary outcome but the subjective symptom scores, you couldn't detect a difference between the two groups. So to me that, and I've seen that in many sort of, you know, studies of different kinds of pelvic floor disorders, so are our symptom-specific, you know, scoring systems, are they sensitive at all? I mean it's... Well we were puzzled by that too, that actually the patients, even when they came and they said, I'm still wet, and they filled in the questionnaire, they were still happy. And you're thinking, I don't know if that's due to that we're actually trying to help them and that we're trying to do something, or if the actual tool is not, as you say, sensitive enough to pick up the differences. But also our groups is 82 versus 82, so if you would repeat that in a study with a much larger number, you're probably more likely to pick up a difference, I would have thought. Hi, I'm actually Jackie Zalou, one of the residents at University of Virginia, and thank you for the opportunity to present our work today. We have no disclosures. Historically, urodynamic testing has been used as part of the preoperative workup for stress urinary incontinence to guide surgical decision-making and to optimize patient counseling. The notable 2012 value study, a UITN multi-center randomized control trial of women with indexed stress urinary incontinence undergoing mid-urethral sling placement, randomized patients to either urodynamics or office exam alone, and found that the use of preoperative urodynamics had no benefit with regards to surgical success, patient satisfaction, or safety. Subsequently, various organizations have called for the omission of routine preoperative urodynamics for uncomplicated stress urinary incontinence patients, and notably among these are AUGS and SUFU in conjunction with the AUA. Two prior studies have looked at the use of preoperative urodynamics in such patients following the value trial. Of note, these are in very specific populations. The first, by Lippman and others in 2015, looked at a Kaiser Permanente population in Southern California, and the second, the Lloyd and others study from 2017, looked at a large academic center, the Cleveland Clinic, and both reported significant practice changes following the value trial publication. However, a broader, more general population-based assessment has yet to be done. It is with this in mind that we aim to assess the use of preoperative urodynamics in women undergoing urethral sling placement following the May 2012 publication of the value study. To do so, we obtained data from the Virginia All-Payer Claims Database from 2011 to 2016. This database was established in 2011 and includes medical claims information for Virginia state residents insured through Medicare, Medicaid, as well as private commercial insurers. We used ICD-9 and CPT codes to select for women with a diagnosis of stress urinary incontinence undergoing a sling procedure. We considered urodynamics to be done preoperatively if there were also claims for CPT codes for urodynamics within six months of the sling procedure. In keeping with the value study population, we excluded patients that were non-indexed by screening for CPT codes for OAB, urgency urinary incontinence, neurogenic bladder, or prior anti-incontinence or pelvic organ prolapse procedures. We then performed longitudinal analyses to assess the impact of the value studies publication on the use of preoperative urodynamics. Accordingly, we identified over 44,000 women with a diagnosis of stress urinary incontinence, and nearly 7,000 of these patients were treated with a urethral sling. After excluding our non-indexed patients, we found that nearly 63% of women underwent preoperative urodynamic testing over the study period. This graph shows the number of slings performed per year over the study course. In orange, you'll see that the use of preoperative urodynamics in these slings decreased over time. However, what you also see is that this is in the context of an overall decrease in slings performed over the study period. We have attributed this to the 2008 FDA warning regarding the use of transvaginal mesh in pelvic organ prolapse and anti-incontinence procedures, and this trend has been well described in the literature previously. We were more so interested in the proportion of slings that had preoperative urodynamic testing, however, and thus performed a beta regression with a logit link, which is shown in this graph. You'll see that we had a decrease in 10 percentage points over the course, from 68% to 58%, and our model showed that this decline was statistically significant and sustained, with about a 1% decrease per month over the study period. This regression analysis doesn't account for the specific time point of the value trial publication, and thus we performed an interventional time series model, called an AREMA model, to look for whether or not the specific publication date was significant in these trends. You'll see that this is on the y-axis is the number of slings, the x-axis is the date, and it shows the number of slings performed with preoperative urodynamic testing. This model did not reach statistical significance, but when we performed a sensitivity analysis, where we included our non-index patients, this did reach significance. So in summary, this is the first study of the use of preoperative urodynamics prior to sling placement following the value trial in a broad, generalized population, and we found that the majority of patients still have urodynamics performed prior to their sling procedures. We found a modest decline in use following the value study. This is notably a smaller decline compared to prior studies, but this is in a generalized, heterogeneous population that is probably more reflective of real life mix of practice settings and various payers, and we believe that our statistical analysis with longitudinal analyses inherently is less susceptible to unmeasured confounders compared to just doing a pre- and post-comparison testing. Our findings highlight the fact that further study is needed to investigate the trends and the use of preoperative urodynamics, as we all strive for evidence-based and cost-effective care. Thank you. The paper is open for questions, but I think it's quite reassuring that the majority of women are still undergoing urodynamics prior to surgery. I don't think there's anything wrong with it. It's a test. It's not expected to improve the outcome of surgery. It's expected to inform, so I think that's very good. Yes, but it's quite costly to the system. Just a suggestion for future research, if you're going to do this, if you do questionnaires or something to people, you might be interested in finding practice patterns and asking them whether they're on salary, salary productivity, or, you know, eat what you kill, because I think you'll see practice patterns different on how people are paid for what they do. Hi, Elliot Greenberg from Springfield, Massachusetts. This is very useful data. Thank you for presenting it. My question is, were you able to differentiate, or is there a way to differentiate, how many of the urodynamic patients after the study had mixed incontinence versus pure stress incontinence, because that might influence urodynamics. That's a really good question. One of the limitations of the Abusing Medical Claims database is that we're really limited in understanding all of the, completely the comorbidities of the patients. We didn't, we didn't do an analysis that looked at whether or not there was a new diagnosis later of mixed urinary incontinence, but that'd be really good, good to look at. I would think that you could certainly gather coding for pure stress urinary incontinence versus some mixed urinary incontinence, whether they listed as urge and stress or something along those lines. Yeah, it's just that the problem is that we can't define stress predominant versus urge predominant mixed incontinence, and that's why we were a little bit more limited. I have no disclosures. Mixed incontinence can be a challenging condition to manage. First-line management often includes behavioral and pelvic floor muscle training and overactive bladder medications. Guidelines in general have cautioned that surgery may worsen the urgency component. The ESTEEM trial and other secondary analyses of previous studies have showed that up to 85% of women reported that they were much or very much improved after mid urethral sling in mixed urinary incontinence. We still have limited data on risk factors for surgical failure in women with mixed incontinence, and identifying prognostic variables can help to inform treatment expectations. Our objective was to identify risk factors associated with treatment failure one year after mid urethral sling surgery in women with mixed urinary incontinence. We performed a planned secondary analysis of the ESTEEM trial, which was a randomized trial comparing the effect of mid urethral sling with and without perioperative behavioral and pelvic floor muscle therapy in women with mixed urinary incontinence. We included women who are 21 years of age or older, reporting moderately to severely bothersome stress and urgency incontinence, and documenting at least one stress and one urgency incontinence episode on a three-day bladder diary. We excluded women with anterior or apical prolapse at or beyond the hymen, or women undergoing planned concomitant surgery for these conditions. We also excluded women with prior sling, and women who were currently on overactive bladder medication and unwilling to discontinue. The ESTEEM trial interventions included mid urethral sling only group, which included retropubic or trans-operator approach, versus combined treatment, which was mid urethral sling plus six months of perioperative behavioral and pelvic floor muscle therapy. Our measures relevant to the secondary analysis included baseline urodynamic testing within 12 months prior to enrollment, and patient reported measures including the urogenital distress inventory, the incontinence impact questionnaire, the overactive bladder questionnaire, the patient global impression of severity, and a three-day bladder diary. Assessments occurred at baseline 3, 6, and 12 months. Treatment failure was defined as meeting criteria for any subjective and or objective failure components, which are broken down here. Subjective failure was defined as not meeting the minimal clinically important difference, or the MCID, for the UDI total score, which was 26.1 points. Objective failure was defined as not achieving at least 70% reduction in mean incontinence episodes per day on bladder diary, or having undergone additional stress and or overactive bladder treatment within 12 months. Five varied tests of association with failure were performed, and we used logistic regression to predict treatment failure, adjusting for a site and treatment group which were forced variables, and we assessed clinical and demographic variables with P less than 0.2. Those were explored in the model. We used a backward selection model, and we assessed potential interaction effects with the treatment type, and ROC was used to assess model fit. 402 women had complete data and were included in the secondary analysis. Of these, 29.6% met the definition for treatment failure, 3.5% were subjective failures, 28.5% were objective failures, and 2.6% were both subjective and objective failures. This table shows our baseline characteristics of the population failure versus success, and we've bolded the variables that had a P less than 0.2 that were explored in the model, but I'm going to I'm just going to sort of highlight the ones that were statistically significantly different on the bivariate analysis. So women who were failures had a higher BMI and a higher proportion had tried overactive bladder medication, 51% versus 34%. Women who failed had a higher number of mean urgency incontinence episodes per day on the diary, 3.1 versus 2.4. They also had higher IIQ scores, worse OABQ quality of life scores, and a higher UDI irritative subscale score. Urodynamic parameters that were different between the groups, volume at first urge, failure group was a little bit higher. A higher proportion of women who failed had detrusor overactivity, 42% versus 25%. Valsalva lead point less than 60, 41% versus 27%. This table shows our multiple logistic regression results for treatment failure. So the independent predictors were detrusor overactivity with an adjusted odds ratio of 2.72, lead point pressure less than 60, adjusted odds ratio of 3.13. Prior overactive bladder medication, adjusted odds ratio of 1.89, and higher BMI, adjusted odds ratio of 1.05. In addition, there was a significant interaction effect between the baseline UDI irritative subscale score and treatment that the patient was randomized to. So for illustrative purposes, we've broken up the UDI irritative subscale score into tertiles, so 25th percentile, 50th percentile, and 75th percentile. And you see at the higher UDI subscale scores, there was an increased odds of failure. So just to sort of walk this through, women at the 50th percentile of the UDI irritative subscale score who were randomized to sling only had a 1.93 higher odds of failure compared to those who were randomized to combined treatment. At the 75th percentile, here, women who were randomized to sling only had a 4.51 odds of increased failure compared to those randomized to the combined group. In addition, higher baseline UDI irritative, that score itself was a predictor, so the UDI irritative subscale score MCID is 10.2 points. So when we looked at increments of the MCID for the UDI irritative score, you see that women in the sling only group, for each increase in 10.2 points of the score, women randomized to sling only were 1.45, had a 1.45 increased odds of failure, but that effect isn't seen in the combined group. So this figure just kind of illustrates this interaction effect a little bit in more detail. So we've got treatment, I'm just going to orient you guys, so sling only here is on this side and the combined group is over here. This is probability of failure. The blue bar is the 25th percentile of the UDI subscale irritative score. The red, 50th percentile, and green, 75th percentile. So women in the sling only group had, women in the sling only group with higher UDI irritative scores had higher probability of failure, you see that here, but you see the combined group women had a low probability of failure regardless of their score, so that wasn't affecting that. So basically the higher the UDI irritative score, the more likely you are to benefit from combined treatment. Strengths of our study, this is a planned secondary analysis from a large multi-center randomized trial with a well characterized patient population. We used validated subjective and objective measures and had a wide range of mixed incontinence patients. Weaknesses included that we excluded women who had a prior sling or had anterior apical prolapse or were undergoing concomitant surgery for that. In conclusion, risk factors that can help predict sling failure at one year in women with mixed incontinence include certain baseline urodynamic parameters including the presence of detrusor overactivity and leak point less than 60, being on prior OAB medication and higher BMI, and in the sling only group, baseline UDI irritative subscale score, so higher scores predictive of failure. Women reporting higher baseline UDI irritative subscale scores may benefit from combined treatment. We hope that this information can aid in counseling of women with mixed incontinence. Thank you. I had a quick question for you. So I feel like what we're measuring though for failure is a lot of urge, if I'm correct. So why was, so urge as, retreatment for urge or OAB was considered part of objective failure, correct? Yep. And so why would we assume that the sling would help with the objective failure? Why was the OAB treatment included as a failure? So the primary aim of the ESTEEM trial was to look at, you know, whether combined treatment was better than sling only in women with mixed incontinence, and actually we found a very low failure rate in general in the population. So in the sling only group, retreatment for overactive bladder or stress incontinence was about 10%, and the combined group was 5%. So sling, I mean, sling seems to be effective for just for treating the overactive bladder component and mixed incontinence as well. Hi Vivian, Catherine Matthews from Wake Forest. Can you help me understand when it seems to make a difference to initiate the combined therapy? Is it helpful in these mixed incontinence patients to do the pelvic floor physical therapy preoperatively or postoperatively or both? So I think that's a really good question. So in our study it was one pre-op visit and five post-op visits within the six-month period, and then the final outcome was that one year. So for, you know, based on the secondary analysis, it looks like if you have women, I mean UDI, the UDI irritative subscale score, which is reflective of, you know, irritative symptoms, that seems to be the predictor that suggests that those women would be do better with combined therapy. We'll do two questions. You are too kind. Not good to discriminate. Sorry, I couldn't see you. Both last questions. Go ahead. I was just wondering, did you consider excluding those who had to stop an OIB medication in order to be participants in the trial to see if that affected the outcome? I'm sorry, did we consider excluding women? Did you consider doing another analysis excluding those patients who were on an OIB medication who stopped, and then looking at how that affected the risk factors for treatment failure? No, but that's certainly something we can do. Dr. Iglesias. Shirelle Iglesias, our nation's capital. Love this work. Kudos to the network. You have a calculator based on the risk of predicting the stress incontinence after prolapse surgery. What kind of calculator can we use? This is all very important, but for me to check the UDI 75th percentile, it's not going to happen for me. Yet I want to be able to talk to my patients about the findings of the study to say, sling first, your urge is going to get better. Behavioral first, and I don't know what's going to happen to your urge. I mean, what do we have? It's all, it's very important to count sling, particularly timing of sling. Yeah, I love it. We're on the same wavelength, and I think that would be a good next step to really be useful clinically. Thank you. Good morning. I'll be presenting the 12-month outcomes of a trial comparing two different techniques to tension retropubic slings. For my disclosures, this trial was funded by Boston Scientific. It was an investigator-initiated trial, and the company was not involved with the protocol data or analysis. Options to determine the optimal tension of a retropubic sling include provocative testing, such as coughing during the OR or suprapubic pressure, or using standardized methods, such as spacers underneath the sling. Standardized methods are very common, as general anesthetic or deep sedation may leave a patient unable to cough, and crude maneuvers may not mimic real-life forces. The existing data on the best practices to tension a sling interoperatively are minimal. As such, we developed a trial of two techniques. We chose the use of Mayo scissors in the suburethral space, compared to a fixed loop of tape 14 millimeters long, using a Babcock clamp. It was a randomized clinical trial to determine superiority. It took place at four centers in Western Canada. Surgeons were urogynecologists and urologists that had all undergone additional fellowship training, and it was a one-to-one allocation. The outcomes were assessed by a blinded assessor who was at the urogynecologist that did not perform the sling. We had a primary outcome of abnormal bladder function. This was a composite of bothersome SUI or OAV reported by the patient, a positive cough stress test at the 12-month visit, retreatment for SUI in that window, or post-operative urinary retention, which was catheterization at six weeks or beyond, or intervention for obstruction in the 12-month window. We chose this composite as it gave weight to the myriad of poor outcomes that can occur after a mid-urethral sling. Similar outcomes have been used in the past. For secondary outcomes, we collected data on catheterization, standardized questionnaires, pad test losses, uroflow parameters, prescriptions to treat OAV after the sling, and a vaginal exam. Our sample size was 318 women. We registered our trial and published the protocol a priori. We met our recruitment targets and our retention targets. There were equal allocations between each group and no crossover. There were no baseline differences between our patients. Our patient population was predominantly Caucasian women who were Paris, non-smokers, approximately 50 years old, with a BMI of 29. They had similar questionnaire scores at baseline between each other, similar profiles of incontinence, and similar uroflow parameters. Looking at the operative details of the two techniques, there was no difference in the mean time to perform, as this was a concern that the Babcock technique is a little bit more finicky and could take more time in the OR. They had similar anesthetic profiles in each group, so we feel like the anesthetic cannot account for what we did find, which was differences in catheterization at discharge. For both isolated TBTs and those that occurred with prolapse surgery, there was a statistically higher rate of catheterization at discharge for the scissor tensioning group, as well as a longer median length of catheterization. For our primary outcome, we did find a difference in the composite, with 30% of the scissor tensioning technique meeting the criteria and 18% of the Babcock group. Looking specifically at the components, this was driven by the fact that there was a statistically higher positive cough stress test in the scissor group and higher rates of urinary retention in the catheterization and the surgical intervention to release the sling. No differences existed in the questionnaire scores at 12 months or in pad test losses. However, in other secondary domains, such as mess exposure, there was a statistically higher mesh exposure in the Babcock tensioning group. There were more prescriptions for oral overactive bladder medications in the TBT group who were tensioned by scissor, but there was no difference in the number of women who moved on to bladder Botox after TBT. Uroflow parameters showed a slightly lower peak flow rate and slightly higher post-void residual and a higher proportion of women having a flattening of their uroflow curve, suggesting subtle obstruction. So overall, we did find a difference in our primary composite and it was the result of higher rates of urinary retention and a positive cough test in the scissor group. This suggests that the scissor technique may be tighter and it's supported by the uroflow parameters at 12 months. However, despite being tighter, the scissor technique does not result in higher rates of stress incontinence cure. We did a sensitivity analysis excluding all of the women who had their sling laced to make sure that this was not artificially bringing down the scissor group and again it confirmed that there was a higher cough stress test being positive, but when you put that in context with the pad test and the patient reported outcomes, we feel that the two are equivalent in terms of cure. The looser Babcock approach is associated with lower rates of urinary retention, however it appears to carry an increased risk of mesh erosion. So while we find that the two groups have similar rates of SUI cure at 12 months, what really the finding is is that the post-operative course differs between the two. The scissor technique requires higher levels of intervention for obstruction and Babcock may require more late intervention for erosion. The results of this trial allow surgeons to make an informed choice regarding surgical techniques for retropubic sling tensioning and we feel the information can be applied in different ways. Some may choose to use this as a broad practice pattern using only one technique. Others may choose to tailor it to a patient, so if they have erosion risk factors you may choose to use a scissor. If it's somebody who's anxious about catheterization or physically unable to, you may choose a Babcock technique. It also has utility in teaching trainees and low-volume practitioners as well. I find that the dissection and passing the needles is not the hard part of teaching these procedures, it's really the gestalt of tensioning that sling that's hard to pass on. Thank you. While people are coming up to the microphone, I have a quick question. What was the measurement that you used for the Babcock? Sorry, I zipped past that. It's 14 millimeters. And was that chosen arbitrarily? No, that is chosen by a description from Jeff Cundiff, so reference number five is where Dr. Cundiff describes this technique. Camille? Actually, thank you for the result. Could you explain, because you said in scissor groups there's a high retention rate, at the same time there's a high rate of incontinence rate, more incontinent ladies in the scissor group as well. How does that go together? Yep, so that was a surprising finding that the cough stress test was higher in the scissor group, even though our impression is that it's tighter. When we put it together with patient reported outcomes and the PAD test, our overall impression is that the cure rates are the same. And this was powered for superiority, and the fact that we did not really find a difference, I feel comfortable saying the cure rates are the same. So while that one parameter is higher, I don't think we should use just an intraoperative or an intra-office cough test to define cure. When we put it with the other definitions of cure, I'd say they're equal. Thank you for your study, this is very nicely done, and thank you for sharing your work. Did you collect other data on wild tensioning? Because we know sometimes you put it to type and you loosen it and you put it down. Did you collect how many times the sling was adjusted and dropped? So if a surgeon had an experience where it was over-tensioned, and in my experience this is often because the protective sleeves come off too quickly, they would re-tension using the exact same technique. It was uncommon. I think given the fact that this was a high-volume group, we rarely had situations where those sleeves got zipped off too quickly.

trial

techniques

tensioning

retropubic slings

Mayo scissors

Babcock clamp

bladder function

stress urinary incontinence

operative times

mesh exposure