The retropubic space, also called the prevesical space or space of retios, is one of the extraperitoneal surgical spaces in the pelvis. This space is filled with fatty and loose areolar connective tissue and contains important neurovascular structures. With the advent of midurethral slings, anticontinence procedures once requiring entry and direct visualization of the retropubic space have declined. As a result, pelvic surgeons are growing increasingly less familiar with the three-dimensional anatomy of this space. The objectives of this video are to describe the anatomy of the retropubic space and in this context review some surgical procedures and known complications. The retropubic space can be accessed from an intraperitoneal or an extraperitoneal approach. The extraperitoneal approach is most commonly used when performing an isolated retropubic procedure such as a burst urethropexy. With this approach, the following layers are cut. The skin and subcutaneous tissue, the anterior rectus sheath, and lastly the transversalis fascia. This space is, however, most commonly accessed from an intraperitoneal approach. With this approach, only the peritoneum is entered to gain access to the retropubic space. Between the transversalis fascia and the peritoneum lies a layer of extraperitoneal fatty tissue often called the preperitoneal fat. This layer of fatty tissue in the abdominal wall is continuous with the retropubic space. The anterolateral boundaries of the retropubic space consist of the bony pelvis and muscles of the pelvic wall. The upper border of the pubic bones, which contributes to the anterolateral surface of this space, has a ridge-like fold of periosteum known as the pectineal ligament or Cooper ligament. This structure is sometimes used to anchor sutures during urethral suspension operations such as the Bursch urethropexy, as will be shown later. The bladder and proximal urethra lie posteriorly. The posterolateral limit to this space is the attachment of the paravaginal tissue or endopelvic fascia to the archostendineous fascia pelvis and the attachment of the bladder to the cardinal ligament. These attachments separate the retropubic space from the vesicovaginal and the vesicocervical space entered during hysterectomy and other procedures. The archostendineous fascia pelvis is a fibrous band that lies on the inner surface of the obturator internus, pubococcygeus, and puborectalis muscles. It spans from a distal and more notable attachment at the lower portion of the pubic bone to its proximal attachment near the ischial spine. Important neurovascular structures encountered within this space include the dorsal clitoral vessels, which pass under the lower border of the pubic symphysis, the obturator nerve and vessels, which lie in the obturator fossa, and the vesicolvenous plexus. The obturator vessels and nerve exit the pelvis through an opening in the obturator membrane, known as the obturator canal, to supply structures in the medial compartment of the thigh. The obturator canal lies 5 to 6 centimeters from the midline of the pubic symphysis and 1.5 to 2 centimeters below the upper surface of the pectineal ligament. The external iliac vein is found approximately 6 to 8 centimeters lateral to the superior border of the pubic symphysis. Vascular connections between the external and internal iliac systems that pass over the superior pubic rami are found in 40 to 66 percent of women. These are called pubic vessels or accessory obturator branches. In the orthopedic literature, these vessels are sometimes called the corona mortis or crown of death, as injury from pelvic fractures can result in catastrophic bleeding when the vessels retract into the obturator canal within the bony pelvis. Lateral to the bladder and vesicle neck lies a dense plexus of vessels called the vesicolvenous plexus. It lies at the border of the lower urinary tract and includes 2 to 5 rows of veins that course within the paravaginal tissue parallel to the bladder and eventually drain into the internal iliac veins. The dorsal vein of the clitoris drains into this plexus. These veins of the vesicolvenous plexus course deep within the paravaginal tissue and although they bleed when sutures are placed or trochars pass in this region, this venous ooze usually stops when the sutures are tied or pressure applied. Tissues of the inferior hypogastric plexus also course through this paravaginal tissue. Rare, but potentially life-threatening complications of retropubic meat urethral sling include bowel perforation and bleeding that requires transfusion. These photographs demonstrate the passage of a meat urethral sling needle through the retropubic space in a cadaver and their relationship to the previously discussed structures. With correct placement, the trochar perforates the periurethral tissue just behind the pubic ramus and remains near the dorsal and medial surface of the pubic bone until it is passed through the anterior abdominal wall. Due to the course and variability of the vesicolvenous plexus, needles often pass near or through this intricate web of veins. As discussed earlier, this bleeding is usually transient as the veins are embedded within the paravaginal tissue and thus exist in a confined space. If profuse bleeding is noted following passage of trochars or needles, one should suspect injury to a major vessel such as the obturator or external iliac. As reported by Muir and colleagues and shown in these photos, lateral and upward deviation of the trochar or needle can lead to obturator neurovascular injury and or external iliac vessel injury. Therefore, it is vital to avoid lateral deviation or cephalodisplacement of the trochar. Lateral rotation of the trochar handle along with cephalodisplacement may result in any of these injuries. Old mesh concerns have anecdotally led to a resurgence of the Burge urethropexy. When performing this procedure endoscopically, the bladder is partially filled to better demarcate its superior border. The retropubic space is entered by making a transverse incision between the medial umbilical ligaments to enter the preperitoneal fatty layer of the anterior abdominal wall. To avoid bladder entry, the plane of dissection is maintained close to the anterior abdominal wall. Visualization of the cotton-like loose areolar tissue within the space suggests the correct plane has been entered. The dorsal surface of the pubic bone is then exposed by sharply and bluntly dissecting this tissue close to the pelvic wall. Once the archostendinous fascia pelvis is identified, dissection from the lateral pelvic wall towards the urethra is carried out in order to expose the periurethral tissue. As shown here, the index or middle finger of the surgeon's non-dominant hand is placed in the vagina, and the anterior vaginal wall is elevated in order to expose the periurethral tissue. During robotic-assisted cases, this maneuver can be done by a surgical assistant. Prior to suture placement, the urethrovesical junction is displaced to the contralateral side to avoid urethral or bladder entry. Two permanent sutures on each side are passed through the periurethral tissue and anterior vaginal wall, with care not to penetrate the vaginal lumen. These sutures are placed at the level of the mid-urethra and urethrovesical junction as per the CARE trial protocol. Both strands of each suture are then passed through the pectineal ligament approximately five to six millimeters apart, and the nuts are tied over the ligament. Although many modifications are described, we pass the sutures in a helical or double-bite fashion to secure a greater surface area of vaginal wall. The sutures are not tied down unless significant bleeding is encountered. We believe this may reduce entrapment of nerve fibers that cause through this tissue, thus potentially reducing voiding and or sexual dysfunction. Again, the sutures are passed through the full extent of the pectineal ligament a few millimeters apart. When tying down the sutures over the pectineal ligament, care is taken to not elevate the anterior vaginal wall far beyond the level of the archostendoneus fascia pelvis. The most distal suture on each side of the urethra is placed approximately 1 to 1.5 centimeters lateral to the urethral wall, and 1 centimeter distal to the urethrovesical junction. These sutures should lie just medial to the distal extent of the archostendoneus fascia pelvis. The proximal sutures are placed at the level of the urethrovesical junction, 1.5 to 2 centimeters lateral to the wall of the urethra. Procedures where the retropubic space is entered, either by direct entry or blind passage of needles or trocars, are frequently performed by pelvic surgeons. Although generally described as an avascular space, major vessels and nerves course through or lie near the space. Thus, a thorough understanding of the neurovascular anatomy of the space and anatomic relationships is essential in order to reduce injury risk and manage complications. Every single fellow paid great attention to the anatomy because you don't get to see birches I think as much anymore, maybe changing, but really fantastic. We probably have time for one question, if there are any questions or comments. Congratulations, this is fabulous work, thank you. Our next presenter will be Dr. Harvey. Paper number seven. This is the cost effectiveness of sacral neuromodulation versus Botox for refractory urgency urinary incontinence results from the Rosetta trial. I'd like to thank the Society for allowing me to present our work. Here are our disclosures. The results of the Rosetta trial have been previously published. SNM and Botox 200 units have similar efficacy through two years. However, the cost effectiveness of SNM and Botox has not been reported using within trial data. Relative cost per effectiveness and improvement in patient quality of life can help inform decisions. For example, in the UK, threshold over which treatments are less likely to be recommended is typically between 20,000 and 30,000 pounds per quality adjusted life year. In the US, there are no specific recommendations and guidelines, however, thresholds between 50 and $150,000 per quality adjusted life year are commonly used. In the Rosetta trial, 386 women with refractory urgency urinary incontinence were randomized to SNM versus 200 units of Botox and followed for two years. In the SNM group, 82% underwent implantation of the pulse generator. In the Botox group, over 24 months, 72% requested a second injection and 47% requested a third. Cost effectiveness analysis includes a Rosetta 24-month intent to treat population. For cost effectiveness analysis, you need both costs and effects. This analysis was performed from a healthcare sector perspective. The cost-reducing method was utilized, where medical costs were estimated by combining the trial healthcare utilization data with Medicare reimbursement rates or published prices. Costs were reported in US $2,017. The primary effectiveness outcome was quality adjusted life years, or QALYs, calculated from the Health Utilities Index Mark 3. Other condition-specific effectiveness measures included decrease in daily urgency urinary incontinence episodes and overactive bladder-specific quality of life, patient satisfaction, and symptom control measures. The primary cost-effectiveness outcome is the incremental cost-effectiveness ratio, or ICER, which is the ratio of the differences in cost to the differences in quality adjusted life years. We also evaluated condition-specific cost-effectiveness outcomes. To explore the cost-effectiveness of S&M versus Botox over a longer period of time, when participants on Botox therapy may require multiple reinjections, while those on S&M may have limited additional costs, we also conducted a scenario analysis, which we modeled cost-effectiveness through five years. The main characteristics of the Rosetto trial were similar between groups. There were no significant differences in effectiveness results between the two groups at two years, including quality adjusted life years, reduction in urgency urinary episodes per day, and while there were improvements in condition-specific symptoms and quality of life outcomes in both groups, there was no difference between groups. This slide presents the cost using two-year within trial data. The cumulative mean per person cost over two years were significantly higher for S&M than Botox at $35,000 versus $7,000. Costs included the treatments, clinic visits, and adverse events such as hospitalizations, UTIs, and urinary retention. Some women in the S&M and Botox groups received the alternate treatment. This slide presents the projected cumulative mean per person cost over five years. Costs continued to be significantly higher for S&M versus Botox at $36,000 versus $12,000. However, the difference between groups narrowed due to continued Botox treatments and minimal increased costs for S&M. This slide shows costs, quality adjusted life years, and incremental cost effectiveness ratio, or ICER, using the two-year within trial data and the five-year analytic model data. The two-year ICER for S&M was $1.8 million for quality adjusted life year, and the five-year ICER was $4.2 million for quality adjusted life year, both of which are significantly above the commonly used cost effectiveness threshold of $50,000 to $150,000 for quality adjusted life year. Ladder diaries show no difference between S&M and Botox in reduction of urgency urinary incontinence episodes at two years or five years. However, S&M has higher costs than Botox. Thus, at two years, S&M has a higher cost of $15 for each leak avoided compared to $275 for Botox. This reduces overtime. At five years, S&M has a cost of $6 for each leak avoided compared to $177 for Botox. Other condition-specific cost effectiveness measures also favored Botox at two and five years. This was performed to explore uncertainty in the primary estimated incremental cost effectiveness ratio and to evaluate confidence intervals of the two dimensions of cost and quality adjusted life years. This figure shows the scatter plot on the cost effectiveness plane. The Y-axis represents cost with the upper quadrants representing S&M costs greater than Botox. The X-axis represents effectiveness with the right half representing S&M qualities greater than Botox. Two-year results are in orange and five-year results are in blue. The point estimates for the incremental cost effectiveness ratios are indicated. Results are above the horizontal midline demonstrating that S&M costs are greater than Botox and results are centered around the vertical midline demonstrating that quality adjusted life years effects are not significantly different between S&M and Botox. Subsequent analysis was performed. Reduction of S&M device and procedure costs by at least 68% or increased frequency of Botox injections of 5.8 per year resulted in cost effectiveness at the $50,000 for quality adjusted life year level. In conclusion, effectiveness measures improved for both S&M and Botox and there were no differences between groups. Costs were significantly higher for S&M versus Botox at both two and five years. Cost effectiveness analysis using both quality adjusted life year and condition specific measures favor Botox over S&M at two and five years. In conclusion, S&M in its current form is not good value compared to Botox 200 units at two or five years. Reduction of S&M costs or change in technology could improve cost effectiveness. Thank you. So our next presenter is Yuko Kameso and she is going to be presenting on hypnotherapy or pharmacotherapy for urgency urinary incontinence treatment in women, the HIPHOP randomized clinical trial. Do we get music too? So hypnotherapy or pharmacotherapy for urgency urinary incontinence was our RCT funded by the National Center for Complementary and Integrated Health. These are our disclosures. Urgency urinary incontinence or UUI is a lower urinary tract abnormality of unclear etiology typically focused on the bladder. UUI patients have altered or increased sensory perception with bladder filling called hypervigilance. So our question was, what role does the brain play in this altered perception? And can a brain-focused treatment such as hypnotherapy affect UUI? Our objective was to determine the efficacy of hypnotherapy on urgency urinary incontinence compared to standard medication treatment. We compared hypnotherapy, hereafter referred to as hypnosis for brevity, to medications, the primary outcome being the number of UUI episodes on bladder diary at two months with secondary outcomes of UUI episodes on bladder diary at six and 12 months, as well as the results of validated questionnaires at similar time intervals. This investigator-massed non-inferiority randomized control trial included women with UUI randomized to hypnosis and standard education compared to extended release anti-muscarinics and standard educational counseling followed for a year. We included women with a minimum of two UUI episodes on three-day diary and excluded those with neurogenic bladder, significant prolapse, and contraindications to treatment. This intention-to-treat protocol compared groups following regression analysis with a pre-established non-inferiority margin of 5%. As we know, non-inferiority cannot prove superiority, thus we decreased alpha to .025 to allow potential proof of superiority. Sample size calculations indicated that 152 women, approximately half in each group, were required for this analysis. We randomized 152 women, 74 to hypnosis and 78 to medications, and we had primary outcome results for 142 at two-month follow-up. We were able to maintain greater than 90% follow-up at six and 12 months. Of these 142 women, there were no differences in baseline characteristics. Most were in their mid-to-late 50s, obese, with moderate to severe urinary incontinence on their incontinence severity diary, as well as a baseline of seven to eight episodes. Please note the last row, which represents hypnotic susceptibility testing. We performed hypnotic susceptibility testing prior to randomization, and investigators were masked to these results until study end. Women who were in the low hypnotic susceptibility group at 93% were in the medium-to-high group. This slide of the raw results, meaning the unadjusted median UUI episodes on three-day diary, encapsulates the crux of the study findings. Hypnosis did effectively treat UUI. At baseline, hypnosis, represented in red, had eight episodes, medication seven. At two months, hypnosis decreased to two episodes and medications to one. At six months, both had one episode on three-day diary, and this was sustained at 12 months without differences between groups. However, regression analysis indicated a three-way interaction, meaning the UUI results differed depending upon baseline UUI, hypnotic susceptibility, and the follow-up time intervals. We were unable to prove the non-inferiority of hypnosis at any of the time intervals. Thus, the subsequent slides represent the superiority findings. We divided patients into low, medium, and high hypnotic susceptibility groups. The y-axis represents UUI episodes, the x-axis time, in this slide, the two-month follow-up. The red results are hypnosis results, and the black lines are the medication results. We were unable to find or prove superiority for either medications or hypnosis at this time interval. At six months, in the medium hypnotic susceptibility group, hypnotherapy was superior to medication medications, meaning the red dot is below the black dot. At 12-month follow-up, we were able to prove the superiority of hypnotherapy in the high hypnotic susceptibility group. Questionnaire results all improved from baseline to follow-up. There were no differences between groups, and changes exceeded the minimally important difference for most of the questionnaires, albeit not all. Compliance did not differ between groups. So in summary, hypnosis did not meet non-inferiority parameters at two months, but was superior at six and 12 months in the medium and high hypnotic groups, respectively. But importantly, both hypnosis and medications efficaciously treated UUI at all follow-up. Heavy weaknesses included are better than anticipated efficacy in the comparator group, in this case medications, making it difficult to satisfy the 5% non-inferiority margin. Strengths included is randomized trial design, use of a novel mind-body intervention with good one-year follow-up and compliance. So both hypnotherapy, a mind-body intervention, and medication efficaciously treated UUI for up to one year. Acceptance that the mind plays a significant role in UUI may expand our understanding of it as well as expand its treatment horizons. Thank you, and I look forward to questions. Hi, Ibu Versi, really fascinating. What do you actually do during the hypnosis? That was my question. I mean, do you say you will not feel urgency anymore? No, but more seriously, how easy is it to learn to do this? Because if this is real data, it's wow. I've learned a lot about hypnotherapy. Our trial involved six clinical hypnotherapists that are certified. That means they have to go through educational sessions to receive 300 hours of training clinically in order to be clinical hypnotherapists. One of our co-i's is a hypnotherapy instructor at the institute that we have in Albuquerque, and it was a very standardized two-month session. After listening to hypnotherapy tapes, because we audited all of them, it's sort of like having meditation on steroids. The first session was education and relaxation, followed by individual sessions. Interestingly, the sixth session was fascinating. It was regression, where women were asked, what about your UUI episodes make you think about the first time you felt that way? It really is therapy. I can't explain how well the patients responded to this intervention. The question is, are there certified hypnotherapists in your neighborhood? There are quite a few hypnotherapists throughout the country, so it is, if insurance would pay for it, I believe it would be an effective treatment. Yuko, as a follow-up, what percent breakdown are people in terms of their susceptibility to hypnosis? Are most people high susceptibility, or medium, or low? Is this pretty reflective of the population? How do they test for that? Yeah, ironically, when I saw this test, which is called the Stanford Group Testing for Hypnosis, it's old, it's 30 years old, 40 years old, I did not believe that it would have any effect. They ask questions like, do they head nod? Do they lift their arms when they're told to lift their arms under hypnosis? So there are actually very few data about how this really comes out in clinical trials. This is one of the first ones, and I was fascinated that it actually did make a difference. In terms of the generalizability, we don't know what hypnotic susceptibility is in the generalized population or in the UUI population. We have a question in the far back, and then we might go to the front here. Yeah, thank you. I'm from New York. Thank you very much. It was an excellent study. I guess my question is, as we all know, pharmacology, one of the issues that patients stop taking medication for UUI is adverse events, adverse side effects. So if they were both efficacious at six to 12 months, I guess my question is, were there any adverse events or side effects from the hypnotherapy group? Actually, there were no differences in adverse events as defined very, very broadly, meaning a patient would say, I tripped over a rug yesterday. We captured all of those, and there were no differences between the hypnosis and the medication groups. But with respect to the adverse events that were expected with medications and predefined GI side effects, dry eyes, et cetera, there was a difference between the anticipated events. Because hypnotherapy, the only event that we could really think of was severe emotional upset, and no one had that. But I believe that, oh, geez, something like 30 of the patients in the medication group did have the expected adverse events. Unfortunately. Sorry, we're out of time now, so we're going to have to move on. Thank you so much. Thank you. Thank you. Next, we have Dr. Lauder presenting bladder health terminology, proposed definitions for women and girls. On behalf of my co-authors and the entire Prevention of Lower Urinary Tract Symptoms or PLUS Research Consortium, I'd like to thank the scientific committee for inviting us to present our work. These are our disclosures. The PLUS Research Consortium is supported through NIH-NIDDK cooperative agreements. To date, bladder function has been defined through the presence or absence of lower urinary tract symptoms, or LUTs, rather than indices of bladder health. In addition, women are at high risk for specific lower urinary tract symptoms than men. So prevention of LUTs and promotion of optimal bladder health function is particularly important for women and girls. The PLUS Research Consortium was established in 2015 with a mission to identify bladder health as a state to preserve and protect, and expand research in the area of clinical practice on policies that impact bladder health, and move research beyond the detection and prevention of LUTs to the promotion and preservation of bladder health and prevention of LUTs in women and girls. Normative data have been published for certain bladder function measurements in women. However, the study populations are typically described as normal, healthy, or asymptomatic. Descriptions of health are based on the absence of one or more LUT symptoms, and absence of LUTs may not necessarily equate to healthy function. Consistent with the World Health Organization's definition of health, the PLUS Research Consortium conceptualized and defines bladder health as a complete state of physical, mental, and social well-being related to bladder health function, and not merely the absence of LUTs. The objective of this PLUS research work was to develop research definitions for assessing the full spectrum of bladder health, from bladder health to dysfunction across the female life course. A subgroup of PLUS investigators formed the Terminology and Conceptual Framework and Models, or TCFM, intellectual resource group. After development of the bladder health definition, TCFM members developed and refined terminology and definitions for elements of healthy bladder function related to storage, emptying, and bioregulatory functions. A broad review of the literature confirmed the absence of bladder health definitions or healthy bladder functions. Published LUTs definitions provided starting points for bladder health function definitions. Our goal was to develop bladder health definitions that could be organized, compared, and displayed in a parallel fashion to existing International Continence Society-defined lower urinary tract symptoms. Terms and definitions were developed based on the two-phase concept of bladder function, storage and emptying, described by Wien. A novel concept of bioregulatory function was included to recognize that the bladder lining and urine composition may play a role in bladder health and lower urinary tract symptoms. Definitions were revised in an iterative process over a 14-month period. These definitions include overall definitions of storage, emptying, and bioregulatory functions, with seven elements of storage-related definitions, seven elements of emptying-related definitions, and three elements of bioregulatory definitions. Our terminology table is structured so that bladder dysfunction, or LUTs, and bladder health are displayed in parallel. Bladder function included storage, displayed in yellow, emptying in green, and bioregulatory in pink. The column of elements of function was developed so that the bladder dysfunction and bladder health functions, again, could be displayed and compared in parallel. Each bladder health definition is completed with a qualifying statement noted by the asterisk and does not impact daily activities on a routine basis, is adaptable to short-term physical or environmental stressors, and allows pursuit of optimal well-being. An example of an element of function is capacity-frequency day waking and capacity-frequency night sleeping. We included capacity and frequency into the same element of function. These are often dependent. In addition, definitions to date divide LUTs frequency into daytime and nighttime. We added waking to daytime and sleeping to nighttime, as nontraditional work and social circumstances may make existing definitions less clear. An example of a storage function bladder health definition is sensation urge. With the bladder health definition, the awareness and sensation of urge in bladder fullness that allow sufficient time to get to the toilet facilities without fear of leakage. The corresponding LUTs definition is the ICS term urinary urgency, which is the sudden compelling desire to pass urine that is difficult to defer. To further characterize the LUTs sensation urge, PLUS developed in absence of urge terms the lack of sensation at full capacity. An example of an emptying function bladder health definition is stream flow speed. With the bladder health definition, voiding occurs in amount of time that does not impact daily activities. The corresponding LUTs ICS term is slow stream. An example of a novel bioregulatory function definitions of bladder health is of the biosis barrier. The bladder health definition is a healthy relationship symbiosis between host and bladder microbiota. For all the bioregulatory section definitions, LUTs related definitions were developed by PLUS as well. The strength of these definitions are that they were developed by a transdisciplinary group after a thorough literature review and in an iterative process. These definitions correspond with the existing bladder function and LUTs definitions, and they incorporate emerging bladder concepts, specifically the bioregulatory function. Limitations are that they were developed by a single group from a single English-speaking country, and these definitions may not be applicable to clinical or community practice. And we recognize that ongoing review, refinement, and definition development, not only by our group, but potentially outside groups, is not only anticipated, but essential to widespread acceptance and use. So in conclusion, the proposed plus bladder health research terminology and definitions represent a transdisciplinary approach to standardizing definitions for the elements of bladder function from a perspective of bladder health rather than dysfunction. And they provide a framework of bladder function and definitions for research into to study clinical practice, public health promotion, and LUTs prevention. While we do not expect these research definitions will be embraced by all members of the medical and scientific community, plus is using these definitions to further our bladder health promotion and LUTs prevention research agenda. Currently, these definitions are being used to develop novel instruments to measure bladder health across a broad socio-demographic spectrum of women and girls. These are our research centers and investigators, and I look forward to your questions. Thank you. Okay, our next presenter is Dr. Cooper, presenting Evaluating Asymptomatic Microscopic Hematuria in Low-Risk Women, a Cost-Effectiveness Analysis. Thank you for the opportunity to present our work. Our study is entitled Evaluating Asymptomatic Microscopic Hematuria in Low-Risk Women, a Cost-Effectiveness Analysis. We have no disclosures. Asymptomatic microscopic hematuria, or AMH, is common, occurring in up to 40% of adults. Even a single episode may indicate urinary tract malignancy, or UTM, which in this presentation refers to transitional cell and renal cell carcinomas. The American Neurological Association guidelines recommend that all adults over age 35 with AMH undergo evaluation with CT urogram and cystoscopy. The benefit of this strategy is maximizing UTM detection. The risks include harms of diagnostic workup, as well as cost. This algorithm is largely based on studies involving men, does not reflect newer population-based data on UTM incidence, and may be overly aggressive for groups with a lower pretest probability of UTM. In 2017, ACOG and AUGS together released an alternative recommendation that women ages 35 to 50 with 25 red blood cells per high-powered field on microscopy, with no smoking history or other risk factors, should have no evaluation for UTM. This cohort has an estimated UTM incidence of less than 0.4%, based on two population-based studies listed here. The benefit of this strategy is reduced risk and cost of workup. The risk is missed UTM diagnosis. Another alternative, advanced by some studies and used as part of the national testing algorithm in Canada and the Netherlands, is retroperitoneal ultrasound and cystoscopy. The benefit of this approach is reduced harm and cost of diagnostic testing, and the risk was a small decrease in diagnostic accuracy. The goal of our study was to compare the cost-effectiveness of these three algorithms among women meeting the ACOG-AUGS criteria, who we'll refer to as low-risk. We also ran a secondary analysis among all women. Cost-effectiveness analysis compares the relative costs and effects of different courses of action. In a CEA, we rank order strategies by increasing cost and calculate an ICER, or incremental cost-effectiveness ratio, between each pair. This is the ratio of the incremental increase in cost between two strategies divided by the increase in effect. For our three strategies, we calculated two ICER results. We designed a decision analytic model from the healthcare sector perspective. Inputs are based on the literature. The macro costing approach was used with medical costs estimated by combining model healthcare utilization data with Medicare reimbursement rates or published prices. Costs include medical utilization during the diagnostic period and additional long-term costs. Results are in 2018 U.S. dollars. Analysis was performed using the R programming language, effects assessed for UTM detection, and we also performed uncertainty and threshold analysis to test stability of the outcomes. This is a simplified view of our model. For ACOG-OGS, the cost was of delayed cancer diagnosis. We assumed that cases would proceed from localized to metastatic disease. For CT-SYSTO and ultrasound-SYSTO arms, the model incorporates diagnostic testing and accuracy, confirmatory testing, as well as harms such as sequelae of radiation exposure, contrast-induced nephropathy or CIN, and incidental findings. To provide context beyond our cost outcomes, we calculated predicted incidents of harms from testing. For 10,000 women, we would expect 400 cases of CIN, 3,300 incidental findings, and eight deaths due to cancer associated with CT scan radiation exposure. In CEA, uncertainty analysis is used to broadly summarize our results and to depict the equivalent of a two-dimensional confidence interval for each of the two ISER results. This graph compares ultrasound-SYSTO in yellow against a reference strategy of ACOG-OGS at the origin. The y-axis represents cost, with upper quadrants representing increasing cost, and the x-axis represents effectiveness, with the right half being more effective than the left. This demonstrates that ultrasound-SYSTO detects more UTM at higher cost than ACOG-OGS. This graph depicts the uncertainty for CT-SYSTO in blue compared with ultrasound-SYSTO at the origin. Here, results are well above the horizontal midline, demonstrating substantially higher cost. However, they hover around zero on the x-axis, demonstrating slightly increased versus equivalent effectiveness in UTM detection for this low-risk cohort of women. For our low-risk cohort, the lowest-cost strategy with ACOG-OGS, with a cost of $3.2 million per UTM detection, pardon me, per 10,000 women, and 30 delayed UTM diagnoses. Ultrasound-SYSTO detected 28 additional UTM with an ISER of $491,000, meaning that it cost an additional $491,000 per additional UTM detected. CT-SYSTO was not cost-effective compared to ultrasound-SYSTO. It detected an additional 0.25 cases of urinary tract malignancy per 10,000 women at a cost of $44 million. Yet, CT-SYSTO still missed one UTM among that cohort of 10,000 women. When we first excluded harms of testing, and second, both excluded harms and assumed perfect diagnostic accuracy, both ultrasound-SYSTO remained cost-effective over CT-SYSTO. For threshold analysis, we tested the model against different hypothetical rates of UTM incidence and other factors. For instance, when run with all women for secondary analysis, or a UTM incidence of 0.4%, ultrasound-SYSTO remains cost-effective over CT-SYSTO. There are several limitations to our study. Our model relies on published data. Our incidence data may underestimate UTM because not all patients had a complete workup via the AUA guideline. We used a limited duration of follow-up. UTM rates do vary geographically. And finally, we did not convert our outcome to quality-adjusted life years, or QALYs, which would enhance generalizability to some other studies. In conclusion, the AUA guideline of CT-SYSTO is not cost-effective among women and is overly aggressive for all but the highest-risk women. The alternative of ultrasound-SYSTO is cost-effective relative to CT-SYSTO and may be more appropriate for many women. And ACOG's recommendation of no workup for low-risk women is cost-effective but misses 30 cancer diagnoses per 10,000 women. Creation of age- and sex-specific guidelines with clear follow-up criteria could improve safety and decrease cost for women with AMH. Thank you. We look forward to questions. Thank you. And it's certainly something that we struggle with all of the time. For sure. When you used this data, it was all asymptomatic, microscopic hematuria that we were sure that they weren't picking up UTIs and that kind of thing. Sometimes dealing with this big data, you can't exclude the UTI people. That is for sure true. There are two different data cohorts on which we based this estimate for the low-risk women. And they included thousands and thousands of women. And so for several of them, they weren't definitely able to rule it out. And so there is a small possibility that there were UTIs included. But if anything, that would make our ISER results and the cost-effectiveness even higher. Perfect. Thank you. I'm Mitch Schustrom in North Alabama. Very nice study. Thank you. Regarding cost, and you're looking at your CMS database, are you using facility or non-facility? And was your diagnosis only for facility or non-facility hematuria? We tried to estimate based on common office practice of our urology colleagues, who are, of course, the experts in workup, what many urologists perform in their offices versus in the hospital in terms of selecting the facility versus non-facility cost. We also tried to average across geographic locations to make the estimate more generalizable to the country. Thanks. And do you have an intent to present this data in a urology forum? I certainly hope so. And we're looking forward, actually, to the input and feedback of urologists, knowing that this is newer data than when the AUA guidelines came out and that it was mentioned in the AUA guidelines very explicitly that it could be desirable to have subgroup algorithms, but that there did not exist adequate population-based data at that time. We hope that this contributes to a sense of growing urgency that we need to address this on the more rapid side because there are real harms as well as cost harms with leaving it at the current state. And we also hope there is great literature that has come out, particularly from Kaiser Permanente of Southern California, which facilitated us making these estimates, empowering us as OBGYNs who are women's health advocates to cite ACOG's and that committee opinion and to know the data out there as we try to have a more nuanced approach to our own patients. And I think we have time just for one quick question. Lindsey Kerr, Eastern Maine Medical Center. So as a urologist and FPMS, this is very helpful for us. And I had two questions for you. One was you had put down other risk factors, and if you could outline a little bit where one would find what those other risk factors would be of concern. And the second was if you were to use a group that was cystoscopy alone without ultrasound, would that separate out in any way? I'm going to let you answer one of those because we are over time. So I think I'd rather answer the cystoscopy question. Well, I'm happy to do either one, but I think it's more impactful. In general, there's ten times as many bladder cancers as ureteral and upper tract, ureteral and renal cell carcinoma. So although we are having such a big debate over what to do with the CT scans, in fact our already low percentage of urinary tract malignancies among women, one-tenth of that is going to meaningfully be detected by the CT scan that's causing so much cost and risk. And so there are some cost-effectiveness analyses. For instance, one done by Halpern last year in Annals of Internal Medicine that looked across all adults and did include cystoscopy as one of the options. That's a great suggestion, and perhaps in another iteration of this, before we publish it, we could consider adding it. And I think, if anything, that would make it more cost-effective. Thank you. Thank you. Really appreciate it. Good discussion. That's great. Our next speaker is Dr. Lavelle, who will be presenting Nitrofurantoin prophylaxis in women undergoing catheterization for acute postoperative urinary tension after pelvic reconstructive surgery, a randomized double-blind placebo-controlled trial. Thanks for reading that very long title. And on behalf of myself and all of our authors, we'd like to thank the Scientific Committee for the opportunity to present this work. These are our relevant disclosures. This research was generously supported by the Fellows Pelvic Research Network. So the incidence of urinary tract infection after prolapse or incontinence surgery approaches 40 percent, depending on the definition. This risk is increased in women with postoperative urinary retention requiring catheterization, which leads many providers to prescribe prophylactic antibiotics during catheterization. However, minimal Level I evidence supports or refutes this practice, and existing trial-level data is limited by outcome definition, which often includes asymptomatic bacteria or empiric treatment of urinary tract infection symptoms. Our primary aim was to determine if Nitrofurantoin prophylaxis was the incidence of symptomatic, culture-documented UTI among women with postoperative urinary retention following prolapse or incontinence surgery. This was a multi-centered, double-blind, placebo-controlled, randomized trial performed from 2016 to 2018 in five academic fellowship programs of FPMRS. Women were eligible if they underwent surgery for prolapse or incontinence and had postoperative urinary retention defined by a post-void residual volume of 100 cc or greater. Women were randomized to Nitrofurantoin 100 mg or a matching placebo pill taken daily during catheterization. They were randomized in a one-to-one ratio, and patients were discharged with indwelling or, excuse me, the randomization was stratified by site, excuse me, and patients were discharged with indwelling versus intermittent catheterization at the discretion of the surgeon, with steady staff, clinical staff, and patients blinded as to allocation. Women were excluded if they had an allergy to Nitrofurantoin, renal insufficiency, recurrent urinary tract infections or history of renal transplant, nephropathy, or any known immune compromise. The primary outcome was incidence of symptomatic, culture-documented urinary tract infection within six weeks of surgery. Patients self-reported urinary tract infection symptoms, which were then evaluated by urine culture. Urine culture was considered positive if there were, what, 1,000 or more colony-forming units of a single species of bacteria. Several measures were undertaken to ensure accurate measurement of the primary outcome. So patients were given strict instructions to report UTI symptoms to their study physician and to avoid empiric treatment. They were given direct contact numbers for the study fellows and a prescription for a urine culture prior to discharge. At the six-week follow-up visit, study staff also confirmed that there were no other otherwise unrecorded episodes of urinary tract infection symptoms during the study period. Secondary outcomes were adverse symptoms possibly attributable to Nitrofurantoin exposure, which was recorded by patients in a daily diary, and culture isolates with resistance or intermediate sensitivity to Nitrofurantoin. Per-protocol analysis was limited to patients who were adherent with study medication, received no additional antibiotics during the study period, and for whom a UTI diagnosis was documented by culture. We calculated that 154 patients would be needed to detect a reduction in UTI incidence from 33% to 13% with 80% power and a two-sided alpha of .05 allowing for dropout. 439 patients were assessed for eligibility, and 154 were randomized equally between the two arms. There were 75 patients in the antibiotic arm and 76 in the placebo arm available for the intention to trade primary analysis. There were no differences in baseline demographic data between the groups. Indication for surgery and catheter type were equally distributed between the two arms. Median duration of catheter use was four and three days with no statistical difference between the two groups. For the primary analysis, there were 13 patients in each group, or 17%, who experienced a urinary tract infection within six weeks of surgery with no statistical difference between the groups. When analysis was stratified by catheter type, there was still no difference in the incidence of urinary tract infection between the two groups. Of the 151 women in the primary analysis, 87 were eligible for per-protocol analysis, 41 in the Nitrofurantoin arm, and 46 in the placebo group. In the per-protocol analysis, six women in the antibiotic arm and four in the placebo arm experienced a urinary tract infection, again with no statistical difference between the two groups. There were 55 total episodes of urinary tract infection symptoms reported. 52 of these were evaluated by urine culture. Of those, urine culture was confirmed for only 27, or 52%, of those episodes, and the remaining cultures were negative. These 27 positive cultures were analyzed for Nitrofurantoin resistance. Four cultures in the Nitrofurantoin group and three cultures in the placebo group identified resistant or intermediate sensitivity isolates to Nitrofurantoin with no statistical difference between the groups. Adverse symptoms possibly attributed to Nitrofurantoin were reported at high but equivalent rates between the two groups. However, constipation was reported twice as frequently in the antibiotic group as compared to the placebo group. Strengths of the study include the study design and generalizability, as well as the symptomatic and culture-documented outcome definition. The limitations of the study are that we're not powered to detect differences in the stratified analysis or in rates of antibiotic resistance between the two groups. In conclusion, Nitrofurantoin prophylaxis did not reduce incidence of urinary tract infection among women with urinary retention after prolapse or incontinence surgery and a median of four days of catheter use. And while 26% of women reported urinary tract infection symptoms within six weeks of surgery, urine culture was positive for only 52% of those episodes. Thank you very much and I'd welcome any questions. Our next presenter is an award-winning Best Resident Fellow paper. The paper is entitled Outpatient Visits vs. Telephone Interviews for Postoperative Care, a Randomized Controlled Trial, and will present your award after your presentation. Thank you very much for this opportunity. These are our disclosures. Healthcare in the U.S. faces many challenges. To balance high-quality care with cost, the term value is often used to assess the healthcare system where value equals quality divided by cost. For our study, we focus on healthcare quality. Quality includes increased patient satisfaction, improving clinical outcomes, and decreasing adverse events. Routine postoperative clinic visits are based on historic norms. However, the necessity and quality of these visits are unknown. Observational studies describe practices where telephone calls have replaced clinic visits in other specialties. Telephone follow-up provides safe, effective care with high satisfaction. However, these studies used non-validated questionnaires and were limited to outpatient surgeries. We conducted a randomized controlled non-inferiority trial comparing telephone calls versus outpatient clinic visits. Our objectives included the following. The primary objective was patient satisfaction. Our hypothesis was that telephone calls will result in non-inferior satisfaction scores. For our secondary outcomes, these were safety and clinical outcomes. Our hypothesis was telephone calls will have no difference in these measures. The Surgical Consumer Assessment of Health Providers and Systems Questionnaire, also known as SCAPS, was developed by the Surgical Quality Alliance through the American College of Surgeons. This questionnaire is provided by the AHRQ and is the current gold standard for evaluating postoperative satisfaction. It is divided into seven composites to determine the patient experience. For this study, we focused on the composite called Overall Surgeon Rating. Our power calculation was based on the SCAPS Surgeon Rating from 0 to 10. The non-inferiority limit was set at 15%. Our sample size calculation gave us 100 patients in total, 50 in each group, for an intention-to-treat analysis. Patients were assessed for eligibility. 103 patients were eventually randomized into either clinic visits or telephone calls at the time of discharge. Patients had scheduled follow-up at three time points by either a phone call from a registered nurse or in the clinic with a provider. Both the phone and clinic encounters used scripted questionnaires. 50 patients in each group were included for the final analysis. This chart is a summary of our patient demographics. I want to highlight our patients who are middle-aged, Caucasian, and living on average 76 miles one way from the surgical facility. There is no difference between study groups. Patients were randomized to either clinic or telephone calls. at the time of discharge after surgery. This chart describes the types of surgeries among the randomized patients. There was a wide range of surgical procedures from mid-urethral sling placement to laparoscopic psychococopexy and everything else between. There is no difference in surgical procedures between the two randomized groups. The primary outcome was patient satisfaction defined by the S-CAPS questionnaire using the question rate your surgeon from 0 to 10 with 0 being the worst and 10 being the best possible surgeon. The headings of this chart in dark red include the randomization groups, clinic and telephone, and the p-value. The composite of the S-CAPS questionnaire surgeon rating showed that 92% of the clinic patients and 88% of the telephone patients rated their surgeon as top box, meaning they marked either 9 or 10 out of 10. Our telephone group scored within the non-inferiority limit, giving a p-value less than .025. Therefore, telephone follow-up is non-inferior to clinic follow-up for surgeon rating. The other six composites of the S-CAPS questionnaire are listed in the left column. All of these composites are significant, meaning non-inferior, except for post-op communication. This is most likely because the question asked the patient, my surgeon communicated well with me after my surgery instead of my healthcare team communicated with me. This question was not applicable to patients in the telephone group, as they mostly communicated with the nurse over the phone instead of directly with their surgeon. A secondary outcome was adverse events. There were 26 total adverse events, 15 in the clinic group and 11 in the telephone group. There was no difference between our groups, with the majority being UTIs. Another secondary outcome was categorized as additional visits. First, we looked at the number of visits to the Urogyne clinic. The clinic group returned for 147 total visits. Patients randomized to the telephone group were invited to return to clinic at any point during their care if they had a concern or if they even desired a follow-up with their surgeon. There were 35 total clinic visits by patients in the telephone group. Second, we looked at the number of visits from different providers outside the urogynecology office. In the clinic group, 8 emergency visits and 5 primary care visits were reported. In the telephone group, there were 3 emergency visits and 4 primary care visits reported. Telephone postoperative care did not increase the frequency of outside care in the ER or primary care office. The limitations to our study include the following. There is a selection bias in patients willing to receive telephone follow-up. There is a ceiling effect to the S-CAPS questionnaire. And there is heterogeneity in the type of surgical procedures that were included for this study. A strength of this study is its novel approach to postoperative care and its thorough assessment of healthcare quality in the postoperative setting. This study also utilizes the S-CAPS questionnaire, which is AHRQ's gold standard for post-op satisfaction. This study is also generalizable to a wide range of patient qualities and surgeries providing adequate service with high satisfaction for patients who may live far away, are unable to take time off work, or other circumstances that are barriers to returning to clinic. In conclusion, patient satisfaction with telephone follow-up is non-inferior to outpatient clinic visits, and there was no difference in safety or clinical outcomes. Therefore, we found urogynecologic patients can be given the option for their postoperative care. Thank you very much. All right, we'll have the last presentation of this session. So Dr. White will be presenting paper number 39, a late-breaking abstract, a prospective parallel cohort multicenter study of the SOLIX single-incision sling system versus objects to sling system for the treatment of women with stressed urinary incontinence, three-year results. On behalf of my co-authors, we would like to thank the scientific committee for allowing us to present our work. Here are our disclosures. Of note, this is a 522 post-market study that was funded by Boston Scientific. This work was completed by co-investigators at 21 sites over 36 months, and I'd like to formally thank them for their involvement. Urinary incontinence affects up to 35% of adult women, with a significant number having severe symptoms. This represents a significant burden to the health care system. For women with stress incontinence, the aminorhethral sling is the recognized gold standard treatment. Objects 2 is a traditional outside-in obdurator sling. A randomized control trial with 12 months of follow-up showed cure rates of approximately 81%. SOLIX is a single-incision sling cleared through the FDA's 510K process. Short-term retrospective follow-up showed cure rates of approximately 90%. Under Section 522, the Food and Drug Administration can mandate post-market surveillance for safety and efficacy in Class 2-3 devices. If failure would be reasonably likely to have serious adverse health consequences, or if the device is intended to be implanted in the body for longer than one year. The objective of our study was to compare a single-incision sling SOLIX to a standard outside-in trans-obdurator tape, Objects 2, for the treatment of female stress incontinence. We hypothesized that the SOLIX would be non-inferior to the Objects 2 in efficacy and safety. This was a prospective, non-randomized, parallel cohort study across 21 sites. Surgeons were assigned to either the Objects 2 or the SOLIX, and study centers were selected based upon device experience. Surgical procedures were standardized for uniformity, and concomitant procedures were allowed. Patients were followed for 36 months. Enrolling sites are shown here. Patients were eligible for enrollment if they had stress-predominant urinary incontinence, a normal bladder capacity, and a residual of 150 milliliters or less. Patients were excluded if they were planning pregnancy, had any prior stress-predominant urinary incontinence surgery, if they had an A1c greater than 7%, and if they were non-English speaking. The follow-up schedule is listed here. Patients were followed at two weeks with a phone call, and then at six weeks, six, 12, 18, 24, and 36 months in-person visits. A public exam and multiple quality of life instruments were administered at all time points. Primary endpoints shown here was a composite measure, which involved an objective negative cough stress test with a filled bladder per protocol and self-reported improvement in stress incontinence via the PGII. The secondary endpoints are shown here. They included adverse events, pain scores, subjective improvement, and re-intervention. This was a planned non-inferiority design. Given a non-inferiority margin of 15% for primary efficacy and a non-inferiority margin of 10% for safety, 140 subjects in each group were needed. A 20% attrition rate was projected over a 36-month trial period. Propensity score stratification was used to balance baseline characteristics between the groups, and intent-to-treat analysis and protocol analysis were performed. Enrollment and follow-up are shown here. 331 women were screened, 291 enrolled. Of the 141 patients that underwent SOLIX and 140 that underwent OBDRIX, approximately 70% were available for 36-month evaluation. On the demographic slide, you can see that on average our patients were about 48 years young with a BMI of 29 and predominantly white. The majority underwent concomitant procedures, as you can see here. Perioperative variables are shown. Blood loss, time to spontaneous void, time in the hospital were similar between groups. There was noted variability in longer operative time in the SOLIX group. The primary endpoint, treatment success at 36 months, are shown here. Subjective success was equivalent, both in the intent-to-treat analysis and in the protocol analysis. Success rates of 88% to 89% are seen in patients who completed 36 months of follow-up. On subjective success, there was no difference in subjective success, either with the intent-to-treat analysis or protocol analysis. Among patients who completed the follow-up, subjective success approached 95% in both groups. Pain scores are shown here. Baseline pain scores appeared to be higher in the OBD-II group. At hospital discharge, there was no difference from baseline between the two groups. By two weeks, pain scores had returned to baseline, and by six weeks, pain scores were actually improved from the baseline. When we had a look at adverse events, there was no difference in mesh-related complications, persistent urinary incontinence, infection, or pain between the groups. Here we're looking at re-surgery. There was no difference in re-operation between the two groups. The re-operations here, two in the SOLIX arm and three in the OBD-II arm, were return trips to the OR for mesh-related complications. The strengths of our study include 36 months of follow-up with enrollment sites across both academic and non-academic sites. This improves the generalizability of our study. Limitations include a lack of randomization, although we balanced this with propensity scoring. Additionally, there was some attrition over 36 months, as one might expect, and we believe that concomitant procedures may have confounded the data in part. In conclusion, SOLIX single-incision sling is non-inferior to the OBD-II trans-obdurator sling for long-term treatment success of stress urinary incontinence. The rates of serious adverse events following single-incision sling were non-inferior to adverse events following trans-obdurator sling, and this demonstrates that longer-term advocacy and safety data are now available on single-incision sling to support more minimally invasive surgery for stress incontinence. Thanks. This paper now is open for discussion and questions, and just so you know, we only have eight minutes until the next session starts, so we'll keep it to just a couple questions. A couple questions. Hi, Cedric Oliveira, New York. Thank you very much, Dr. White. That was a great study. My question is, you used the post-void residual volume in your inclusion criteria of 150 cc, and therefore I was wondering why you picked that as opposed to 100, and then my other question was, how did you define urinary retention in the two groups? So the question is, why did we use a post-void residual of 150 milliliters as an inclusion criteria? We looked across data and really tried to come up with what we thought would be an adequate emptying definition, and we used also in there two-thirds of voided volume, and so we used that as a cutoff based upon what we thought were norms for bladder capacity. And urinary retention, how did you define that post-op? Urinary retention post-operatively was defined as any residual that was higher than one-third of the total bladder volume. Thanks. Okay, I think that this will end the session. Thank you so much for your attention and your questions.

women's urological health

retropubic space

surgical procedures

hypnotherapy

pharmacotherapy

urgency urinary incontinence

cost-effectiveness

asymptomatic microscopic hematuria

postoperative care

SOLIX single-incision sling system

Objects 2 sling system