Transvaginal Bladder Neck Closure, a video production from the Division of Female Pelvic Medicine and Reconstructive Surgery at University Hospitals Cleveland Medical Center. Etiologies of neurogenic bladder originate from pathologic lesions that develop in the central and or peripheral nervous systems. Neurogenic bladder is managed by a multitude of interventions that may include chronic Foley catheterization, among others. Chronic catheterization has inherent risks that include progressive upsizing, leakage, infections, stones, risk of malignancy, and bladder neck and urethral erosions. The purpose of this video is to demonstrate a step-by-step approach of a transvaginal bladder neck closure for patients with neurogenic bladder that have developed urethral erosion from chronic Foley catheterization. The patient presented is a 49-year-old with a complex history of Guillain-Barré with persistent neuropathy and neurogenic bladder with clotting disorders complicated by Coumadin skin necrosis. She has had a Foley catheter for over two years that required upsizing due to persistent leakage and expulsion of the catheter. Her physical exam was significant for multiple skin erosions from Coumadin necrosis and urethral erosion. After the patient was counseled, the decision was made to perform a transvaginal bladder neck closure. Step 1. Given a patent eroded urethra, a Lowsley retractor is used. An incision is made two finger breaths behind the pubic bone to level the fascia. The Lowsley retractor is introduced and the 20 French Foley is grasped with the Lowsley and pulled through. This step enables urinary diversion given the planned bladder neck closure. Step 2. As seen in the video, a patent urethra is visualized to the level of the bladder neck, the narrowing. The urethra easily admits the circumference of the finger and is four centimeters long. As in the drawing, two incisions are outlined, an inverted U around the urethra and an inverted U over the anterior vaginal wall. Step 3. Once outlined, the planned incisions are hydrodissected using lidocaine with epinephrine. Step 4. We begin with an inverted U incision over the anterior vaginal wall. Once incised with a scalpel, Alice clamps are placed for counter traction and sharp dissection with meds and mom scissors is used to mobilize the anterior vaginal wall from the overlying urethra. The dissection is carried out to the level of the bladder neck to create the inverted U flap. Step 5. With the vaginal wall mobilized, an inverted U incision is made around the urethra with a fine tip bogey. Sharp retropubic dissection is performed with meds and mom scissors to the level of the endopelvic fascia to mobilize the urethra. Once the endopelvic fascia is perforated, the meds and mom scissors are spread to increase the size of the opening of retzius space. Contralysis with a fine tip bogey is further performed unilaterally to mobilize the urethra on the ipsilateral side. Once sufficiently mobilized, unilateral blunt dissection is performed by hugging the posterior aspect of the pubic bone to free the urethra from its retropubic attachments. The same steps are performed on the contralateral side. Again, sharp retropubic dissection is performed with meds and mom scissors to the level of the endopelvic fascia. Once the fascia is perforated, the scissors are opened to increase the size of the opening of the retropubic space, and urethralysis is further performed to mobilize the urethra on the ipsilateral side. The perivesical fat is visualized when the urethra is sufficiently free and mobile. At the end of the dissection, blunt dissection is again performed to free the urethra from its retropubic attachments from 9 o'clock to 3 o'clock. Once completely mobilized, the urethra and bladder are free from their retropubic attachments. Step 6. Once mobilized, the urethra is bisected to facilitate excision. It is then cut off at the level of the bladder neck. Step 7. The bladder neck is then closed in two layers. We use an interrupted 3-ovicral suture for the first layer, and an interrupted 2-ovicral suture for the second imbricating layer. Step 8. Finally, the anterior vaginal wall is reconstructed by suturing the previously created inverted u-flap to the defect created by the newly excised urethra. The defect from the urethral excision is approximated from side to side to close this space. In some cases, a martious labial fat pad may be mobilized prior to closure to facilitate healing. Six weeks after surgery, the suprapubic catheter was changed. The vaginal incision was healing well. The patient did not have any vaginal leakage. Thank you to the program committee once again, and thank you to all for coming to the most exciting breakout session. I want to thank my co-authors that you see listed here for their help with this. These are our disclosures. And numerous studies in the past have showed the efficacy of onabotulinum toxin A in the treatment of urinary incontinence with regards to decreased urinary incontinence episodes as well as improvements of quality of life. What hasn't been characterized very well is that time to onset, and that was the purpose of this study, was to try and quantify the time to onset when Botox was injected. The setup of the study was similar studies with Botox. It was a randomized multicenter placebo-controlled double-blinded phase four. This was a phase four trial. And the screening criteria you can see here, some of them at least the key ones, greater than or equal to three urgency urinary incontinence episodes over a three-day period as kept on a diary, greater than or equal to eight mcturitions per day averaged over the three-day diary, and the patient having been inadequately managed by an anticholinergic. If they met these criteria, they were then randomized one-to-one to either receive the onabotulinum toxin A or placebo. Twenty injection sites were used for the injections that were done. Outcome measures were recorded first at baseline, then at one, two, six, and 12 weeks. The primary outcome was the decrease in baseline of urinary incontinence episodes as kept by the diary. Also proportions of patients achieving 100% and also 50% reductions in their urinary incontinence. You can see the quality of life measures that were used here, and adverse events were also recorded. The primary outcome was kept from a three-day diary that was kept by the patient beginning in that first week after treatment. The results, as you would expect, the randomization process worked, and there's no difference between the two groups of note, is that the urinary incontinence episodes per day, you can see for the Botox group is 5.4 and for placebo 6, so these were patients who were very symptomatic. And for the primary outcome, which is reduction in incontinence episodes per day, you can see that from the first measurement taken during the first week, there was a statistically significant decrease that began, so you can feel confident telling most of your patients they'll see something within that first week. That was continued through the 12-week study. As you can see here in the purple, the placebo is shown in the gold. The secondary outcome looked at the 100% reduction. You can see nearly a quarter percent of patients were completely dry within that first week. That slightly increased up to 30% by the end of the study period, and greater than a 50% reduction was achieved in nearly 60% of patients in the first week following treatment. That was also sustained throughout the study period. Also recorded from the bladder diary were micturition episodes per day, nocturia, and urge urinary incontinence episodes broken out, and the red rectangles show where statistically significant differences were seen, particularly in the urge urinary incontinence episodes per day, once again within that first week. This is proportion of patients who were using known incontinence pads, and I don't think this is too surprising. About a third by the end of the first week. It's kind of hard to change behavior patterns to get people to feel comfortable, but by the end, nearly 50% were not using any pads at all. Quality of life also showed statistically significant improvements within that first week as far as the IQAW. The ICIQ did not the first week, but did the second week, and you can see the trend starting. So once again, early and sustained relief from symptoms. And the King's Health questionnaire on the domains of role and social limitations also shows statistically significant differences beginning that first week. Safety and tolerability, there are very few unexpected side effects. You can see UTI as well as urinary retention at 7.1. This is in line with other studies. So in summary, in this population of patients with OAB, improvements were seen as early as one week. They were sustained throughout the 12-week period with reduction in urinary incontinence as well as improvements in quality of life, and there were really no new safety signals received. Thank you, and I'll take questions at the question time. Thanks so much. I appreciate it. I appreciate the scientific committee allowing me to present these data on behalf of my co-authors, and I want to thank my setup man, Doug, for presenting a lot of the preliminary data. So maybe I can cruise through this a little bit more quickly. Here are disclosures, and I want to thank my co-authors, and so as Doug told you, these are data looking at a randomized placebo-controlled trial using onobotulinum toxin A, and as he showed you, it demonstrated significant improvement in quality of life and significant reduction in urinary incontinence episodes as well as urgency and frequency, but we're always concerned about adverse events with using any kind of toxin within the bladder, and specifically, I wanted to look at the risk of clean intermittent catheterization based on our standardized criteria within the Phase III studies for doing clean intermittent catheterization, and we're looking specifically, apropos of this meeting, at the female cohort, and obviously, as in all these trials, females make up the vast majority of the trial population. Doug showed you the study design. I'll just quickly reiterate it here, because we're adding in the cohort in the second treatment cycle of 12 weeks where individuals who were initially randomized to placebo crossed over to active treatment with 100 units of onobotulinum toxin, and Doug went through these assessments, as you see listed here, and so we wanted to see how people did not only in their first cycle, but how they did with re-treatment in the second cycle, and I want to highlight to you, it's very, very interesting to look at specifically those who crossed over from placebo to active treatment, because for some interesting reason, they actually did better. They did better with decreased retention and need for self-catheterization, and they did slightly better when it comes to outcomes, and here's the cohort that you saw at baseline. When we look, I'll call your attention, Doug pointed out some other things, but in the King's subscales, you see that this population was moderately to severely affected when it comes to the King's health questionnaire. So when we look at incidents of clean intermittent catheterization in female patients with overactive bladder in the first 12-week cycle of the trial, and I just want to reiterate, or, well, I didn't actually say it, I just want to explain that individuals within the trial who had post-void residuals of 200 to 350 milliliters of urine after voiding, it was at the discretion of the investigators whether those subjects should do clean intermittent catheterization. Anyone who was above 350 milliliters was to do clean intermittent catheterization per protocol. So when we look at the female cohort, 5.2% of all the women who received active treatment with onabotulinumtoxin A were self-catheterizing at some point, and that period of self-catheterization, the median period of self-cath, was about eight weeks. In the second treatment cycle, those who crossed over from placebo had a CIC rate of only 2.9%. Now the cohorts, we did lose some, as you can see here, so of the 633 subjects, there were only 510, but placebo subjects had no reason to discontinue and not go into the open-label phase of the trial because of an adverse event, they received placebo. In the cohort that had received Botox before, you can see there's some significant attrition. Our denominator's down to 413, so it may be an enriched population when it comes to avoiding retention, but their rate of retention and need for self-catheterization was 3.9%. But the 2.9% number is very interesting. When we look at, let's go a little bit further, when we look at reduction in urinary incontinence episodes, you can see robust changes in both the first and second treatment cycle. And again, those who were initially in the placebo cohort and crossed over, they did slightly better, numerically better, probably not statistically significantly better. When we look at reductions and the sub-analysis for those who were completely dry, 100% reduction in incontinence episodes on a three-day diary versus 50%, again, as Doug pointed out, we're looking at 29% of the patients in the first cycle, but for the placebo patients who crossed over in treatment cycle number two, they had a 32% dry rate. And the 50% reduction level, 64 and 71% in the second cycle. So no tachyphylaxis, donor botulinum toxin, which is equivalent to what we've seen in other trials looking at three-and-a-half-year outcomes. In the King's health questionnaire subscales, we see dramatic improvement both in treatment cycle one and treatment cycle two, with the vast majority of people having a greater than 10-point reduction, which is the minimally important difference for this measure. When we look at those receiving a positive response on the treatment benefit scale, again, the same sort of thing. Nearly 60% of people receiving a significant improvement in their treatment benefit scale, saying they're better or much, much better, and the same was true in treatment cycle two, and the same was true for individuals who crossed over. AEs were pointed out to you in the first cycle by Doug, but in the second cycle, basically equivalent. UTIs affecting around one in five individuals with active treatment in both cycles, and you see urinary retention, as we mentioned, being lower in the second treatment cycle. So in this large cohort, where we looked at patients in their first and second treatment cycles, so those receiving placebo could cross over, there was certainly no increased risk of clean urinary catheterization in subsequent cycles. Actually there was a numeric decrease, and there was no tachyphylaxis that developed in terms of outcomes, as we have probably all gained experience with. Thanks so much for your attention. The first presentation will be Dr. Sand again, and the title of this presentation is called The ECOIN Implantable Tibial Nerve Stimulation Device for Overactive Bladder Syndrome Improves Quality of Life. Thanks so much. That's great. Well, I want to thank my co-investigators, and again thank the AUGS Scientific Committee for allowing us to present these novel data. And here are relevant conflicts of interest. So ECOIN. ECOIN is roughly the size of a nickel, and it can stimulate at 20 pulses per second with an amplitude range from half a volt, I'm sorry, half a milliamp to 15 milliamps. So in this feasibility trial, 46 women were enrolled in the U.S. and in New Zealand. They were stimulated for 30-minute stimulation sessions twice a week for 12 weeks. Brain diary assessments were carried out, as you see, at baseline for 8 and 12 weeks, and safety was controlled by self-reports of adverse events. And you see statistical methods here. What's ECOIN? Well, we take this device, and we make an incision just a couple centimeters above the implant site and drop the device down just above the peripheral tibial nerve, as you see here, just cephalad and posterior to the medial malleolus. And it's surgically implanted, allowed to heal for 4 weeks, and then the device is activated. And at the end of 12 weeks, compared to baseline, you can see a significant improvement in urinary frequency. We also saw a significant reduction in urgency urinary incontinence episodes from 5.24 to just under 2 episodes at 12 weeks per day, excuse me. Twenty-three percent of subjects within the trial were completely dry, and 70 percent of subjects had a reduction in their incontinence episodes by 70 percent. We look at results on the iQOL. You see the MID here is 10, and 72 percent of the subjects had an improvement in their iQOL scores greater than 10 or greater than the MID. When we looked at the PGII, 31 of the 43 subjects, or 72 percent, said they were feeling better. Thirty percent said, I'm sorry, said they were better after 12 weeks. Thirty percent qualified themselves as better. Seven percent as much better. And 35 percent as very much better on this scale. Complications. There was a superficial cellulitis in one woman, not at the incision site, remarkably enough, but all subjects wore an ankle wrap after the performance of the procedure for four weeks. And the actual ankle wrap, because of friction, created the superficial cellulitis. And one woman developed a limp who had hip bursitis prior to enrollment. This was not felt to be related directly to the device or the surgical procedure. So early data certainly would support the safety and efficacy of ECOIN for the treatment of overactive bladder syndrome with improved quality of life and significant reductions in urgency, frequency, and urgency urinary incontinence episodes. It's a relatively easy procedure to perform in the office. And as you saw, 23 percent of subjects, at least in this feasibility trial, were completely dry on a three-day diary after 12 weeks. Thank you so much. The presenting title is Continuing Percutaneous Tibial Nerve Stimulation After 12 Weekly Sessions. A Randomized Controlled Trial. Thank you for allowing us to present our research. We have no disclosures. Percutaneous tibial nerve stimulation is well studied, and we know works to inhibit contractions of the detrusor muscle, reducing urinary frequency and urgency. It provides an option for patients who are refractory to anticholinergic therapy and is minimally invasive. It's associated with cost for the patients, however, and in our setting at Harbor UCLA, that includes time away from families and work, transportation costs, and clinic wait times. So our objective is to compare treatments between the standard monthly maintenance therapy, which we'll call Q-Month, and sessions scheduled per patient request, which we'll call PRN. And we use validated measures for quality of life, satisfaction, and symptom bother. We hypothesized that there would be no difference between the Q-Month and the PRN groups for these measures. This is a single center, randomized controlled trial with ethical approval from our IRB, as well as patient written consent. It was done at our clinic at Harbor UCLA between November 2016 to December 2017. An a priori power analysis for equivalence test of means determines the sample size to be 78 patients in each group for 80% power. We were unable to, there were limitations for gathering this many patients in our clinic setting, so the current study is under power to determine non-inferiority, but we will focus on trends and effect size calculations. So participants had completed 12 weeks of PTNS therapy and desired to continue. They were females with overactive bladder and either spoke English or Spanish as primary language. The two interventions were, again, Q-Month, where the patient is scheduled for a monthly visit after finishing their 12 sessions, and then the PRN was given, group was given our clinic nurse's direct line to make an appointment when their symptoms of OAB returned. That could be anywhere between 2 and 12 weeks after the 12 sessions of PTNS. Over a 14-month period, 47 patients were assessed for eligibility, 45 met criteria, and 36 patients were recruited into the study. We used the outcome measures, again, validated questionnaires for quality of life, satisfaction, symptom bother. We also did a point-of-care urinalysis to rule out infection, and we also gave the patients open-ended questions to find out what their experience was like with PTNS. Both groups were similar in demographic characteristics with an average age of 58, primarily Hispanic, Spanish-speaking women. The average number of clinic visits was not significantly different for the Q-Month and the PRN group. Although no patients formally switched groups or maintenance schedules, a number of patients in the Q-Month routinely missed or rescheduled their appointments. After six months of maintenance therapy, 42% in the Q-Monthly group and 53% in the PRN group chose to continue PTNS. Analysis for quality of life scores using the OABQ short form HQRL indicate that while scores in the PRN group significantly decreased in the three-month period, the increase in quality of life was not significant for the Q-Monthly group. So the results suggest that the change in quality of life is different between the two groups, that the PRN group has a higher quality. Changes in the visual analog scale and the benefit satisfaction and willingness to continue scores were analyzed to assess patient satisfaction. Treatment satisfaction was comparable between the groups. Changes in symptomatology were assessed using symptom severity section for the OABQ-SF and by the OAB symptom severity scores. Change in the OAB-SS scores moderately varied across groups while significantly increasing in the PRN group. Given the mixed findings and moderate effect sizes, additional analysis is needed with a larger sample size. Our findings suggest a trend towards comparable treatment satisfaction and a higher quality of life for the PRN group compared to the Q-Monthly group. Additional analysis with larger sample size is warranted for a population where the prevalence of urinary incontinence is high and access to care is lower than other groups, it's imperative that we have long-term effective treatment for OAB. We'll be Dr. Enger presenting on Comparative Effectiveness of One-Versus-Two-Stage Sacral Neuromodulation Device Placement. Dr. Whitcomb, Dr. Ritger, members and guests, thank you for the opportunity to present what looks like the third abstract trying to make patient experience easier with overactive bladder. Sacral nerve stimulation is a minimally invasive third-line therapy for overactive bladder and other LUTs refractory to medical therapy. The best outcomes to date have been shown to be a two-stage procedure in which the patient undergoes lead placement in the operating room followed by battery placement one week later if the patient is at least 50% improved. Despite high success rates, sacral neuromodulation remains costly compared to other third-line therapies. In a single-stage procedure, the test phase is eliminated and both the battery and the lead are placed together at the same time. This avoids a second intervention in those who respond, however, it does mean that a small percentage of non-responders will have a battery in their behind. Our hypothesis was that in patients with higher likelihood of successful symptom improvement with sacral neuromodulation, performance of a one-stage procedure would be more cost-effective than a two-stage procedure. We created a Markov chain model to compare the cost of a traditional two-stage procedure to a single-stage procedure. The cost of SNS placement was then defined using CPT-4 procedure codes, which were mapped to ambulatory payment classifications for facility, provider, anesthesia, and device costs. Medicare National Average payments were determined using a 2017 conversion factor. Here are the codes that we used, which include the code for incision or implantation of the lead, which is $6,000. Fluoroscopy and analysis of the implanted pulse at generator system both cost about $100. The battery placement, which is $18,000. And then removal procedures, which are $2,800. Here you see in two stages, the initial procedure is approximately $6,000. If successful, the battery is $18,000 or the device is removed at $2,800. Below is the combined single-stage procedure, which involves the first stage, which is $18,000, including the battery and the lead, which if successful, there's no further procedure, or if unsuccessful, the removal procedure is $5,700. But note, some patients don't need to have their battery removed if it's not bothering them. Here you see on the X-axis is the rate of successful conversion and on the Y-axis is the cost. For a two-stage procedure in red, as the successful conversion rate goes up, the costs rise. In a combined one-stage procedure, as the rate of successful conversion goes up, the costs decrease. The cost difference between one versus two-stage placement varied based on the rate of successful conversion. If a conversion rate from testing phase to permanent placement is greater than 71%, then utilization of a one-stage or combined approach proved to be cost-effective compared to a two-stage approach. Here we need to take into account several factors which may predict success. Patient factors, so if you have a young woman with OAB wet who leaks, she's probably going to have the highest likelihood of doing well. Operative factors such as time leads, curve leads, checking for motor, making sure you have a good response in all four portions of the lead, etc. may all have an impact on outcomes. As well as provider factors. Someone who does many of these may have a better outcome than someone who does not do these often. Our limitations are that we relied on reimbursement costs but may not have actually reflected charges and did not include patient-related expenses and loss of work. We did not factor in the benefits of a one-stage such as avoiding two procedures and possibly, particularly in obese patients, reducing that time, that one-week time with a lead that's in a wire that's basically a risk for infection. We also assume that complications were the same between two groups. In conclusion, the benefits to a one-stage SNS included reduced anesthesia, reduced infection rate, reduced patient travel and time off from work. The risk of a one-stage is a potential need to remove an expensive generator or leave it behind that have incurred cost of $18,000. From a cost perspective, if the success rate is higher than 71%, a one-stage procedure may very well be cost effective. Thank you. Thank you to all of our presenters. We'd like to open the floor for questions. We have five minutes. Dr. Anga, very interesting and important presentation. It rests on your ability to predict who will succeed. So how confident are you in your prognostication? Do you have an algorithm that helps you to do that? That's a good question. Over time, I've had not-so-good success with idiopathic retention. And actually, the data in Medicare really supports that women do like twice as well as men. So I think if this is something that we're going to see try, possibly that younger woman with OAB wet who's going to have the best outcomes. My first one I did, I'm going to try a one-stage. And it was an older woman and it didn't do very well. So, you know, there is that risk. Catherine Hill from Portland, Oregon. A question for the PTNS presentation. In the PRN group, when they called and came back, did you do just one maintenance treatment at that time and then wait for them to call again? Or did they have a couple in a row and then wait to call? Sure. Thank you for the question. So the PRN group, when they called with symptoms, they were given one session. So we did not redo the 12 sessions of therapy. They just had that one session and then they would call back again to have another session. And do you have data on how quickly they would call back after? Yes. So it was typically four weeks. Even after the first retreatment, after each retreatment, they would call? After each retreatment, they would call back. The average was about four weeks, which was the same as our Q monthly group. But the quality of life was higher, maybe suggesting that patients feel if they have control of their care, they have better quality of life. Thank you. I'm going to just sneak in for a question and follow-up. Was there a standardized amount of time after the call that patients had to be worked in for the treatment? They were given, instead of the central number, they were given a direct line to our nurse who knew that we were doing the study. So they would get in one to two days, depending on the patient's schedule. Mimi Lucas, San Diego. This is for Dr. Zigman. I noticed that your sample size is significantly lower than what your power calculation was. Did you stop recruitment because of tough to get people enrolled? Thank you for the question. We definitely wanted to have a larger sample size in both of our groups. Two factors. We were trying to start at a second site. And for logistical reasons, that did not happen. So we were trying to have this multi-center study. And the other reason, there was a concurrent fellow study going on at the same time, also looking at a different aspect of PTNS, where we were initiating PGII at the sixth visit. So when I was in the planning phases, we assumed, based on our numbers up until that point, that we would have more patients get to the 12-week mark. Once we started asking patients more frequently using PGII, potentially switching to a different method throughout, we had less people getting to the 12-week mark, so that decreased our enrollment. And so you've stopped the study? We've stopped the study because I graduated, but the torch has been passed. Well, I just want you to be careful that if you report on the subsequent people, you have to calculate that into your analysis plan. If it's a planned interval analysis, you can't submit that again. Thank you. Thank you guys so much for your presentation. Just a question for Dr. Stand. Overactive bladder patients clearly come in a range of ages and activity levels. Can you comment a little bit on any of the physical activity limitations due to the location of the implant and whether there was an issue with migration? Yes. Thus far, out 18 months, migration hasn't been an issue. But subjects are limited in their activity during the healing phase, four weeks, and so they really can't be very active. Beyond that, individuals are allowed, they're counseled to just do what's comfortable, basically. And they run. Right. So people, there have been people biking and running. Yes. Hi, Kate Bradley from Iowa. I have a question for Dr. Enger. Interesting study, and I understand that looking at the cost savings is kind of done overall, but it occurs to me that all the benefits of the one stage procedure are going to people who are successful, and all of the downside in terms of having to have a second surgery, losing time at work, increased complications, et cetera, are for people who are failures, and it seems like that would be a really, they would be very unsatisfied. I don't know if you have any comments about that, or how do you counsel patients about the idea? I think that's true. I mean, in many patients whose devices stop working, I think we remove the batteries in only a fraction. So I have one patient who's an older woman. She's not bothered, so you don't necessarily need to take it out. But I think that's where the clinical studies are going to come into play, for sure. That's a good question. Good afternoon. My name is Jordan Enger, and I'm actually a second year medical student, so I'm not quite a doctor yet, but almost there. And I'd like to thank the committee for allowing me to present our study today. And I have no relevant financial relationships to disclose. So health literacy. Our understanding of health literacy and the role that it plays in health care is becoming increasingly important as we realize that a patient's health literacy plays a large part in our ability to navigate the increasingly complex health care system we have today. So according to the World Health Organization, a third of the U.S. population has basic or below basic health literacy skills, and only 12 percent are proficient. And previous studies have shown that lower health literacy is associated with poor health care outcomes and poor compliance to health care plans. So how does this affect urogynecology? In our field, we often use validated pelvic floor questionnaires in clinical care and research to characterize patient symptoms and track changes in those symptoms over time. And a patient's health literacy plays a large role in her ability to understand those forms and accurately fill them out. So two commonly used forms are the PFDI-20 and PFIQ-7, which we used in our study. So the average American adult, according to the NIH, reads at an eighth grade reading level, and they recommend that patient written materials not exceed this level. However, a 2013 study found that half of commonly used pelvic floor questionnaires did not actually meet this criteria. So in addition to reading level, things like formatting, organization, and plain use of plain language also affect the effectiveness of our print materials. So the objective of our study was to evaluate the performance of PFDI-20 and PFIQ-7 in a low health literacy population. And we did this first with a formal readability assessment. We used four readability tools, three that were specifically for narrative text and one that was designed for questionnaires. And each tool assigned a U.S. grade level to each form. We also had two health literacy experts that did a PMAT analysis on each form to evaluate the understandability and actionability. They also did an ELFQ analysis to evaluate the formatting, organization, and overall content. And then we also did a focus group. So our focus group, we selected participants that were females with low health literacy and in age ranges that reflected our urogyne population. And the participants were instructed to validate the forms or evaluate the forms using a validating coding method, and they participated in a facilitator-led discussion and then rated each form on a scale of 1 to 10. So these were the results of our readability assessment. The important thing to note here is that the PFDI-20 did fall below that recommended 8th grade reading level, but the PFIQ-7 did not. For our PMAT consensus, they found that both forms had an unclear purpose and a confusing question format. The PFDI-20 specifically used a lot of complex medical jargon, and the PFIQ-7 used terms like somewhat and moderately, which were difficult to distinguish between. ELFQ analysis similarly found that both forms lacked a clearly stated purpose and also lacked a logical progression or grouping of questions. For our focus group, we ended up having nine English-speaking African-American females between the ages of 31 and 81. Seven out of nine had attended some college, and eight out of nine were screened to have low health literacy. They rated the PFDI-20 as a 5.4 out of 10. They felt that the instructions were clear, but really struggled with some of those medical jargon terms, and they disliked the format and length of the form. For the PFIQ-7, they rated it an 8 out of 10, felt that they understood most of the questions, and they really liked the table formatting. Overall, we found that there were three main areas in which the forms were lacking, and that was purpose, language, layout, and administration. We comprised this table of recommendations to propose ways to improve the utilization of these forms without actually going in and making changes. For example, for the PFIQ-7, it may be helpful to emphasize to your patients that they're evaluating how much the symptoms affect their ability to do an activity, not the frequency at which they are able to do the activity. Similarly, for PFDI-20, it may be helpful to encourage the patients that they are evaluating how much a symptom bothers them, and not how frequently that symptom occurs. So overall, we found that it would be helpful to have someone available to answer questions, make clarifications, define confusing terms, and we realize that that's not feasible in all settings, but especially when these forms are being used for research purposes or with patients that are known to have low health literacy, having someone available to help administer the documents may improve the quality of the data collected. So in conclusion, we'd just like to acknowledge that there are barriers that our patients face when trying to fill out forms such as the PFDI-20 and PFIQ-7, especially when these women have low health literacy, and having someone available in clinic to help with completion of these forms may improve the quality of the data that's collected from them. So thank you very much. Thank you to the committee for allowing me the opportunity to present this work. Listed here is our funding. We have no relevant disclosures. So more than 60% of women over age 65 have urinary or fecal incontinence, yet most do not seek care. Behavioral treatment strategies to improve incontinence exist, including pelvic floor muscle exercises, fluid modification, and bladder training. Continence promotion interventions deliver this information and build skills to make these behavior changes. Studies have shown various formats of continence promotion are effective, formats including a single class, a series of classes, or electronic and online programs, such as a video or an app. The aim of this study was to understand the values that inform a woman's behavior, and to understand the decision and preference for these formats. For this study, we partnered with a population-based health survey called the Survey of the Health of Wisconsin, known as SHO. SHO completes in-person interviews with a randomly selected sample of households that are representative to the state of Wisconsin. Participants are also asked to complete self-administered computer questionnaires where we included questions about their incontinence status and their likelihood of participating in various continence promotion formats. Women with incontinence in the 2016 Survey of the Health of Wisconsin ranked these three continence promotion formats, a single lecture, a three-session workshop, or an online program. A sub-sample of women who preferred each format were invited to participate in this qualitative study. We completed 30-minute audio-recorded phone interviews that were transcribed verbatim. The amount of content analysis characterized the perceived advantages and disadvantages to each of these formats. We identified 243 women with incontinence in the 2016 Survey of the Health of Wisconsin. In this table, you'll see a breakdown of the preferences of these women and the women included in the qualitative study. The majority of women preferred an online program. Next, they preferred an in-person lecture, and very few women preferred a three-session workshop series. We invited 41 women to participate in the qualitative study, and 23 went on to complete interviews. The mean age of the qualitative study was 67, with a range of 51 to 93. Proponents of an online continence promotion intervention noted that convenience and privacy and opportunities for self-directed learning were the main benefits. They cited several drawbacks, including lack of accountability, lack of community, and difficulties with technology. Those who preferred the single lecture noted the convenience and anonymity, and they liked being guided through a lecture in a traditional classroom format. They noted a few drawbacks, including lack of social connection and lack of privacy, because they still might run into someone they know. Those who preferred the workshop series noted the lack of accessibility, the benefits of accountability, community, and experiential learning. But several women did not like this option because of the lack of convenience, lack of privacy, and lack of comfort talking about sensitive topics in a small group. In conclusion, a digital format is preferred by most women with incontinence in this study. Values informing women's preferences are convenience, privacy, learning style, accountability, and community. These values should be considered in future intervention development, adaptation, dissemination, and implementation efforts in order to maximize the reach of these continence promotion interventions. Thank you. Good morning. I'll be presenting our work on stigma this morning. We have no disclosures. The primary aim of this study is to quantify the level of stigma in women presenting for urogynecologic care using a validated scale, which to our knowledge is the first study of this kind. And our secondary aim was to test our hypothesis that stigma related to pelvic floor disorders would result in a care-seeking delay. To do this, we took a sample of 523 women who were all presenting for new patient visits at our Interdisciplinary Pelvic Floor Disorder Clinic from May 2017 through February 2018. All of these women were given two anonymous surveys to complete before their visit. They're both written and validated surveys and included the stigma scale for chronic illnesses eight-item version for the SSDI-8 and the Pelvic Floor Bother Questionnaire or PFBQ. We also included an analysis of the stigma scale for chronic neurological disorders. Here you can see the stigma scale that we used that you're probably not familiar with. It asks a series of eight questions rated on a scale from never to always that represent different aspects of stigma. This scale has been validated in a population of patients with chronic neurologic disorders. The scores in total can range from 8 to 40. And just as a reminder, the stigma scores range from about 12 to 15. Here you can see the results in a box plot of our pelvic floor disorder patients. On the x-axis you see the presenting complaint. And on the y-axis you see the stigma score. We found that our patients presenting with pelvic organ prolapse overall had the lowest stigma scores. And those scores gradually increased when patients were presenting with urine leakage, higher with constipation, and the highest scores in those presenting with accidental bowel leakage. The constipation and accidental bowel leakage scores were in those 14 to 15 range. How does stigma result in a care-seeking delay? We asked patients on our survey, how long did you wait before seeking care? And defined a care-seeking delay as waiting greater than or equal to one year. Here we found that our patients with a higher stigma score actually did not wait as long to seek care. And this was significant. Interestingly, some factors that were not associated with the degree of stigma were having friends or family with similar disorders or the education level. And you can see we do have a higher than average education level in our population. We then used a logistic regression model to find factors associated with a care-seeking delay. And found that presenting with urine leakage increased the odds of a care-seeking delay. And having a higher stigma score significantly decreased the odds of a care-seeking delay in contrast to our hypothesis. Now what's the correlation between stigma and degree of symptom bother? To answer this question, we compared the stigma scores and PFBQ scores for the same patient. And found a moderately positive correlation between the two that was significant. So in conclusion, we found that our patients with accidental bowel leakage have the highest level of stigma in our population. And those presenting with pelvic organ prolapse have the lowest levels of stigma. Patients who feel higher stigma levels seek care earlier. And the degree of stigma and symptom bother increase together for our patients. Thank you. We will now take questions. Sherry Palm, Association for Pelvic Organ Prolapse Support. And I don't quite have the question formatted in my head yet, so bear with me here. I'm really surprised to see the lower level of stigma with the POP patients. So I'm curious, are these, the women that you included in this study, are they, I mean, they're just recently diagnosed? How did you determine, I mean, what, how were they placed in? I mean, what was the backdrop? Okay. So the POP patients were diagnosed with pelvic organ prolapse by a primary care provider, a general OBGYN, and then referred to us. And our hypothesis about the lower level of stigma in those patients is that it's a less visible disorder in some way than having urinary or bowel leakage because a lot of people with incontinence might feel that people know because there's a smell or something like that. And then the prolapse is a little more invisible was our hypothesis. I'm really, I'm frankly shocked by that because we hear the most stigma for our following is tied to that vaginal tissue bulge. And we hear that all day, every day. Very interesting. I'm curious, interesting though. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda. Rhonda.

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