Thank you very much. Thanks to the scientific committee for allowing us to present these data. Just first, my disclosures. Sorry. So, we know that overactive bladder syndrome is not fully understood. We just heard a great presentation across the hall to amplify that and it probably comes from multiple etiologies and there are multiple theories about the origin and the neurogenic theory of OAB certainly suggests that there's some upregulation of afferent nerves, most specifically C-fibers in the trigone that are normally quiescent and that these fibers in the trigone and bladder base might be responsible for conveying primarily the sensation of urgency. Selective bladder denervation is a radiofrequency ablation technique of the subtrigonal tissue that specifically is aimed at disrupting these afferent nerves without affecting the surrounding tissue adversely so it doesn't affect the urethelium or the underlying vaginal tissues. The SBD procedure appears to have durable effects as we'll show you with data going out to 18 months in this abstract and it's certainly a unique intervention that's confined to the trigone and therefore it's an interesting model to allow us to understand the relationships not only of urgency and non-urgency voids that we'll look at in a moment which is somewhat confounding, but also to see is there a specific neurogenic etiology potentially for OAB in that if we destroy C-fibers and these other sensory fibers specifically concentrated in the trigone, will that influence the symptoms and syndrome of OAB in these individuals. So to study the effects of SBD procedure for 18 months in women suffering from refractory OAB is certainly the primary objective of this trial which was a feasibility study and also we wanted to examine the differential effects of SBD on urgency and non-urgency voids as well as symptom bother. And the trial was a multi-center, multi-national feasibility trial as I alluded to earlier of 35 women with refractory overactive bladder syndrome. You see the inclusion and exclusion criteria here. Individuals are screened with ultrasound and cystoscopy at least for the latter part of the trial. The intervention included one radiofrequency ablation procedure for 60 minutes that was temperature controlled by a specific algorithm and applied as we'll see in a moment at multiple sites along the trigone. Follow-up was done at 1, 3, 6, 12, and 18 months and I'm reporting 18-month data for you here on 24 of these individuals. Assessments were done with a 3-day voiding diary, treatment benefit scale, and quality of life measures including the King's Health Questionnaire and the OABQ, short form. So here graphically just showing you the steps to the procedure at each treatment site. We isolate the tissue treatment site with endoscopic guidance. We deploy two electrodes into the tissue at a specific depth and then we're ablating for 60 seconds with numerous controls, thermocoupler controls, to avoid any uncontrolled destruction of tissue. And then this is applied at 3-6 different stripes along the trigone to avoid the ureteral orifices and bladder neck. And we can see the primary outcomes here looking at urgency and urgency urinary incontinence in these 24 individuals. You see a dramatic decrease in both urgency and urgency urinary incontinence at the one-week evaluation and good persistence for the majority of these individuals out to 18 months. When we look at all variables here, it's a very busy slide, but just to show you by the asterisks what significance we had, not just in the diary data but also in the King's Health Questionnaire and the OABQ, you can see significant changes from baseline to 18 months. And to focus in on the subject of interest here for this evaluation, looking at urgency urinary incontinence for episodes, we can see a dramatic decrease between baseline and 18 months, so good durability there as you saw in the graph. A marked decrease in urgency episodes per day. But when it came to voids, urinary frequency, there isn't, there's a little decrease in voids. And when we looked at this carefully and sub-analyzed it, we were seeing a marked reduction in urgency voids. Subjects in their diaries said that I felt a strong urge to need to urinate before they went. But actually the other voids, the non-urgency induced voids, actually increased from baseline to 18 months, which is sort of curious and may have something to do, we would hypothesize, with the fact of what happens when we knock out C-fibers in the trigon. Adverse events, unfortunately the very first patient had an undiagnosed congenital ureteral seal that was ablated. And that led to obstruction of that ureter orifice, pyelonephritis, which resolved with antibiotics. She needed a stent, but she's very happy to this point. And at 24 months, she's symptom-free. You see the other side effects here. So in conclusion, SBD appears to be effective for refractory OAB with durability out to 18 months. Certainly we need longer term follow-up. And the data certainly support that the trigone may be the pathologic nidus of refractory OAB and may provide further evidence for a potential neurogenic etiology of refractory OAB. Thank you so much. We would like to thank Akshay Yuga for this opportunity to present our work and thank you all for staying for this last session. These are our disclosures. As we know, sacral neuromodulation can be used for a variety of pelvic floor disorders, both bladder and bowel related. It's typically preceded by one of two test phases, either the first stage lead placement or the percutaneous nerve evaluation. PNE is usually a temporary monopolar lead without retention mechanism, which is easy to deploy and remove, thus facilitating either an office or outpatient placement or removal. The success rates of PNEs are typically between 40 to 62 percent. And at this time, there's no evidence supporting the routine use of fluoroscopy at the time of PNE. The objective of our study was to evaluate whether PNE without fluoroscopy is inferior to fluoroscopy use in women undergoing trials of sacral neuromodulation. We hypothesized that sacral neuromodulation implantation rates within three months of PNE would be non-inferior for PNE without fluoroscopy as compared to fluoroscopy use. This was a randomized non-inferiority trial. Women planning a PNE for any indication were included. They were recruited from an academic clinic between August 2015 and December 2018. Patients were excluded if they were not candidates for a declined either sacral neuromodulation or PNE and if they were unable to consent. We started out with a 20-patient non-randomized lead-in phase to perfect our protocol. We assigned 10 patients to the no fluoroscopy group, followed by 10 to the fluoroscopy group. Subsequently, we randomized patients one is to one to fluoroscopy or no fluoroscopy using SNOS. We required 33 participants in each group for a total of 66 for 80% power with a non-inferiority margin set at 30%. Participants underwent a five to seven day trial and if they had greater than 50% improvement they were offered permanent placement. We recruited a total of 94 patients which included our 20 patient lead-in and our 74 patient randomized sample. We had 46 in the fluoroscopy group and 48 in the no fluoroscopy. There were no differences in results on analysis with and without the lead-in patient. We had no significant differences in most baseline characteristics. The most common indication for PNE placement was urgency incontinence and there were more mean points per day at baseline in the no fluoroscopy group. So here are our results. On this graph you can see where we marked out our non-inferiority threshold. If we had found that PNE without fluoroscopy is inferior to PNE with fluoroscopy, we would have expected our confidence intervals to lie on the right of that non-inferiority threshold. If our results had been inconclusive, we would expect that confidence interval to cross the non-inferiority threshold. If we had found that PNE without fluoroscopy is non-inferiority we would expect the confidence intervals to lie on the left of that non-inferiority threshold. And if we had found that PNE without fluoroscopy was superior, we would have expected those confidence intervals to lie on the left of the zero difference line. Our success rates in the no fluoroscopy group were 54.2% and in the fluoroscopy group were 56.5% giving us a difference of negative 2.3% meeting our definition of non-inferiority. The sense of this study was that it was an adequately powered randomized trial which used objective outcome measure to try and minimize bias. The limitations were that there was no set fluoroscopy protocol. Providers could use fluoroscopy at their discretion to facilitate PNE placement. This was an unblinded study so neither the participants nor the providers were blinded by their randomization. And it was performed at a subspecialty FBMRS clinic with predominantly Caucasian patients thus limiting its generalizability. We concluded that PNE without fluoroscopy is non-inferior to fluoroscopy in this trial. Our data demonstrates that given a shorter procedure time and similar rates of adverse events, PNE can be offered without fluoroscopy to patients undergoing this procedure. Thank you for your time. We would like to thank the scientific committee for allowing us to present our work. We have no disclosures. The elimination of urine is achieved by detricer contraction and simultaneous urethral relaxation. As urine flows to the urethra, this activates pudendal sensory nerve fibers which send excitatory signals to the bladder, augmenting bladder contractions and leading to efficient voiding. This is known as the augmenting reflex. It's been shown in rats that disruption to this urethral sensory feedback either by transfection of the sensory branch of the pudendal nerve or by administration of intraurethral anesthesia reduces voiding efficiency. Disruption of this sensory feedback system may also contribute to incomplete voiding and urinary retention in humans. To see if this mechanism applies to humans, a pilot study was performed of healthy female volunteers which demonstrated that intraurethral 2% lidocaine did not decrease voiding efficiency. However, those who received lidocaine and whose sensory input from the urethra was therefore blocked demonstrated interrupted urine flow patterns and were not relaxed during voiding. This made us think the augmenting reflex is involved in normal human micturition and warrants further investigation. By better understanding the mechanisms that enable efficient voiding in healthy humans, we can determine if the augmenting reflex is a potential target for treatment of incomplete voiding. Our primary objective was to assess voiding efficiency in healthy females randomized to 4% intraurethral lidocaine or placebo. Secondary aims included assessing other urodynamic factors and to determine whether 4% intraurethral lidocaine changed pain during catheterization. We performed a randomized double-blind placebo-controlled trial of healthy adult female volunteers recruited at Duke University between October and December of 2018. Multiple inclusion and exclusion criteria were used in order to have the most healthy female participants possible. Of note, participants were excluded if they reported baseline lower urinary tract symptoms, baseline pain, or if they demonstrated an abnormal baseline uroflow. Screening for eligibility consisted of a review of demographics, health history, medications, and completion of a lower urinary tract symptoms questionnaire. Participants then completed a baseline uroflow to ensure a normal voiding pattern and a baseline visual analog scale to ensure no baseline pain was present. If they met criteria at this point, participants were randomized to receive placebo or lidocaine. Participants received two doses of 5 milliliters of the intraurethral agent they were randomized to, which was separated by 15 minutes. They then underwent a second uroflow under the randomized condition and completed the remainder of urodynamic study. Thirty participants were recruited and assessed for eligibility. Ultimately, 18 participants were randomized and included in the analysis with 10 receiving placebo and 8 receiving lidocaine. For our demographics, the mean age was 31 years old and mean BMI was 25 kilograms per meter squared. As is typical for randomized trials, the two intervention groups were well matched. For our primary outcome, we found that intraurethral 4% lidocaine did not change voiding efficiency during post-randomization uroflow. It also did not alter the four typical parameters we look at for bladder sensation during complex histometry. During micturition pressure flow studies, there were no differences between groups in voiding efficiency, increased abdominal recruitment, pelvic floor muscle activity, or intermittent flow patterns. Because we wanted to know if our uroflow parameters predict the group receiving lidocaine, a logistic regression analysis was performed. We were able to correctly classify 87.5% of those receiving lidocaine and 90% of those receiving placebo based on our uroflow parameters, voided volume, and average flow rate. Interestingly, those receiving the lidocaine exhibited a lower average flow rate per voided volume. There were no differences in pain scores between the placebo and lidocaine groups. However, participants receiving lidocaine demonstrated greater variability in their responses. In conclusion, intraurethral 4% lidocaine does not decrease voiding efficiency. However, we did find differences in flow rate, which may indicate that urethral sensory feedback plays a role in voiding. Additionally, intraurethral 4% lidocaine did not improve pain scores following catheterization. Thank you for your attention. Our disclosures. The authors of this study are a part of the Fellows Pelvic Research Network. Sacral neuromodulation improves bladder control by stimulation of the sacral nerves. In patients with urinary retention, it significantly can increase voided volumes and decrease post-void residual volumes. In patients with overactive bladder, with or without incontinence, it significantly decreases leakage episodes, urgency, and frequency episodes. The objectives of our study are listed here. The primary objective was to evaluate the association of age with device implantation. Sub-analysis was performed to evaluate the association of age with cure, which for purposes of this study were defined as no need for additional therapies after implant. This was a retrospective analysis performed at six institutions with fellowships. Women 18 years or older who had trial phases were included. For the cure analysis, implanted patients were included as long as they had follow-up after their implantation. Bivariate analysis was performed and model selection methods were used to perform a multivariate regression evaluating variables that were associated with device implantation. In similar fashion, variables associated with cure were evaluated in the subset of implanted patients. Median age of our patients, whether they were implanted or not, were in their 60s. Most patients were in the overweight category by BMI, and a simple hysterectomy was the most commonly reported surgical history. We looked at particular comorbidities, and cardiovascular disease was the most commonly reported in our population. Primary indication for the procedure was noted, and overactive bladder was the most common indication in this population. About 60% of the patients included urodynamic, or had urodynamics in their documentation, and the most common findings were acontractile bladder, underactive detrusor, and detrusor overactivity. We looked at information about their testing history, and most of the surgeons or attending physicians present were board certified or subspecialty trained. They were done between 2010 and 2015. The most common testing period was six to ten days, with a first stage timed lead rather than P&E, and they used one lead. Our implantation rate was 89% in approximately 1,000 cases. As expected, the median duration of follow-up varied by the year of testing. Urinary retention patients had a lower odds of implantation than those with an overactive bladder indication. To orient you on this figure, that vertical black line is one, an odds ratio of one. Age, regardless of indication, increasing age by decade, decreased odds of implantation. Increasing BMI, urodynamic stress incontinence, and a prior hysterectomy, increased odds of implantation. Here's some information on our patients who were implanted. And again, that vertical line is one. Age decreased odds of cure after implantation. We found that patients who didn't have a testing phase of six to ten day, a six to ten day period, were less likely to have cure. And in patients who had retention, having underactive detrusor as opposed to a contractile bladder, increased their odds of cure. Patients who had overactive bladder, if they had done prior pelvic floor physical therapy, they were more likely to achieve cure. In conclusion, implantation and cure are affected by age. The comorbidities evaluated in the study did not have a significant effect. Characteristics associated with implantation and cure vary by indication, but one thing that is common is that age, increasing age, appears to affect these things. Finally, patients of greater age do still benefit from sacral neuromodulation. Looking at our population, those that were above 65 years of age still had a high implantation and cure rate. Our study included the typical limitations of a retrospective study, and it is important to note that many of our patients, they had overactive bladder and retention. Thank you. Hello, my name is Georgina Bates and I'm a clinical research fellow at King's College Hospital in London. And thank you for the opportunity to present this work I've done on nocturnal polyuria along with the team at Birmingham. These are our disclosures. So first of all, why is nocturnal polyuria interesting? Well, it's the commonest cause of nocturia in the elderly, and we know that this is a really bothersome low and urinary tract symptom. When women are having to get up two or more times in the night, there's an association with a significant reduction in quality of life. Now, nocturnal polyuria is defined as excessive production of urine during the main sleep period. But despite there being a number of studies that suggest definitions, there is no consensus on the value to describe excessive. So, the aim of our study was first of all to identify the different definitions of nocturnal polyuria, and then to apply these different definitions to a cohort of women attending a urogynecology outpatient clinic to see how the prevalence is affected. So, all women were attending a urogynecology outpatient clinic were asked to fill in a three-day bladder diary. The prevalence of nocturnal polyuria was then calculated using the different definitions. We then calculated positive and negative predictive values for the women who also have significant nocturia. So, this table summarises the different definitions that we found, and we separated these into three different types. The first type being absolute, which describes nocturnal urine production rate with three different cut-offs. The second type is a relative definition, and this is the definition that we most commonly use in the UK. So, based on the assumption that most women spend a third of their day asleep. So, it's abnormal to pass more than a third of your urine at night. The final group is what we call functional definitions, and these take into account the maximum functional capacity with relation to the nocturnal urine volume. So, for example, if a female is passing 300 mils overnight and has a maximum functional capacity of 500 mils, the nocturic index would be 0.6, which is normal by both definitions. We received 500 completed bladder diaries, and then our results are summarised in this table. So, the first column in pink shows how the prevalence changes with the different definitions. As you can see, there is a wide variation. So, nocturnal urine production gives us a result of 23.3% prevalence. This definition was validated in elderly men. And the prevalence goes all the way up to 71.7%. If we look at the next column, that's sub-categorised for women who are voiding two or more times per night, and you can see the prevalence has increased, and it's decreased ac mae'r ymdrechion wedi'u hyrwyddo ar gyfer pob defnyddiad ynglyn â'r dynion sy'n ddim yn ymwneud â'r ymdrechion. Rydyn ni ymwneud â hyn ymlaen, ac mae genedlaethau positif a negatif wedi'u hyrwyddo. Yr hyn rydyn ni'n gallu ei weld eto yw bod yna ddifrifiaeth fawr. Mae'r ymdrechion Nocturia mwyaf na 1.5 yn y defnyddiad sy'n ymwneud â'r ymdrechion positif a negatif mwyaf. Mae'r ymdrechion Nocturia mwyaf na 20 yn y defnyddiad sy'n ymwneud â'r ymdrechion positif a negatif mwyaf. Rydyn ni wedi gwneud ymdrechion ymlaen o boblogaeth ymdrechon sy'n cael eu hysbysu o ddifrifiaethau ymdrechion, felly efallai nad yw'n gallu cael eu hysbysu i boblogaethau gwahanol. Roedd yna nifer o ffactorau nad ydyn nhw'n gallu eu hyrwyddo. Mae'r ymdrechion hon yn cydweithio'r angen ar gyfer standardisio'r terminoleg ar gyfer ymdrechion ymdrechon a'r ymdrechion. Rydyn ni wedi arwain ymdrechion ymdrechion ymdrechon mewn gwirioneddau gwahanol yn y llyfrgell. Mae'n amlwg nad yw'r ymdrechion ymdrechion ymdrechon yn cael eu hysbysu gyda'r ymdrechion ymdrechon mwyaf. Rydyn ni'n cyfrannu bod ymdrechion ymdrechion ymdrechon mwyaf na 1.5 yn ddefnyddiad ddefnyddiol, oherwydd mae ganddyn nhw gwerth positif a negatif. Rydyn ni hefyd yn gwybod bod ymdrechion ymdrechion ymdrechon ymdrechon yn effeithiol ar waith bywyd, felly efallai y byddwn ni'n eisiau ymdrechu hyn pan fyddwn ni'n meddwl am ddefnyddiadau yn y dyfodol neu amgylcheddau cyfnodol yn ymdrechion clinigol. Rydw i eisiau ddiolch, yn enwedig i bob tîm, i Kings a Birmingham, am helpu'r gwaith hon. Diolch am y cyfle hwn i gyflwyno'n ymwneud ag ymdrechion ymdrechon ymdrechon ymdrechon ymdrechon. Y cyflwynod yw, mae fy nifoedd yn cael grant ymwneud â Medtronic. Mae ymdrechon ymdrechon ymdrechon yn ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymd rechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ym drechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon y ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon ymdrechon Therefore, changes to reimbursement policies or possibly device pricing bundles need to be addressed before single-stage sacroineuromodulation can be widely adopted. And we hope future prospective studies can be done to measure additional benefits from a single-stage sacroineuromodulation procedure. Thank you very much. Good afternoon and thank you for the opportunity to present. My name is Michael Gross, and I'm a fourth-year medical student at Stony Brook. We have no disclosures. So, sacroineuromodulation was the first approved third-line treatment for lower urinary tract symptoms in 1997, expanding to an indication for fecal incontinence in 2011. We were curious about the uptake of the procedure over time and what trends, if any, emerged among the different specialties of urology, gynecology, and colorectal surgery. To do this, we looked at the New York State Statewide Planning and Research Cooperative System, or SPARCS, which is a statewide all-payer database that collects from every hospital and ambulatory surgical center throughout the state of New York. Fortunately, sacroineuromodulators have a relatively specific procedural code set, which greatly simplified our search. And so we analyzed both implants and revisions, and stratified by both physician specialty as well as by the presence of fellowship training. In the top graph, you can see the number of implants by urologists in blue, gynecologists are in red, and colorectal surgeons in yellow each year, with the total number of implants in the state shown in the dotted gray line. There were 5,293 implants performed over the period. There was a four-fold increase in implantations by colorectal surgery in yellow between the years 2011 and 2012, which coincided with that FDA approval. The number of implants performed by urologists actually decreased by 3% over the last five years of the period, whereas implants by gynecologists increased by 60%, and the total number of implants grew by 18%. There were 1,774 revisions performed over this period, which follow a similar trend to the implants, just somewhat delayed. The revision rate for each specialty is shown in the table below. Both urology and gynecology had a revision rate of 34%, whereas colorectal surgery had a significantly lower rate of revision at 24%. We then stratified by subspecialty certification, and we found that the number of implants between FPMRS and non-FPMRS-trained gynecologists was relatively balanced. However, almost 80% of the urology implants, or the implants performed by urologists, were performed by those without subspecialty certification. Looking at the revisions, there was a higher rate of revision amongst the FPMRS urologists as compared to non-FPMRS urologists, and the same was true for FPMRS-trained gynecologists versus non-FPMRS-trained gynecologists. There was no significant difference when comparing the FPMRS urologists to the FPMRS gynecologists. We were able to link the revisions to their original surgery in order to determine the median time to revision, which was 19 months. You can see that the revisions appear to be skewed toward the first year or two, with fewer procedures occurring towards the five-year mark, which is the reported battery life of the device, and might be a reason for this procedure. And in these cases that we identified, the implanting and revising surgeon was the same person in 83.2% of the cases. So, in conclusion, over 60% of the interest in implants in New York State occurred over the last five years. We hypothesize that new therapies such as botulinum toxin and mirabegron may have impacted further growth. I realize I just want to jump back here. If we look at the implant graph, the mirabegron was approved in 2012, Botox in 2013, and PTNS began to be reimbursed by Medicare in 2014. So I think that may sort of coincide with some of the leveling off of the trend that we observe here. Jumping back. And then, finally, the revision rate that we document here is approximately 34%, which was, again, the same for urologists and gynecologists. Thank you very much. Good morning, everyone. Thank you for staying here to share all my study on randomized cross-over study on the effect of acupuncture on urinary incontinence and quality of life in women. So I have no disclosure. So as all of you know, urinary incontinence, of course, is a common problem and very disturbing. From the point of view of a traditional Chinese medicine practitioner, although I'm not, I'm a urogynecologist, we're thinking that urinary incontinence could be actually caused by kidney ischemia. That means some kind of deficiency in the kidney function. And acupuncture itself may carry some modulation effects on the nervous system. As shown in this graph, as a basic concept, actually, because from the point of view of TCM, we think the whole body is actually distributed by some meridian distribution, similar to dermatomes like the nervous system. And then there's some kind of energy force, like running through the whole body, that in order to have a good balance over the whole body, then you will have a good body function. So in case if there's any deficiency in the kidney area, then it might cause more urinary incontinence. That's why they have some acupuncture effect, trying to hopefully to improve the symptoms of urinary incontinence in women with kidney ischemia. Because some of the previous studies show some of the beneficial effects, but mainly some small studies. So on overactive bladder symptoms, there are also some small studies showing some favorable effects. That's why somebody is now doing some tibial nerve stimulation. However, they are not targeting towards women with kidney ischemia. That's why this study is trying to look at women with kidney ischemia, whether acupuncture itself can improve their urinary incontinence symptoms and also the quality of life. This is a single-blinded, randomized, cross-over trial with written consent. We targeted all the women with urinary incontinence, and at the same time, the kidney ischemia or deficiency, after assessment by the traditional Chinese medicine practitioner, which is one of our investigators in the study. So we recruited the women, and then excluded those with no kidney ischemia or the decline study, and then randomized them into two groups in a one-to-one ratio. One group received acupuncture first, would get a PEPFLO exercise. The other group, we randomized the group with PEPFLO exercise. And a total six sections of weekly acupuncture treatment will be offered by the same registered TCM practitioner, and with regular follow-up visit afterwards to 24 weeks. Afterwards, we then cross-over the patients into another group, five by five. These are the nine points that we have chosen for acupuncture treatment, mainly on the tummy and also on the lower knee, that we think all these points can treat, targeted towards women with kidney deficiency. And we also calculated the sample size by assuming that 50% of subjects will have improvement in the urinary incontinence after PEPFLO exercise, and with an additional 25% after acupuncture treatment. So with a power of 80%, we estimate the sample size for each arm is around 58. These are the outcome measures, looking at the subjective assessment on improvement in urinary incontinence symptoms, the Fisher Analog Scale and the severity of the symptoms, and the quality of life scores measured by the validated questionnaire UDI6 and also IAQ7, together with a three-day letter diary. So let's look at our results. We have approached 179 women in a recruitment talk, and they are assessed by our TCM practitioner. And then 42 of them declined or excluded because they don't have kidney ischemia, and then 137 of them were randomized into two groups. Group 1 will receive acupuncture first, 69 of them, and a group 2 will receive PEPFLO exercise first. And for this part 1 of the study, for the 69 of them, they all received six weekly sections of acupuncture, and then 67 of them completed follow-up at six weeks, followed by another 12 of them, 67 of them completed the 12-week follow-up, and in between they also advised to continue with PEPFLO exercise in addition to acupuncture. And at the end, 63 of them completed the 24-week follow-up after acupuncture section. And for group 2 of ladies, they received PEPFLO exercise first, 68 of them, and then altogether 60 of them completed the 12-week follow-up, and 59 of them completed the 24-week follow-up. Another part of the study will be across over these two groups of ladies. So for the group 1 of women, they received after acupuncture, now they advised to continue PEPFLO exercise, and 60 of them completed 24 weeks afterwards. And for group 2 of ladies, now we received six acupuncture sections, and 55 of them completed follow-up. So let's look at the demographics of these groups of women. Basically, there's no significant difference among these two groups in our RCT, except that a bit of a mildly higher yearning continence episodes in the three-day flare diary in the group women receiving PEPFLO exercise first. We can't see any subjective improvement in women after acupuncture treatment. However, it's good to know that after acupuncture, we do see improvement in the UDI-6 and also the IIQ-7 score after the acupuncture treatment at both 12 weeks and 24 weeks afterwards. And also, there is also improvement in reduction in severity of the facial analogue scale of the yearning continence after acupuncture and also PEPFLO exercise at 12 and 24 weeks. So only minimal, no major adverse events, some only minor complaints. So, acupuncture treatment is included as we found a certain degree of improvement in the impact of incontinence and aquatic life to women up to 24 weeks afterwards, although there's no change in severity of episodes. Thank you. Botox is the post-void residual and the management of patients who have significant post-void residuals. And this is really analysis of the post-report trials of Botox. These are the disclosures. So, the efficacy of Botox in refractory overactive bladder has been shown in these two multinational Phase III studies. And they did show significant post-void residuals. And the objective of this study is to look in depth at the post-void residuals and assess the impact on the patient and also what the clinicians did. The assessments are the mean change from baseline to post-void residual over time during treatment and to look at the time when there was the maximum post-void residual. Also to subcategorize this maximum post-void residual in terms of 100 mil groups, the time at which post-void residual was to be expected, whether it had an impact on treatment benefit and the rates of intermittent self-catheterization. Now, it's important that during the study, as soon as patients had greater than 350 mil post-void residual, they had to initiate self-catheterization, the patient catheterizing, even if the patient was not symptomatic or the clinician did not wish to initiate catheterization. So, it was an automatic initiation. And here you can see that basically 91% of the patients had less than 200 mil post-void residual and around 66% had less than 100 mil residual. And it's really the 8.5% who had a greater amount. And there was only one patient in this entire study who actually was defined as going into retention. So, all the patients were voiding and there was only one patient who actually went into retention. So, what are the baseline characteristics? And here we can see the maximum post-void residual divided into the 100 mil groups. And I'd like to point out the age, that there is a non-statistically significant trend towards older patients. But again, the numbers are very small. You can see in the greater than 600 mil group, there's only four patients. In the 500-600 mil group, one patient. So, it's difficult to really take a message from this. But certainly there seemed to be a trend of age. And certainly the baseline residual didn't seem to have an impact on whether in predicting whether somebody had large post-void residuals. And here we have a time graph. Again, looking at the maximum post-void residual against time. And the different colours determine the different groups of 100 mil, 200 mils, 400 mils and 600 mils of post-void residual. And you can see the peak is really around two weeks. Though, when looking at any maximum post-void residual, it's around 54 days. But really that was also looking at patients who had only 100 mils in, which we weren't clinically significant. So the clinically significant point is two weeks. And you can see here that the large volumes where we would be worried clinically, were all around that time of two to three weeks. In terms of, did a large maximum post-void residual impact on the treatment benefit? And you can see across here going from 100 mils up to 600 mils. There really is no change in terms of people who had large post-void residuals also did find it beneficial. And the rates of intimate self-catheterisation here, almost 94% did not need to intimate self-catheterise. And it was a small number who did. And the ones who had to self-catheterise were the greater than 350 mil residuals. And here you can see there was one patient who had a residual less than 100 mils who was started on intimate self-catheterisation by the clinician. And you can see that the maximum post-void residual and the percentage having catheterisation, not surprisingly, is associated. So this analysis, it suggests that the vast majority of women do not develop significantly large post-void residuals and over 91% it's less than 200 mils. The significantly raised post-void residuals were in the first six weeks, but more importantly around the two to three week period. And there was a trend with age and that basically did not seem to have an impact on treatment benefit. So this hopefully will allow better counselling in terms of the possible outcomes. But even from this pooled data, we can't really say very much about which patients need to have intimate self-catheterisation because it was part of the protocol. So we don't know what would have been initiated by patients. Thank you very much. So I think we have about two minutes for questions to stay on time. You're welcome to stay if you want to ask more. Questions from the floor. For Dr. Kolar, you went through the process of showing us how you made these categories out of 100 mil increments and I'm curious as to why you didn't just keep that as a continuous variable. You'll have more power to look for your differences if you left that as a continuous variable. I think you're right. From a statistical point of view, it would be better to treat it as a continuous variable because people don't just suddenly change from 199 to 201 mils. But it's more from a graphical representation. But I agree with you. Statistically, it would be better to use it as a continuous variable. A question for Dr. Bain. Your results are kind of similar to the results from the Crimpin study which showed that the ICS definition of nocturnal polyuria is over-inclusive. Do you think it's better to have something that's easy for clinicians to understand and that can be applied across men and women, even if it's not particularly specific? Is it more important for it to be easy for clinicians to understand even if it's not particularly specific? Is it more important for it to be important in clinic or more important for it to work for research purposes? The ICS seem to focus on trying to make better and better definitions but maybe they're too complicated. Thank you. That's a very good question. I agree. I think nocturnal polyuria is definitely not one clinical entity. It's a symptom that has got multiple etiologies to it and whether that's excess fluid intake or anything like that. So I do think a clinical definition is probably much more useful in a clinical setting but not necessarily in trials, which then makes it difficult to transfer. Thank you. And that ends our session. Thank you.

urinary incontinence

sacral neuromodulation

acupuncture

quality of life

post-void residuals

Botox

overactive bladder

nocturnal polyuria