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AUGS/IUGA Scientific Meeting 2019
Short Oral Session 8 - Obstetrics
Short Oral Session 8 - Obstetrics
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And these are our disclosures. You've heard earlier today about the important association between the size of the genital hiatus and the development of pelvic organ prolapse. We've heard a little bit about this at the meeting. And the question then arises, there's a very strong relationship here, but what is the, is it a cause and effect relationship? And in order to study that and understand it, we would need to look at the relationship from a temporal perspective. And in any analysis, we would also have to control for childbirth, because vaginal delivery is associated not only with larger genital hiatus, but also with the development of pelvic organ prolapse. And finally, GH, like other measures on the POP-Q exam changes over time. It's not a static measure, so we would need to consider changes in genital hiatus over time. So the objective of this presentation is to explore the relationship between changes over time in the genital hiatus and pelvic organ prolapse in an analysis that controls for childbirth history, as well as time since childbirth. We did this with a nested case control design, in which cases were women who, under a period of observation, developed prolapse. And controls were similar women who did not develop prolapse. So these data come from the Mother's Outcome After Delivery Study, which is a longitudinal cohort study of Paris women. Participants were recruited five to ten years after their first delivery, and followed annually for up to nine years. And this follow-up included annual POP-Q examinations. And a few things about these examinations. The examiners were masked to obstetrical history, and also they were masked to the prior exam. So that's important. And these exams, for this analysis, were used to define prolapse, and also an annual measure of the GH size. We started with 1528 women in the MODE study. We excluded women who came for only one exam. And we excluded people who had prolapse or prolapse surgery at the time of enrollment, because we didn't know about their genital hiatus prior to the study, prior to the development of prolapse. So that left almost 1200 women. And following them over time, we noticed that 153 developed prolapse. So those are our cases. So the cases are these women who developed prolapse during follow-up. And for this study, we defined prolapse as protrusion beyond the hymen. And they were matched to controls who were prolapse-free. These women were observed for the same duration in this study as the cases who developed prolapse. And we matched the controls and cases for childbirth type and years since childbirth. And since we had an abundance of controls, we were able to select five controls at random for every case for this analysis. And then, like I said, we looked at their GH data from the interval prior to the prolapse diagnosis and cases and the similar intervals and controls. And here are our results. In this analysis, we were modeling prolapse as a function of genital hiatus and change in genital hiatus for five years. And what you can see is that the cases at the time of study enrollment and before the development of prolapse had a wider genital hiatus. And that's statistically different. And also, the rate of change in GH leading up to the diagnosis of prolapse was substantially and significantly faster for the cases than in controls. And these results are shown here graphically. The panel on the first side is the GH enrollment. And you can see the distribution of the cases and the medians of their five controls. And each black line connects the case to her five controls. And then, on the other panel, you can see even more dramatically the difference in the rate of change of genital hiatus size over time where there's really almost no overlap in the distribution of those rates. So what are the implications here? We know that the mean GH and the rate of change differ significantly between women with and without prolapse. If this is a cause, as might be suggested by some of the simulation models that we heard presented by Dr. Chen earlier in the meeting, then interventions to narrow the genital hiatus might prevent prolapse. Alternatively, if the GH is a marker, that might help us identify those at risk. This would allow us to target the determinants of genital hiatus size or other risk factors in that group. Some limitations of our study. Our definition of prolapse was fairly simple. Not all prolapse beyond the hymen is burdensome. We didn't consider symptoms. Also, our observations didn't begin until five to ten years from delivery. But some strengths of our study include that the examiners were masked to important factors. We had the opportunity to match cases and controls for relevant confounders. And we had a sufficient sample size and study duration to conduct the study. So in conclusion, women who go on to develop prolapse had a significantly larger GH study entry and had more rapid widening of their GH over time. And this provides a potential monitoring tool to identify those at highest risk. And I'd just like to conclude by thanking the team and the moms who partnered with us for this research. Thank you. Thank you. I'll be presenting our research today on behalf of Dr. Bradley, who's not able to be here. Transvaginal uterus sacral ligament suspension is an effective treatment option for apical pelvic organ prolapse. However, several risk factors for failure of uterus sacral ligament suspension have been identified. One of the risk factors for failure of uterus sacral ligament suspension has been identified. Some of these are age younger than 60, advanced prolapse stage, wide genital hiatus, or a lower preoperative D-point. Our previous retrospective study was the first to demonstrate a correlation between the preoperative D-point and postoperative outcomes. We found that a lower D-point was a risk factor for failure. And we identified a cutoff value of negative 4.25, where women with a D-point that was higher or more negative than negative 4.25 had a failure rate of 1.3, as compared to women who had a D-point that was lower than negative 4.25 with a failure rate of 8.7% at one year or more. This study had some limitations, which included its retrospective design, lack of validated outcomes, and poor long-term follow-up. In order to mitigate these weaknesses, we planned a secondary analysis of the optimal data set. The primary outcome was to determine the relationship between preoperative D-point and postoperative outcomes at 24 months. Our secondary objective was to determine the correlation between the preoperative D-point and anatomic, subjective, and composite success rates. This is a secondary analysis of the optimal trial, which was a randomized, multi-centered study comparing anatomic and subjective outcomes of sacrospinous ligament fixation and utero-sacral ligament suspension. We utilized the two-year data set, which was originally published in 2012. And we included women who had a utero-sacral ligament suspension and concomitant hysterectomy. These are the demographic and clinical parameters that we collected. The optimal study identified failures at 6, 12, and 24 months. And we defined our failures the same way that failures were defined in the optimal study. So apical failure at 6, 12, and 24 months were a C descending more than one-third of the total vaginal length. Anatomic failures were apical failure or prolapse beyond the hymen of the anterior posterior wall. Subjective failures were based on the PFDI results. And composite failures were a combination of anatomic and subjective failures. In total, there were 186 women in the utero-sacral ligament suspension arm of the optimal trial. 48 of these we excluded for having a prior hysterectomy, which left 138 women available to be analyzed. At our 24-month time point, 120 women were available for analysis. We found that a higher preoperative D point correlated with improved postoperative apical support or C point at 24 months. So that each one centimeter descent in preoperative D point resulted in a postoperative C point that was 0.1 centimeters lower. To determine whether this relationship between the preoperative D point and the postoperative C point actually translated to improved anatomic success rates, we plotted an ROC curve. In this curve, which shows sensitivity and specificity, we demonstrate a moderate relationship between the preoperative D point and anatomic failure at 24 months. Again, using this curve, we were able to determine a cutoff point for the preoperative D value that could be used as a predictor of postoperative success. The best cutoff point was found to be negative 4.25, which maximized both sensitivity and specificity. Based on this cutoff value, a woman with a preoperative D point higher than negative 4.25 would be expected to have a failure rate of 14%. Also in this model, a D point lower or more positive than negative 4.25 would yield a 31% anatomic failure rate. In conclusion, we found that the preoperative D point predicts postoperative anatomic and apical support, but it's less successful in predicting subjective outcomes. We found the strongest predictive D point cutoff for anatomic and apical failure at 24 months to be negative 4.25. Thank you. We now have five minutes for questions for these presenters. I'm Steve Swift, Charleston, South Carolina. This is actually for both Dr. Honda and for Dr. Richter. You guys are measuring quarter of a centimeter difference, half of a centimeter difference. Is that clinically applicable? Dr. Honda, I'll go with you first. If my genital hiatus, which I don't have, is 2.8 centimeters, I'm not at risk for prolapse, but if it's 3.3 centimeters, which is that much difference, I am at risk. I'm not sure that it's a good diagnostic test for the reasons you're bringing up, but in terms of thinking about the process of what evolves over time in prolapse, that's where I think the value is. It's super easy to measure that we can all see, and hopefully this will maybe not stand as a diagnostic test, but as something that leads to further insights into the risk factors and the pathophysiology. But have you thought about going back and looking at 2 and 3 and 4 centimeters and doing a positive predictive value, just a simple chi-square, 2 centimeters and beyond, and seeing if you can get a better positive and negative predictive value, so maybe there is at least a counseling tool for patients. Yeah, we've looked at it in categories and other analyses we've done, and it's just the higher the GH, the higher the relative odds for prolapse. And for Dr. Richter, couldn't we just say 4 centimeters instead of 4.25? I think obviously failure and success is all in how we define it, and I think what's really interesting is both the study that we did and if you were in the last session before that reanalyzed the optimal data set at 2 years for GH, we didn't see the same subjective correlation that we saw in anatomic, so that's always important to remember. My question is for Dr. Ward. First of all, thanks, Renee, for looking at something so different and that opens up an opportunity for many mechanistic thoughts and potential studies. But my question is, besides the very gross phenotypic differences like Wiltshire bound versus not, were any of the neurologic testing available to you between the cases and controls? So that's a great question. We didn't look for that. As you can imagine, we're a tertiary care center, so there's a lot of stuff that's done before and then they get here, but that would certainly be an interesting area for future work. I had a question about the point D research, and it's a very interesting observation, and thanks for getting that data. Is it better than point C or point B at predicting failure? That's a great point. Because I only had 5 minutes to present, I'll have to include that in the manuscript, but yes, we did find that there was a unique predictive value that was associated with the D point as compared to the C point. Great, thanks. I'm from Germany. As you said, spina bifida have different characterizations, so different people walking and others are sitting in a wheelchair. Have you also checked for the activity level and also maybe for constipation in your two groups? That's a great question. So in terms of looking at constipation, it was something we wanted to look at initially, and then as we were going through these charts, it's very complicated. And so there's a tremendous amount of constipation, but it's managed very differently. They could have a tract tube, they could have a colostomy. There's a number of ways that it sometimes is managed. And your first part was about mobility? Yeah, and the activity level of dispersion. Yeah, so that would definitely be an area for future research. We were more limited to kind of gross categories for this study. Okay, thank you. I'm from Baltimore. So I have a question for Dr. Ward. So that's a very, very nice presentation, which is very different from lots of studies and also very interesting. So do you have any idea or a theory about why the prolapse is uterine-dominant? And also your study showed that pop increased with the shorter stature. Do you think there will be a causal relationship between these two or just association? So great question. In terms of the height, the height of the uterus I would be interested in looking further if a shorter stature was associated with failure to thrive. I will say that the height data in this population is a little more complex. There were certainly some measurements that were probably done in the wheelchair and we realized we had to exclude. And then in terms of the uterine-predominant prolapse, clinically that is not at least what we see in our research. We probably see more anterior-predominant prolapse. And so it's almost as if this was an animal model where you could do neurologic injury and see what happens to the prolapse. And so this gives us some insight that when there is uterine-predominant prolapse, it's possible there may be more of a neurologic component and that brings up a whole host of additional areas for research. Thank you. Thank you. I think we're done with questions for this time. Thank you all. Okay. Good morning, everyone. My name is Stephanie Handler and I'm presenting this work on behalf of Dr. Takashima. Thanks for giving us the opportunity to share our study. Dr. Takashima had industry funding from Boston Scientific otherwise we have no disclosures. The pudendal nerve block is a well-established, often outpatient treatment for pelvic pain. These injections are often uncomfortable for patients and pudendal nerve blocks may involve multiple injections on both sides of the pelvis. Currently there's no standardized protocol for either the location or the number of pudendal nerve block injections. While there are multiple studies characterizing the course of the pudendal nerve in the cadaveric pelvis, the distribution of commonly used injection sites relative to the pudendal nerve remains unknown. Our objective was to evaluate pudendal block injection spread relative to the pudendal nerve in a cadaveric model. Five fresh cadaveric pelvises were obtained. An injection protocol with four distinct injection sites was developed based on the anatomy of the pudendal nerve as well as on expert opinion. 0.3 milliliters of cadaveric dye was injected at each site. The same surgeon performed all of the injections. We kept the dye quite viscous in an attempt to minimize the dye spread in the cadaver. The black dye was injected one centimeter superior to the ischial spine. The red dye was injected at the ischial spine. The blue dye was injected one centimeter inferior to the ischial spine. And lastly, the green dye was injected two centimeters lateral and two centimeters inferior to the ischial spine. The figure on this slide allows us to refresh our appreciation of the course of the pudendal nerve, especially in relationship to the spine. As you can see, the nerve roots S2, S3, S4 converge to form the pudendal nerve. It exits the pelvis at the greater sciatic foramen and dips just behind the sacrospinous ligament quite close to the ligamentous insertion at the spine and reenters the pelvis through the lesser sciatic foramen and then ultimately dips into Alcox canal. The cadavers were dissected via a posterior approach. The gluteus medius muscle and sacrotuberous ligament were reflected. In our image here, we can see the pudendal nerve from left to right as it exits the pelvis from the greater sciatic foramen, crosses behind the sacrospinous ligament, again quite close to the insertion on the ischial spine, then reenters the pelvis through the lesser sciatic foramen and then ultimately Alcox canal. The center of each injection was measured to two points. One, the shortest distance to any point to the pudendal nerve and two, the shortest distance to the origin of the pudendal nerve. In this image, we can see the spread of our four colors of injection from cephalad to caudad, the black dye, the red dye, the blue dye, the green dye. As you can see, the distance from injection site to any point on the pudendal nerve was quite similar and ranged from 3.0 millimeters to 4.1 millimeters. In conclusion, we found that the precision of the injections is limited even when placed by the same highly skilled provider. However, all the injections were quite close to the nerve along its path, demonstrating accuracy of the injections. The close proximity of all the injections to the pudendal nerve shows that the number of injections might possibly reduce to just one or two, especially in the outpatient setting, which would greatly improve patient comfort. Our ultimate conclusion, based on our small study, was that the pudendal nerve block placed at or one centimeter superior to the ischial spine is probably the best location. Thanks very much. We have no disclosures. Our aim was to evaluate the prevalence and risk factors of anal incontinence three months after delivery. And anal incontinence was defined as leakage of stool and or places once a month or more often. This is a secondary analysis of a previous run of the mouse control trial in the United Kingdom. We found that the prevalence of anal incontinence This is a secondary analysis of a previous run of the mouse control trial evaluating the effect of a 12-week general exercise training program including pelvic floor muscle training. And that was initiated, or the training started at week 18 to 20 during mid-pregnancy. And women were categorized and they were categorized as well as the administrative status, perhaps reporting administrative administrative or no administrative administration, for over two years after a trust. It was in people of 855 ways were included in a room, and 240 ways were reporting administrative administrative symptoms for inclusion during students. Of these, more than 50% reported administrative symptoms for inclusion over two years after trust, as opposed to 23% of administrative men. is administrative administrative reporting for content over two years after trust. When we looked at the risk factors for administrative administration along with all men, we find that there is an admin trust for content and an admin trust for include seriously the risk for administrative administrative after trust. Administrative trust was also related to administrative symptoms and administrative reports. When we looked at the risk factors for admin admin after trust, we find that admin trust for content is about administrative symptoms after administrative reports. There was administrative trust after trust involves increased risk for administrative administration as well. They were quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite 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quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite quite A case-control study was conducted in all five district hospitals in Rwanda. We had a 1-2-2 case-to-control ratio. Cases were Paris women confirmed to have a bladder fistula on examination. Controls were Paris women both with and without urinary incontinence symptoms. Women who consented to be in the study were administered questionnaires on demographics, medical, and reproductive history. All women underwent examination which included clinical pulpimetry. First we conducted bivariate logistic regression. Significant variables were then input into stepwise regression to develop multivariate models. The at-risk scale, variable cutoffs, and the cut point for the high-risk distinction were determined via ROC analysis. Our OF patients were significantly younger, had smaller BMIs, and spent fewer years in school than our controls. Some of the other risk factors include having undergone C-section and sustaining stillbirth. Women with OF were thinner and shorter with smaller foot sizes and shorter legs and narrower hip circumferences. Women with OF were also found to have shorter lengths on all pelvic measurements except for the diagonal conjugate. We found that independent risk factors associated with OF development include many of the aforementioned physical exam findings and having had a stillbirth and undergone C-section. Notably, in our homogenous population, once we controlled for anthropomorphic measurements and having undergone C-section, risk factors associated with OF development previously reported in other literature such as parity and education level were no longer significant. Our next aim was to develop a scale to potentially predict women at risk for obstructed labor and subsequent OF. Cutoff points for the scale were determined through sensitivity and specificity analysis. For the scale, we tested patient characteristics that could lead to the identification of at-risk women before OF development. For example, although stillbirth was an independent risk factor in our study, this was not a variable that can predict the development of obstructed labor and OF as it is the consequence of obstructed labor. Although we primarily used risk factors that were found to be independently associated with OF, we also included other physical exam characteristics such as leg length and hip circumference that were found to improve the accuracy of the scale. Using the score of 4 out of 6 as the high risk distinction has good accuracy with an area under the curve of .79. Two limitations to our study include spectrum bias and selection bias. As we evaluated women in a hospital-based setting, and so they may present with the most severe symptoms, it may not be representative of our target population. The major limitation of this scale is that it requires someone trained in clinical pulvometry to take measurements. Although not well studied, there are programs teaching non-clinicians on performing clinical pulvometry. We also acknowledge the limited literature on the reproducibility and predictive value of clinical pulvometry. It's important to emphasize that a strength of our study is that we did have a control group and the control women were taken from the same population as the cases. In conclusion, anthropomorphic measurements including pelvic dimensions, history of C-section, and stillbirth are independent risk factors for OF development. Importantly, we also developed a risk scale consisting of anthropomorphic measurements including pelvic dimensions to identify at-risk women prior to OF development. Although further work, including external validation, is required before implementation, our at-risk scale is a first step in our ability to identify these women and facilitate their access to care. This ties in well with our previous work where we developed and validated a screening questionnaire to identify women with existing OF symptoms in order to facilitate their care. Thank you. Thank you. We have five minutes now for questions. Hi, I have a question about the pudendal nerve block. Why was the posterior approach rather than the transvaginal approach selected for that study? We thought it might give us better access for our measurements. Okay. I think most OBGYNs have been trained in the transvaginal approach, probably for obstetric labor pain relief, at least we used to be. The posterior approach takes a little bit more experience and I think a longer needle, perhaps actually more penetration to get to the nerve, like you said, three to four centimeters. I think on the vaginal side it should be significantly shorter distance from where the needle enters the epithelium to the nerve is encountered. Did you find that true in any of the cadavers that you looked at? Again, the surgeon who performed these blocks uses the posterior approach, so that's her more regular practice. Since we wanted more homogeneity in the injection practices, and she was going to be the injector, we used her preferred approach. Okay. Thank you. And I've got one last question about that. That's about the dye. I tried to do this in cadavers and the dye didn't seem to stay well where I put it, so I used a very thick, viscous material. Is that how you conquered that problem? The dye comes very, very, very concentrated and there are instructions on how to dilute it and we kept the dye much more viscous and instructive because we had the same problem that you described where the dye would bleed and provide less accurate visual landmarks for us. Okay. Thank you. I had a question for Dr. Krantz about your study. I know you suggested at the end that there may be a multidisciplinary approach to treatment and I know this was a case-controlled study, so you may not have had all the data, but have you seen in your personal practice, because this is a very common finding that I find in my personal practice with my IC patients, and I didn't know if you had seen a difference in the patients who had received treatment for those adverse childhood events versus those who had not yet taken the step to start treating those adverse childhood events. Thank you for that question. So we only included patients in the study who were diagnosed when they presented their first time to clinic because we didn't want that to affect the data. So I think now that we have this information, the next step is to figure out how to, how if increased ACEs can affect treatment and how to work on an approach that can change that like multidisciplinary. Thank you. Hi. I just had one comment about Dr. Handler's, the question that you asked. The injections are actually performed transvaginally as we do as OBGYNs, but the dissection was performed transglutinally. Thank you. All right. I have one more question for the obstetric fistula and kind of the dilemma about being in a low-resource, perhaps insufficiently trained population for doing clinical pelvimetry. It looked like your results of just the foot length and the hip circumference by themselves might give you the information without having to do the clinical pelvimetry. Did you look at just making simple measurements that almost anybody could do, and would that give you enough information to then separate which patients are at risk and which ones could be left to deliver at their village without obstetrical availability for C-section intervention? Yes. Thank you. We did test that, just a model using external measurements that could easily be taken, and it didn't have as high of a sensitivity and specificity as the model including clinical pelvimetry. Okay. Thank you. Hi. I had a question about the obstetric fistulas as well. You mentioned that one of the assumed causes is lack of access to high-quality care. Did you collect any information about what the women with and without fistula might have experienced as barriers to getting care even before their presentation? Actually, a high proportion of both our cases and controls did deliver in a health center or a hospital, over 60% for both for their most recent birth or the birth that they had their fistula during, and they also were both about the same distance away from care, so we don't really know for sure if they were seeking care because they had prolonged labor and needed a C-section because of that, or if they had gone in for a C-section. So that is unknown right now, but we'd like to look into that. Thank you. Thank you for all to our presenters, and I think this concludes this session. Thank you. Thank you.
Video Summary
In this video, several studies are presented with the goal of evaluating various aspects of pelvic organ prolapse (POP) and obstructed labor. <br /><br />The first study explores the relationship between changes in the size of the genital hiatus (GH) over time and the development of POP. The researchers used data from a longitudinal study of Paris women and found that women who went on to develop POP had a significantly larger GH at study enrollment and a faster rate of widening of the GH over time compared to women without POP.<br /><br />The second study focuses on the risk factors for failure of transvaginal uterosacral ligament suspension as a treatment for apical POP. The researchers found that a lower D-point measurement, which indicates the level of descent of the cervix relative to the hymen, was a risk factor for failure of the procedure.<br /><br />The third study investigates the prevalence and risk factors for anal incontinence three months after delivery. The researchers found that younger age, smaller BMI, and having had a stillbirth or C-section were risk factors for anal incontinence after delivery. They also developed a risk scale based on anthropomorphic measurements to identify women at high risk for obstructed labor and subsequent obstetric fistula.<br /><br />Overall, these studies provide insights into the causes, risk factors, and potential interventions for pelvic organ prolapse and obstructed labor. Note: the summaries have been paraphrased for brevity and clarity.
Asset Caption
Hege H. Johannessen, PhD, Mary M. Rieger, MD, Ka Woon Wong, MBBS, MRCOG, Victoria L. Handa, MD, MHS, Renée M. Ward, MD, Sarah E. Bradley, MD, Stephanie J Handler, MD, Tessa Krantz, MD, Annelise Long
Keywords
pelvic organ prolapse
obstructed labor
genital hiatus
longitudinal study
transvaginal uterosacral ligament suspension
risk factors
anal incontinence
obstetric fistula
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