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AUGS/IUGA Scientific Meeting 2019
Best Abstract Presentations - Best Epidemiology Ab ...
Best Abstract Presentations - Best Epidemiology Abstract - Best Abstract by Fellow / Physician in Training
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And please welcome to the stage Dr. Joan Blomquist, the winner of the Best Epidemiological Abstract, who will present her study, Pelvic Flow Muscle Strength and the Incidence of Pelvic Flow Disorders After Vaginal and Caesarean Childbirth. All right, thank you. We'd like to thank the scientific committee for the opportunity to present our study and for the NIH for support of our work. So pelvic floor disorders are associated with childbirth and are more the common 5 to 10 years after a vaginal delivery than after a C-section. As we presented at this meeting last year, the cumulative incidence of SUI, OAB, and prolapse are also higher after a vaginal delivery than after a C-section. We also know that vaginal delivery is associated with weaker pelvic floor muscle strength. For example, the peak pelvic muscle strength as measured by a perineometer is significantly lower among women who've had at least one vaginal delivery than among women who've delivered all their children by C-section. Prior work by our group has shown that weak pelvic floor muscles, along with other factors, such as hiatal strength, account for at least part of the relationship between vaginal delivery and prolapse. As pelvic floor muscle training is a recommended treatment option for pelvic floor disorders, it's possible that weak pelvic floor muscle strength is actually a modifiable risk factor for pelvic floor disorders. As such, it's important for us to understand how pelvic floor muscle strength affects the course and progression of pelvic floor disorders over time. Therefore, the objectives of our study were to investigate the association between pelvic floor muscle strength and the incidence of PFDs, and to determine which maternal and obstetric characteristics, if any, modify the association. This study is one of the primary aims of the Mother's Outcome After Delivery Study, which is a prospective cohort study of Paris women. Participants were recruited five to 10 years after their first delivery, and were followed annually for up to nine years. At each annual visit, they completed questionnaires, including the EPIC, and had a physical exam, including the POPQ exam. For this study, our primary exposure of interest was pelvic floor muscle strength, which we measured with a Paratron perineometer. Previous studies have shown that the Paratron is reproducible and reliable. We measured the average peak pelvic muscle strength on the second annual visit, which on average was 7.7 years from their first delivery, and then we divided participants into two groups based on their pelvic muscle strength. Those with a peak pressure of less than 20 centimeters of water, and those with a peak pressure of greater than or equal to 20 centimeters. Additional covariates included delivery mode, race, parity, age at first delivery, BMI, and the size of the genital hiatus. Our primary outcomes were the four PFDs. Participants were considered to have SUI, OAB, or AI if their EPIC scores were above the previously validated threshold scores, or if they reported prior treatment for that disorder. Pelvic organ prolapse was defined as prolapse beyond the hymen on POPQ, or report of surgery for prolapse. Of the 1,528 mode participants, 1,143 had a Paratron measurement and completed at least two visits, and therefore were included in this analysis. This included 555 participants who delivered all their children by C-section, and 588 who had at least one vaginal delivery. Here you see the demographics at enrollment based on pelvic muscle strength. As expected, participants who had a vaginal delivery had weaker pelvic floor muscle strength. There was a trend towards a higher BMI in the weaker muscle strength group, and there was a larger genital hiatus in the weaker pelvic muscle group. There was no difference between groups with regards to age at first delivery, race, or parity. The number of follow-up visits was equivalent between the groups, making comparison over time feasible. So for our first objective, to describe the cumulative instance of each PFD, we considered first delivery as the time of origin. So for this analysis, we included participants who had the disorder at study entry, as well as those who developed the disorder during the follow-up. We used conventional log-normal models to estimate cumulative instance, and we stratified this analysis by delivery mode. So here you see the cumulative instance for each of the four PFDs over time. In each figure, the blue lines represent the vaginal delivery group, and the red lines represent the cesarean group. The solid lines are those with a peak pressure of less than 20, and the dashed lines are those with a peak pressure of greater than or equal to 20. Within the vaginal delivery group, a peak pressure of less than 20 was associated with a higher cumulative instance of SUI, OAB, and prolapse. TR here stands for time ratio. A time ratio of .67 implies that the time to develop SUI for women with weak muscles is approximately 67% of the time that it would take to develop SUI for women with stronger muscles. Also notice that for the cesarean group, represented by the red lines here, that the instance of each of the four PFDs was similar between the two pelvic muscle strength groups. For our second aim, to determine which maternal and obstetrical characteristics modify the association between pelvic muscle strength and pelvic floor disorders, we excluded participants who already had the disorder at study entry because they could not provide prospective data for us to model hazard. Therefore, we considered five years from first delivery as the time of origin. We used staggered entry methods to deal with the fact that they could've entered the study anywhere between five and 10 years after their first delivery, and we used classical semi-parametric proportional hazard models. Again, we stratified this analysis by delivery mode. Within the vaginal delivery group, a peak pressure of less than 20 was associated with a higher hazard to develop prolapse, but not SUI, OAB, or AI. Remember, we excluded the prevalent cases in this analysis, which is likely why these results look a little different than what we just saw for the cumulative incidence. In the C-section only group, there was no association between pelvic muscle strength and PFDs. Here, we'll look at the multivariable analysis for the vaginal delivery group, which was adjusted for BMI and size of the genital hiatus. As you can see, the association between pelvic muscle strength and prolapse is now attenuated and no longer statistically significant. There was no association between BMI and PFDs in this group, and a larger genital hiatus was associated with a higher hazard of prolapse. In the C-section group, there was no association between pelvic muscle strength and PFDs. Obesity was associated with a higher hazard of SUI, AI, and AI, and a larger genital hiatus was associated with a higher hazard of prolapse. The strengths of our study are its longitudinal design. We used validated tools to measure each of the PFDs. Our size of our study was large enough, and the duration of follow-up was long enough to model differences between groups, and we used time-varying measures. We do have several limitations. Although we had up to nine years of follow-up, this is not long enough to study the association of pelvic muscle strength and incidence of PFDs later in life. And due to the design of the study, we measured pelvic muscle strength several years after first delivery. Ideally, strength would have been measured shortly after delivery to better demonstrate a temporal relationship with the development of PFDs. We also considered pelvic muscle strength to be a constant over time, and our focus studied on peak pelvic muscle strength, which is really only one aspect of pelvic muscle function. So in conclusion, pelvic muscle strength is associated with the cumulative incidence of SUI, OAB, and prolapse among women with at least one voucher delivery, but not among women who delivered by cesarean only. And this association is attenuated when controlling for BMI and genital hiatus. This analysis allows us to identify a group of high-risk women who may benefit from pelvic floor physical therapy as a prevention method. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. We've shown that a forceps delivery in particular is associated with weaker pelvic muscle strength and a higher risk of developing EFDs. And what about cesarean sections? Do you have emergency and elective cesarean sections? For the C-section, so within the C-section group, it includes participants who had C-section without labor, those who got to full dilation, and those who pushed. And in our previous work, we've shown that in those three groups, there's no difference in pelvic muscle strength. And in addition, there's no difference in PFDs. And so that's why we consider them all as one group. Again. Thank you. I wanted to ask a quick question. How did you pick a peak pressure of 20 as your cut point? So we picked a peak pressure of, there's really nothing out there in the literature as to what would be considered strong and what's weak. We did it based on tertiles of our population. So a third of our participants had a peak pressure of less than 20. And did you look at it, do any kind of sensitivity analysis to see if maybe a peak pressure of 10 was more, or if you picked a peak pressure of 30, if there was any differences? Yeah, this was the good cutoff based on those. I have, I'm sorry, I have two or three questions. One is, we are not familiar with a perineometer, and we would like to know what a perineometer is. And could there be a user difference between person to person when they use the perineometer? Does it replace the Oxford scale in the measurement of the pelvic muscle strength? The second thing is, did you stratify your patients according to their race, or that was not entered at all? And looking at your data, it looks like maybe having a C-section, we can avoid all the problems. Thank you. Okay, so the first question was on the Peritron Perineometry. This, it's a compressible device that has a handheld microprocessor with it, and you place it into the vagina and zero it, and then ask the patient to squeeze, which is how you get the pressure. And it's been used in a number of different studies, and has been shown to have a very good correlation with the Oxford scale, and to be reliable and reproducible between different people using it. And we actually did tests within our researchers who were doing it. The second question, race. So we looked at race, and there was not a difference between groups, which is why we didn't stratify this analysis for it. Sorry, we don't have time for any further questions, but I'm sure you'll answer some during the coffee break, yeah? Thank you. Thank you for the opportunity to present our work. And I will be presenting our combined abstracts, Heterogeneity of Patients Undergoing Mesh Removal, and Does Mesh Removal Improve Complication Symptoms? A Prospective Longitudinal Study of Women with Mesh-Related Complications. We would like to thank the NIH for their financial support of this research, and I have nothing to disclose. Mesh is used to improve durability of prolapse and stress incontinence repair. However, its use is limited by complications occurring in two to 18% of women undergoing a urogynecologic procedure involving mesh. The most common complications are exposure through the vaginal epithelium, pain, but also include erosion into an adjacent organ and infection. Mesh exposure can be entirely asymptomatic or associated with pain. Complications are often treated with surgical removal of mesh, and some studies suggest that up to 49% of women undergo surgery as the initial treatment for their mesh complication. There is also some data suggesting that 46% of these patients show no or minimal improvement after surgical removal of their mesh. And there's a lack of consensus regarding the proper management of patients as well as proper patient selection for mesh removal compared to conservative management. Our aims were to characterize patients undergoing surgical removal of mesh and to evaluate long-term outcomes after mesh removal. We conducted a prospective study of women undergoing mesh removal for the treatment of pain or exposure at a major tertiary center in the U.S. between 2013 and 2019. Baseline data were collected prior to surgery and included the patient's medical and surgical history, physical exam, and patient-reported outcome questionnaires. Patients were followed for up to two years with repeated questionnaires six, 12, and 24 months post-operatively. The primary outcome of the study was the patient's global impression of symptom improvement up to two years after undergoing mesh removal. We also assessed patient impression of symptom severity, overall symptom bother, three pain domains, and the overall impact on their daily activities and quality of life. We grouped patients two ways for our analysis according to their primary symptom presentation and the type of mesh that was removed. We compared baseline characteristics and symptoms after mesh removal with Inova, Fisher's Exact, and Wilcoxon rank sum tests, and missing data was addressed with the last value carried forward. A total of 174 patients were analyzed. We compared baseline characteristics and found that patients who underwent mesh removal for pain were younger than patients with exposure alone. There were no differences in BMI, parity, menopausal status, smoking history, opioid use, exposure to chronic steroids, or diabetes among groups. Notably, in our cohort, over 50% of patients had a history of smoking and 25% were current smokers. This number is considerably higher than the U.S. average 14% current smokers according to the CDC. Also, a surprising 44% of patients with pain had active prescriptions for at least one opioid analgesic. We then compared baseline characteristics between sling and prolapse removal groups and found that patients in the prolapse group were on average 10 years older than patients and most of them were post-menopausal. Patients in the sling group had higher BMIs and a higher number were smokers with over 30% having current or a past history of smoking compared to 13% and 27% respectively in the prolapse groups. There were no differences in parity, opioid use, steroid use, diabetes, or among groups. However, we also observed a high opioid use in both groups and they had over, almost half had active prescriptions for opioid medications. In this study, a higher proportion of women in the sling group had mesh removed for pain in the presence or absence of exposure with 50% in both groups having mesh removed for the indication of exposure alone. 59% of women in our study had never undergone a previous surgery or mesh removal for a complication. Additionally, at the time of the study, 45% of patients in our cohort had demonstratable SUI on system metrics and about 50% had pelvic organ prolapse that was stage two or worse. Baseline patient-reported outcomes were worse in patients with pain compared to patients with exposure alone. Patients with pain reported worse symptom bother on the PFDI and their PFIQ scores were three times higher indicating a greater impact on daily function and quality of life. Not surprisingly, patients in the pain group reported higher visual analog pain scores for pelvic pain, dysuria, and dyspareunia. There were no differences in pain scores among patients in the sling and prolapse groups. Patients in our study lived with their symptoms for many years prior to having the mesh surgically excised. The median number of months until symptom onset was between three and 12 months and there were no differences in symptom onset between groups. Patients in all groups waited a median of six to eight years before undergoing mesh removal. Here, we compare PGI severity scores on baseline in red and after mesh removal in gray. Prior to mesh removal, over 60% of patients in all groups reported moderate to severe symptoms on the PGIS. Patients with pain reported severe symptoms, more patients with pain reported severe symptoms and those with exposure with 88% of patients with pain alone and 72% of patients with exposure and pain reporting moderate to severe symptoms compared to 65% of patients with exposure alone. All groups had similar absolute reduction in severe symptoms after mesh removal. However, over 52% of patients in the pain alone group reported persistent moderate to severe symptoms as opposed to only 29% in the exposure alone group. Analysis of our primary outcome, patient global impression of improvement suggests that patients with pain with or without exposure experience less symptom relief after surgical excision of mesh. Women were considered improved if they answered much better or very much better on the PGII and not improved if they reported a little better, no change, a little worse or very much worse. In our study, 68% of women in the exposure group alone improved after mesh removal with only 33% of patients in the pain alone improving. There are several limitations to this study. Even though the database is a large perspective study of patients having surgical removal of mesh, the database does not include patients on conservative management or women who undergo a mesh augmented procedure and have no complications. Additionally, there is likely sampling bias because patients were recruited from a large tertiary referral center. In our analysis, we accounted for missing follow-up data and the last value carried forward and our sensitivity analysis showed no difference between patients with and without missing data. In conclusion, results from the study suggest that smoking rates were high in this cohort of women undergoing mesh removal, particularly in the sling group. Smoking cessation and weight loss should be encouraged prior to sling placement. Opioid use was high in patients reporting pain symptoms because just under half of these women were taking opioids. A high number of women with mesh complications report severe symptoms at baseline and many don't improve after mesh removal. Patients with pain report more severe symptoms at baseline and less improvement after removal of mesh compared to patients with exposure. Mesh removal may not be the optimal treatment for patients with pain as their primary symptom. Future studies are needed to explore the interaction between smoking, opioid use, and mesh complications. And to further characterize the source of pain in women with primarily pain-related complications. We plan to assess risk factors and potential clinical predictors of non-responders to surgical mesh removal as to inform patient expectations regarding treatment outcomes and improve treatment paradigms. I'd like to thank Dr. Mowalli and her wonderful lab for their guidance and support and I'd be happy to take any questions. So, while people are coming up to the microphone, I have a quick question about what symptoms were improving in people who didn't have pain? So just the exposures, what were the symptoms that were assessed? We were assessing the symptoms that are assessed are vague on the PGIS. It asks overall, how would you assess your symptoms now compared to prior then, before the intervention? So we don't have detailed information on what exactly those symptoms are, unfortunately. Are there questions over here? Salman Al-Saleh from Melbourne, Australia. A great study. Have you made a distinction in your study between the complete mesh or sling removal compared to local excisions and cover? As this may have an implication on the overall effectiveness of the treatment. Cover, as this may have an implications in terms of the immediate or long-term, short-term complications, the time consumptions as well as resultant recurrence of urinary tract infections and pelvic organ prolapse. Thanks. Thank you for your question. At our center, all patients who undergo mesh excision and all patients in this study underwent total excision of their mesh. So we did not compare or we were not able to compare partial versus total mesh excision. However, it's possible that because patients undergo complete mesh excision, we may be able to surmise that this is an indicator that the mesh, even without the mesh, they are not improving so that there may be more complex problems going on. I think we have time for one more question over here on the right. Thank you for the study. Really, it's a great database and you really started in an important direction. My question has to do with, does your center treat other types of pelvic pain after excision? For example, hypertonicity. Do you have a physiotherapist involved? And how many of the patient's symptoms, their symptom score or improvement could be attributed to recurrent stress incontinence or prolapse? Two very great questions. So at our center, we do have pelvic floor physical therapy and if patients return with persistent complications after mesh removal, they are then continually treated with physiotherapy and potentially, we also collected data on whether they had had pelvic floor physical therapy prior to mesh removal, but that wasn't reported. I didn't include that in this abstract. And also, that's what I think the question about whether their severity is misinterpreted as then the new onset of worse SUI, OAB, prolapse is a good question. I think we did not assess OAB in this analysis before and after mesh removal, but we did assess slings or stress incontinence and prolapse and while there was a high level before the mesh was removed, there was no change after mesh removal. Some patients did not develop new stress incontinence or worse than prolapse to a statistically significant degree. So it's possible that these symptoms severities are due to their mesh complication and not their pelvic floor disorder, but I can't say for sure. Thank you.
Video Summary
Dr. Joan Blomquist presents a study on pelvic floor muscle strength and its association with pelvic floor disorders (PFDs) after childbirth. The study finds that weak pelvic floor muscle strength is associated with a higher incidence of stress urinary incontinence (SUI), overactive bladder (OAB), and prolapse in women who have had a vaginal delivery. However, this association is not found in women who have delivered via cesarean section. The study also examines other factors such as delivery mode, race, parity, age at first delivery, BMI, and size of the genital hiatus, which may modify the association between muscle strength and PFDs. The study concludes that weak pelvic floor muscle strength is a modifiable risk factor for PFDs and highlights the importance of understanding how muscle strength affects the progression of these disorders over time. The findings suggest that pelvic floor muscle training may be an effective treatment option for PFDs.
Asset Caption
Joan L. Blomquist, MD, Natalie M. Pace
Keywords
pelvic floor muscle strength
pelvic floor disorders
stress urinary incontinence
overactive bladder
prolapse
vaginal delivery
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