Effect of Postpartum Pessary Use on Pelvic floor Function: A Prospective Multicenter Study

Effect of Postpartum Pessary Use on Pelvic floor Function: A Prospective Multicenter Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Effect of Postpartum Pessary Use on Pelvic floor Function: A Prospective Multicenter Study Franziska Beer, Madeleine Kuppinger, Frank Schwab, Markus Hübner, and 9 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4794963/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 10 Oct, 2024 Read the published version in Archives of Gynecology and Obstetrics → Version 1 posted 5 You are reading this latest preprint version Abstract Purpose This study evaluates the restitution of pelvic floor function in postpartum women using the Restifem® pessary in a preventive and therapeutic approach. Methods In this multicentre study all postpartum women independently of their parity, mode of delivery and existing pelvic floor symptoms were offered to use the Restifem® pessary from 6 weeks postpartum for 3 to 6 months. They completed the validated German pelvic floor questionnaire (GPFQpp) via online survey at 6 weeks, 6 months and 12 months postpartum and were divided, by their own choice, into users and non-users of the pessary. Results Initially 857 women were enrolled. After 6 weeks 137 pessary users and 133 non-users, after 12 months 53 pessary users and 45 non-users submitted a completed questionnaire. Pessary users had significantly higher (worse) scores in all domains of the GPFQpp at 6 weeks postpartum. At 12 months postpartum pessary users still had a significantly higher bladder score, compared to non-users. There was a greater improvement in the bladder score (p = 0.005) and the pelvic organ prolapse score (p < 0.001) from 6 weeks to 12 months postpartum, among pessary users compared to non-users. Conclusion Pessary users had a significantly greater improvement in pelvic floor function from 6 weeks to 12 months postpartum, compared to non-users. This effect might be in part due to wearing the pessary but also due to greater scope for recovery, given the higher level of pelvic floor dysfunction in the pessary user group. Trial registration The trial was registered in the German Clinical Trials Register (DRKS00024733) on 19 of April 2021. Restifem® pessary pelvic floor dysfunction – postpartum pelvic floor therapy- German pelvic floor questionnaire for pregnant and postpartum women Figures Figure 1 Figure 2 Figure 3 What does this study add to clinical work? This prospective study evaluates the effect of the Restifem® pessary, developed for pelvic floor restitution in postpartum women by using the validated German pelvic floor questionnaire for pregnant and postpartum women (GPFQpp). Pessary users had higher (worse) scores in pelvic floor function and over time an increased improvement in pelvic floor symptoms compared to women not using the pessary after 12 months postpartum. Introduction Pelvic floor dysfunction, such as urinary incontinence, faecal incontinence and pelvic organ prolapse (POP), affects approximately 30% of all women [ 1 , 2 ]. Pregnancy and childbirth are considered primary risk factors for these conditions. The literature reports a prevalence of urinary incontinence of 7–36% at 6–13 weeks postpartum, and 11–51% at 12 months postpartum (3). Pelvic floor muscle training (PFMT) reduces the occurrence of urinary incontinence, during pregnancy and postpartum. However, the effectiveness of postpartum PFMT for preventing and treating urinary incontinence or prolapse is limited [ 4 – 6 ]. The cause of postpartum pelvic floor dysfunction is the trauma to muscle, nerve, and connective tissue [ 7 – 9 ]. To facilitate the healing of muscle and connective tissue after injury, early mobilization and stabilization with medical devices is a common therapeutic approach in orthopaedics [ 10 ]. There are two small, prospective studies evaluating the effect of postpartum pessary use on incontinence and POP showing a reduction in incontinence - and POP symptoms [ 11 , 12 ]. The Restifem® (Restitutio feminina) pessary was developed specifically for postpartum women and is approved for the treatment of postpartum POP and stress urinary incontinence (SUI). Its shape is precisely adapted to the female pelvic floor, therefore it strengthens the levels of support along the lateral vaginal wall (Level II), the uterus (Level I) and, suburethral, the anterior vaginal wall (Level III) [ 13 , 14 ]. It is thereby relieving pressure on the muscular and connective tissue structures of the pelvic floor. We confirmed the applicability of Restifem® pessaries, by showing that the use of the pessary could reduce symptoms of prolapse, urinary incontinence and overactive bladder (OAB) 6 months postpartum. The primary outcome of this published study was applicability and compliance and so the questionnaire was not validated for assessment of pelvic floor disorders [ 15 ]. Therefore, the objective of the present analysis was to compare the restitution of pelvic floor function in women using the Restifem® pessary in comparison to women not using the pessary. Women received the pessary independently of pelvic floor symptoms, thus enabling us to investigate its therapeutic and preventive effect. It was the hypothesis of this trial, that symptomatic women were more likely to use the pessary and that their improvement of symptoms would be greater that non-users. Methods The study was approved by local ethics committees and registered at the DRKS (DRKS00024733). Study population The study was conducted in three tertiary care hospitals in Germany in 2021. Inclusion criteria were age over 18 years, to command German language and given informed consent. Exclusion criteria were inflammation of the vagina, allergy to silicone or not being able to handle the pessary. Women were included on the 1st/2nd day postpartum and pessary was handed out [ 15 ]. After 6 weeks postpartum participants received an email, reminding them to start wearing the pessary, along with a link to an instructional video. Restifem® The Restifem® pessary is made of a tissue-compatible silicone, and its shape is adapted to the anatomy of the vagina. It was developed specifically for women postpartum, the manufacturer´s recommendation being to start using it at 6 weeks postpartum and to continue use for 3 to 6 months following the birth. Online survey LimeSurvey® Software versions 3.27.4 was used at intervals of 6 weeks, 6 months and 12 months, during which time postpartum participants received the GPFQpp online. Additionally, women answered the question, whether they still use the pessary [ 15 ]. Primary and secondary endpoints The primary endpoint of the study was the change in the four scores of the validated GPFQpp from 6 weeks postpartum to 12 months postpartum in pessary users compared to non-users. Secondary objectives were the impact of the pessary on symptoms and distress of pelvic floor dysfunction. Questionnaire The validated German Pelvic Floor Questionnaire for pregnant and postpartum women (GPFQ p) comprises the domains of bladder-, bowel-, prolapse- and sexual function and evaluates the impact on quality of life during pregnancy and postpartum [ 16 ]. Statistical Analysis To answer the primary question, we compared the individual scores of the 4 domains of the GPFQpp 6 weeks postpartum and 12 months postpartum between pessary users and non-users. Twelve women reported still wearing the pessary after 12 months postpartum; these were not included in the analysis to avoid potential influence of the pessary usage on the results. To calculate the improvement of scores over time, from 6 weeks postpartum to 12 months postpartum, the difference between the score at 12 months postpartum and 6 weeks postpartum was computed for each group. To address the question of which factors influence pessary usage, we analysed the data 6 weeks postpartum, from women who still completed the questionnaire 6 months postpartum. In the descriptive analysis, number and percent’s, mean with standard deviation (SD) and median and interquartile range (IQR) were calculated depending of distribution of parameters. Differences between groups were tested using Chi-square test or Wilcoxon rank sum test for independent sample. Differences within individuals were tested using Wilcoxon rank sum test for paired sample. All analyses were exploratory in nature and performed with IBM SPSS statistics version 29.0 (Armonk, New York, United States). Results 1: Differences in pelvic floor function 6 weeks postpartum between pessary users and non- users Pessary users were those who reported wearing the pessary at least at one of the four time points 8 weeks, 3 months, and/or 6 months postpartum. Non-users consisted of those who initially opted against pessary use and those who initially chose pessary use, but reported at 8 weeks postpartum not wearing it [15]. Initially 857 women were enrolled on the 1st/2nd day postpartum with a high drop-out rate at 6 weeks, 6 months and 12 months postpartum (Figure 1) In the 6 months postpartum observed group among the pessary users significantly more women reported having a family history of pelvic floor dysfunction, compared to non-users (31.6% versus 11.7%; p= 0.007). There was no significant difference between the groups in the areas of weight, age, number of births, birth weight of the heaviest child and higher-grade perineal tears. Scores: Women who used the pessary had significantly higher (worse) scores in the bladder, bowel, POP and sexual domain of the GPFQpp, 6 weeks postpartum, compared to the non-users (Table 1 and Figure 2). Symptoms: Symptomatic women were defined as those who reported in the GPFQpp symptoms of SUI, OAB, or POP. Women with symptoms of SUI were those who answered the question “Do you leak with coughing, sneezing, laughing or exercising? “ (S6) with „occasionally- less than once per week“ (2), „frequently – once or more per week“ (3) or „daily“ (4). Women with symptoms of OAB were those who answered the question „Do you need to rush/hurry to pass urine when you get the urge?“ (S4) and or “Does urine leak when you rush or hurry to the toilet or can’t you make it in time?“ (S5) with 2,3, or 4. Women with symptoms of POP were those who answered one of the following questions with 2,3, or 4: „Do you have a sensation of tissue protrusion/lump/bulging in your vagina?" (U1), „Do you experience vaginal pressure or heaviness or a dragging sensation?“ (U2) or „Do you have a feeling of vaginal or uterus prolapse when lifting, walking, or running?“ (U3). Pessary users reported significantly higher rates of SUI at 6 weeks postpartum. There were no significant differences in symptoms of an OAB or POP (Table 2). Distress: Women with distress were those who indicated in the GPFQpp that urinary loss and/or symptoms of prolapse affected their daily life and/or reported finding the symptoms of prolapse bothersome. We defined distress due to SUI when women answered the question “Does urine loss affect your daily life? (e.g., sports, work, shopping, socializing) “(S15) with „a little“ (3), „quite a bit“ (4), „very much“ (5). We defined distress due to POP when women answered one of the following questions with 3,4, or 5: „Does prolapse affect your daily life? “ (U4) and or „How much does your prolapse bother you?“ (U5). In the group of pessary users, there was a significantly higher level of distress due to incontinence and/or prolapse at 6 weeks postpartum, compared to non-users (Table 2). 2. Changes in pelvic floor function 12 months postpartum in pessary users vs non-users Scores: After 12 months, N=98 women completed the questionnaire. The pessary users still had a significantly worse bladder score compared to non-users. However, there was no significant difference anymore in the bowel-, sex- or POP score between the two groups (Table 3). Table 3. Scores of the German Pelvic Floor Questionnaire for pregnant and postpartum women after 12 months postpartum of pessary users and non-users in N=98 women who still completed the questionnaire 12 months postpartum. The higher the score, the more symptoms exist. Therefore, the improvement is greater the smaller the value of the difference. A negative value implies an improvement and a positive value an increase in symptoms. There was a greater improvement in the bladder score and the POP score among the pessary users compared to the non-users (Table 4 and Figure 3). Regarding the improvement over time in one group, pessary users had significantly lower bladder and POP scores at 12 months postpartum compared to 6 months postpartum, whereas the improvement among non-users was not significant (Figure 3). Significance was tested with Wilcoxon ranksum test for paired sample. Symptoms: Pessary users had significantly higher rates of SUI and OAB after 12 months postpartum compared to non-users. There was no significant difference in terms of symptoms of POP (Table 5). When calculating the improvement there was no significant difference in improvement concerning symptoms due to SUI and OAB between the two groups. However, there was a greater improvement over time of symptoms of POP regarding the questions U1 , U2 and U3 of the GPFQpp among pessary users compared to non-users (Table 4). Distress: There was no significant difference in terms of level of distress due to incontinence and/or prolapse 12 months postpartum among pessary users compared to non-users (Table 5). Discussion The aim of our study was to evaluate the effect of the Restifem® pessary in reconstitution of pelvic floor function postpartum in a preventive and therapeutic approach. Therapy of pelvic floor dysfunction postpartum Pelvic floor disorders postpartum are common and risk factors such as age at first delivery and obesity are increasing [3]. During labour trauma to muscle, nerve, and connective tissue can lead to pelvic floor disorders [7-9] Although these symptoms are common, not all women find them bothersome. Therefore, it is important to identify those who suffer and implement an appropriate therapy for those women [17]. Treating and preventing urinary incontinence or POP with PFMT is limited [4-6, 18]. In contrast to PFMT, the therapeutic approach of the Restifem® pessary focuses on stability which is a common therapy in orthopaedic disease [10]. For this reason, the Restifem® pessary provides us with an exciting opportunity for a new approach in the therapy and prevention of postpartum pelvic floor disorder. So far there are two small, prospective studies evaluating the effect of postpartum pessary use on incontinence and POP showing a reduction in incontinence and POP symptoms [11, 12]. Motivational factors Alewijnse et al describe determinants of adherence to pelvic floor muscle exercise for women with urine incontinence. Beliefs and illness as well as outcome expectations and perceived severity of symptoms were determinants for adherence [20]. In our study, 6 weeks postpartum, the group of pessary users showed significantly higher (worse) scores in all 4 domains of the GPFQpp, more frequent symptoms of SUI and a higher level of distress regarding incontinence and prolapse. These parameters could be interpreted as illness representation and perceived severity of symptoms and thus determinants for using the pessary. According to the Attitude Social Influence Self-Efficacy (ASE) model variables such as sociodemographic and psychosocial variables are expected to influence behavioural intention [21, 22]. In the group of pessary users, 6 weeks postpartum, a significantly higher frequency of family history for pelvic floor dysfunction was observed, underlining the sociodemographic and psychosocial variables described in the ASE, that may have led to use the pessary. Prevalence and progression over time of symptoms of urinary incontinence and POP postpartum The prevalence of urinary incontinence is relatively heterogeneous. In the literature a prevalence of 7-36% at 6-13 weeks postpartum and 11-51% at 12 months postpartum is reported [3]. Our data in comparison show a higher prevalence of SUI at 6 weeks postpartum for pessary users (55.1%) and non-users (39.5%). At 12 months postpartum pessary users still had a higher prevalence (66.3%) whereas non-users were in line with the above mentioned data (39.5%). This might be due to the fact that our study design motivated especially symptomatic women to take part. Regarding the improvement of symptoms of urinary incontinence 6 weeks to 12 months postpartum, there is no significant difference between both groups of our study population. But at 12 months postpartum pessary users still had a significantly higher frequency of symptoms of SUI (62.3% versus 39.5%) and OAB (54.7% versus 34.1%) compared to non-users. Reimers et al. investigated the prevalence of POP in a cohort of primiparous women up to one year postpartum. They found a 9% prevalence of stage II POP at 6 weeks postpartum and 2% at 12 months postpartum [23]. Another cohort study of primiparous women also showed a decrease in the occurrence of stage II POP in the first year postpartum [24]. In our study, we observed a higher prevalence of POP at 6 weeks and 12 months postpartum. There was no objective examination as in the aforementioned studies and about half of our cohort were multiparous. Our data demonstrate a significant improvement in symptoms of POP from 6 weeks to 12 months postpartum in pessary users compared to non-users. German pelvic floor questionnaire for pregnant and postpartum women Metz et al. developed and validated a questionnaire for the assessment of pelvic floor disorders postpartum. They included nulliparous women who completed the questionnaire in the 3 rd trimester, at 6 weeks, and 12 months postpartum. In this cohort at 12 months postpartum the bladder (1.07) and the POP score (0.86) was higher (worse) compared to 6 weeks postpartum (0.93, 0.76) but not significantly [16]. In our study at 6 weeks non-users had similar mean scores in the bladder (1.1) and POP (0.7) domain, as well as no significant improvement over time, whereas pessary users had higher scores and a significant improvement over the aforementioned time period in the bladder and POP domain. In group comparison pessary users had a significantly greater improvement from 6 weeks to 12 months postpartum, compared to non-users in the bladder and POP score, most likely to a higher level of symptoms in the beginning. But still 12 months postpartum pessary users had significantly higher scores in the bladder domain compared to non-users. Baessler et al evaluated the minimal important difference (MID) which indicates the change in scores that is meaningful to patients [25]. A change of approximately 1 in the scores of the individual domains represents an important difference. In our cohort, in none of the four domains a change in scores of ≥ 1 is reached from 6 weeks to 12 months postpartum among pessary users or non-users. The authors state, that their findings might be specific to the cohort, undergoing an operative therapy, and smaller changes in scores, especially after conservative therapy, could also be significant [25]. Probably the most important factor in describing the impact of pelvic floor disorders on women’s quality of life is distress due to pelvic organ symptoms. Metz et al found that for women with distress postpartum the score of the bladder and POP domain was significantly higher than for those without distress, with a difference in the bladder score of 1.1 and POP score of 3.3 [16]. These differences correspond to the MID. In our study pessary users still had a higher, but not anymore significantly relevant level of distress due to incontinence and/or prolapse 12 months postpartum compared to non-users. Conservative pelvic floor therapy postpartum and normal reparative process over time. Two randomised prospective trails investigating PFMT in postpartum women found an improvement of pelvic floor function postpartum in the intervention as well as in the control group with no significant difference between the groups [5, 6]. Both studies highlight the importance time in pelvic floor recovery. The pelvic floor seems weaken temporarily after childbirth, but contractility appears to recover after 1 year, irrespective of the delivery mode [26]. As our study was not primarily designed to investigate the effectiveness of the pessary, it cannot finally be clarified whether the significantly greater improvement in the bladder and POP score, as well as in symptoms due to POP, among pessary users, is caused by wearing the pessary. Another reasonable explanation might be the greater progression over time, due to normal reparative tissue process, as in the aforementioned studies. Higher scores in the GPFGpp and a higher level of symptoms, at 6 weeks postpartum are most likely to be due to tissue trauma during labour explaining perhaps the greater improvement over time. Strength and limitations A strength of our study was the prospective and multicentre design. So far this is the first prospective study using a validated questionnaire to investigating the effect of the Restifem® pessary on pelvic floor restitution postpartum, preventively and therapeutically. As our study was not primarly designed to assess the efficacy of the pessary, we did not have randomised controlled design. Women decided themselves whether to wear the pessary, which meant no intervention and control group but users and non-users by choice. Additionally, there was a high drop-out rate. Taken together, especially women with symptoms of pelvic floor disorder were willing to use the pessary and seem to have a benefit. Further, randomised controlled trials are needed to investigate the effect of the pessary for symptomatic women therapeutically and for asymptomatic women in a preventive intention. Conclusion Pessary users had a significantly greater improvement in the bladder and the POP score from 6 weeks to 12 months postpartum, compared to non-users. Whether these effects are due to wearing the pessary or to greater scope for recovery, given the higher level of pelvic floor dysfunction postpartum cannot be clarified in this study. Further studies are needed to investigate the effectiveness of pessary use postpartum. Furthermore, symptoms and distress due to pelvic floor dysfunction alongside a family history, can be seen as motivational factors in willingness to use the pessary. Declarations Authors´ contribution Franziska Beer, manuscript writing, data collection Brenda Kiefner, conceptualization, data collection and management, manuscript writing Frank Schwab, conceptualization, statistical analysis Madeleine Kuppinger, data collection and management Markus Hübner, manuscript writing Anna Nacke, conceptualization, data collection and management Ute Kelkenberg, data collection and management Sabine Schütze, data collection, manuscript editing Anna Lindner, data collection, manuscript editing Lars Hellmeyer, resources Wolfgang Janni, resources Melanie Metz, conceptualization, methodology, Miriam Deniz*, conceptualization, methodology, supervision, manuscript writing Compliance with ethical standard Brenda Kiefner got sponsoring for the participation fee for the IUGA congress 2023 from Viomed. The work was funded by Viomed by providing the pessaries for free All other authors have no conflicts of interest concerning this study Research involves Human Participants Informed consent was obtained from all individual participants included in the study Funding Viomed GmbH supported the work by providing the pessaries for free Competing interests: Brenda Kiefner got sponsoring for the participation fee for the IUGA congress 2023 from Viomed. The work was funded by Viomed by providing the pessaries for free All other authors have no conflicts of interest concerning this study Authors Contributions See above Ethics approval: This study was performed in line with the principles of the Declaration of Helsinki. The study was approved by ethic committee of Ulm (University of Ulm (No 90/21) and Ärztekammer Berlin (No Eth-04/21)) Consent to participate Informed consent was obtained from all individual participants included in the study References Barlow DH, Samsioe G, van Geelen JM. 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Supplementary Files Table1.pptx Table2.pptx Table3.pptx Table4.pptx Table5.pptx Cite Share Download PDF Status: Published Journal Publication published 10 Oct, 2024 Read the published version in Archives of Gynecology and Obstetrics → Version 1 posted Reviewers agreed at journal 30 Jul, 2024 Reviewers invited by journal 27 Jul, 2024 Editor invited by journal 26 Jul, 2024 Editor assigned by journal 24 Jul, 2024 First submitted to journal 24 Jul, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4794963","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":332515406,"identity":"8b9b3e1f-c6be-437f-9486-5a4170714fd3","order_by":0,"name":"Franziska Beer","email":"","orcid":"","institution":"University Hospital Ulm: Universitatsklinikum Ulm","correspondingAuthor":false,"prefix":"","firstName":"Franziska","middleName":"","lastName":"Beer","suffix":""},{"id":332515407,"identity":"1e588f78-dd78-4a03-8684-25fc086461c0","order_by":1,"name":"Madeleine Kuppinger","email":"","orcid":"","institution":"University Hospital Ulm: Universitatsklinikum Ulm","correspondingAuthor":false,"prefix":"","firstName":"Madeleine","middleName":"","lastName":"Kuppinger","suffix":""},{"id":332515408,"identity":"653584ae-df2b-47e8-b113-5609f97f8015","order_by":2,"name":"Frank Schwab","email":"","orcid":"","institution":"Charite Universitatsmedizin Berlin Campus Charite Mitte: Charite Universitatsmedizin Berlin","correspondingAuthor":false,"prefix":"","firstName":"Frank","middleName":"","lastName":"Schwab","suffix":""},{"id":332515409,"identity":"eaab2808-cd58-4fa9-bb39-4cb76b064167","order_by":3,"name":"Markus Hübner","email":"","orcid":"","institution":"University of Freiburg University Library Freiburg: Albert-Ludwigs-Universitat Freiburg Universitatsbibliothek Freiburg","correspondingAuthor":false,"prefix":"","firstName":"Markus","middleName":"","lastName":"Hübner","suffix":""},{"id":332515410,"identity":"4a68e37f-9323-456c-a4b5-8cd25e6d433f","order_by":4,"name":"Brenda Kiefner","email":"","orcid":"","institution":"University Hospital Ulm: Universitatsklinikum Ulm","correspondingAuthor":false,"prefix":"","firstName":"Brenda","middleName":"","lastName":"Kiefner","suffix":""},{"id":332515411,"identity":"a0e3d565-2b00-46eb-a1da-a81a5cc0ca89","order_by":5,"name":"Anna Nacke","email":"","orcid":"","institution":"Vivantes Clinic in Friedrichshain: Vivantes Klinikum im Friedrichshain","correspondingAuthor":false,"prefix":"","firstName":"Anna","middleName":"","lastName":"Nacke","suffix":""},{"id":332515412,"identity":"b9382002-ec51-4e0b-8eaa-03e5db756e46","order_by":6,"name":"Ute Kelckenberg","email":"","orcid":"","institution":"Klinikum Bielefeld Mitte: Klinikum Bielefeld gemGmbH","correspondingAuthor":false,"prefix":"","firstName":"Ute","middleName":"","lastName":"Kelckenberg","suffix":""},{"id":332515413,"identity":"5047f8ce-c593-43ec-a04c-11e636fbceae","order_by":7,"name":"Sabine Schütze","email":"","orcid":"","institution":"University Hospital Ulm: Universitatsklinikum Ulm","correspondingAuthor":false,"prefix":"","firstName":"Sabine","middleName":"","lastName":"Schütze","suffix":""},{"id":332515414,"identity":"8965e506-0815-4cba-8669-e01426072341","order_by":8,"name":"Anna Lindner","email":"","orcid":"","institution":"University Hospital Ulm: Universitatsklinikum Ulm","correspondingAuthor":false,"prefix":"","firstName":"Anna","middleName":"","lastName":"Lindner","suffix":""},{"id":332515415,"identity":"fe44e82f-c767-4153-8389-302241139679","order_by":9,"name":"Lars Hellmeyer","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Lars","middleName":"","lastName":"Hellmeyer","suffix":""},{"id":332515416,"identity":"41ad8027-4c85-4e31-bb42-753d9043cd77","order_by":10,"name":"Wolfgang Janni","email":"","orcid":"","institution":"University Hospital Ulm: Universitatsklinikum Ulm","correspondingAuthor":false,"prefix":"","firstName":"Wolfgang","middleName":"","lastName":"Janni","suffix":""},{"id":332515417,"identity":"c2f333ef-06db-4acb-8df4-739186b2335d","order_by":11,"name":"Melanie Metz","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Melanie","middleName":"","lastName":"Metz","suffix":""},{"id":332515418,"identity":"ec17351e-0700-4b49-9ae4-f2063e3b6e6d","order_by":12,"name":"Miriam Deniz","email":"data:image/png;base64,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","orcid":"https://orcid.org/0000-0002-7327-7735","institution":"Universitatsklinikum Ulm","correspondingAuthor":true,"prefix":"","firstName":"Miriam","middleName":"","lastName":"Deniz","suffix":""}],"badges":[],"createdAt":"2024-07-24 11:21:57","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4794963/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4794963/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00404-024-07758-x","type":"published","date":"2024-10-10T15:57:23+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":63122891,"identity":"9e152b87-d9ad-4d5a-ad0b-413b01f82d42","added_by":"auto","created_at":"2024-08-23 11:30:56","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":328392,"visible":true,"origin":"","legend":"\u003cp\u003eTime table and return rate of evaluable questionnaires\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4794963/v1/4a2729fd82de4e0e8e39a97b.jpeg"},{"id":63123799,"identity":"3e1a0a0e-3dd6-460c-98b2-d973e0d43fdf","added_by":"auto","created_at":"2024-08-23 11:46:56","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":62716,"visible":true,"origin":"","legend":"\u003cp\u003eScores of the 4 domains of the German Pelvic Floor Questionnaire for pregnant and postpartum women (Bladder, Bowel, Pelvic organ prolapse (POP), Sex) 6 weeks postpartum of pessary users compared to non-users\u003c/p\u003e","description":"","filename":"floatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-4794963/v1/8ac0882b6fc8f23ecf3723c3.png"},{"id":63123350,"identity":"c761e525-a152-40d3-8dc6-a844410a828e","added_by":"auto","created_at":"2024-08-23 11:38:57","extension":"jpeg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":224785,"visible":true,"origin":"","legend":"\u003cp\u003eScore value of the bladder score and pelvic organ prolapse score of the German Pelvic Floor Questionnaire for pregnant and postpartum women 6 months and 12 months postpartum of pessary users and non-users in N=98 women who still completed the questionnaire 12 months postpartum.\u003c/p\u003e","description":"","filename":"floatimage7.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4794963/v1/1f27326addae6af0cdbc0e43.jpeg"},{"id":66597553,"identity":"63ee3898-4b82-4831-9b4a-13fab8335c71","added_by":"auto","created_at":"2024-10-14 16:11:01","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":938813,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4794963/v1/f4ee1b84-5693-462d-b02a-d45d4c1a952e.pdf"},{"id":63122893,"identity":"568106fa-8f96-47ae-b138-66dad05cb1de","added_by":"auto","created_at":"2024-08-23 11:30:57","extension":"pptx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":85100,"visible":true,"origin":"","legend":"","description":"","filename":"Table1.pptx","url":"https://assets-eu.researchsquare.com/files/rs-4794963/v1/412f0390c0f585d3c75dc94e.pptx"},{"id":63122888,"identity":"f70b1d62-5bdc-447b-adfc-fb01bd2380b2","added_by":"auto","created_at":"2024-08-23 11:30:56","extension":"pptx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":86284,"visible":true,"origin":"","legend":"","description":"","filename":"Table2.pptx","url":"https://assets-eu.researchsquare.com/files/rs-4794963/v1/381500fb2944148bcc9b39a2.pptx"},{"id":63123800,"identity":"c4cb492a-4e50-448c-ab84-23fa6e84e6f0","added_by":"auto","created_at":"2024-08-23 11:46:56","extension":"pptx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":91356,"visible":true,"origin":"","legend":"","description":"","filename":"Table3.pptx","url":"https://assets-eu.researchsquare.com/files/rs-4794963/v1/e78e7ead42c5e837ddabb54b.pptx"},{"id":63122895,"identity":"8d9b5f62-3791-4767-93ee-ee3fd052bb0a","added_by":"auto","created_at":"2024-08-23 11:30:57","extension":"pptx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":165602,"visible":true,"origin":"","legend":"","description":"","filename":"Table4.pptx","url":"https://assets-eu.researchsquare.com/files/rs-4794963/v1/30e3b6b10a6bda40c389548d.pptx"},{"id":63123349,"identity":"f9b1a0e1-9fb2-41a5-af29-e09b3dcc9f40","added_by":"auto","created_at":"2024-08-23 11:38:57","extension":"pptx","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":84832,"visible":true,"origin":"","legend":"","description":"","filename":"Table5.pptx","url":"https://assets-eu.researchsquare.com/files/rs-4794963/v1/e2d8071b0caf7cbeccb5d491.pptx"}],"financialInterests":"","formattedTitle":"\u003cp\u003eEffect of Postpartum Pessary Use on Pelvic floor Function: A Prospective Multicenter Study\u003c/p\u003e","fulltext":[{"header":"What does this study add to clinical work?","content":"\u003cp\u003eThis prospective study evaluates the effect of the Restifem\u0026reg; pessary, developed for pelvic floor restitution in postpartum women by using the validated German pelvic floor questionnaire for pregnant and postpartum women (GPFQpp). Pessary users had higher (worse) scores in pelvic floor function and over time an increased improvement in pelvic floor symptoms compared to women not using the pessary after 12 months postpartum.\u003c/p\u003e"},{"header":"Introduction","content":"\u003cp\u003ePelvic floor dysfunction, such as urinary incontinence, faecal incontinence and pelvic organ prolapse (POP), affects approximately 30% of all women [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Pregnancy and childbirth are considered primary risk factors for these conditions. The literature reports a prevalence of urinary incontinence of 7\u0026ndash;36% at 6\u0026ndash;13 weeks postpartum, and 11\u0026ndash;51% at 12 months postpartum (3). Pelvic floor muscle training (PFMT) reduces the occurrence of urinary incontinence, during pregnancy and postpartum. However, the effectiveness of postpartum PFMT for preventing and treating urinary incontinence or prolapse is limited [\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe cause of postpartum pelvic floor dysfunction is the trauma to muscle, nerve, and connective tissue [\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. To facilitate the healing of muscle and connective tissue after injury, early mobilization and stabilization with medical devices is a common therapeutic approach in orthopaedics [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. There are two small, prospective studies evaluating the effect of postpartum pessary use on incontinence and POP showing a reduction in incontinence - and POP symptoms [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003e The Restifem\u0026reg; (Restitutio feminina) pessary was developed specifically for postpartum women and is approved for the treatment of postpartum POP and stress urinary incontinence (SUI). Its shape is precisely adapted to the female pelvic floor, therefore it strengthens the levels of support along the lateral vaginal wall (Level II), the uterus (Level I) and, suburethral, the anterior vaginal wall (Level III) [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. It is thereby relieving pressure on the muscular and connective tissue structures of the pelvic floor.\u003c/p\u003e \u003cp\u003eWe confirmed the applicability of Restifem\u0026reg; pessaries, by showing that the use of the pessary could reduce symptoms of prolapse, urinary incontinence and overactive bladder (OAB) 6 months postpartum. The primary outcome of this published study was applicability and compliance and so the questionnaire was not validated for assessment of pelvic floor disorders [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eTherefore, the objective of the present analysis was to compare the restitution of pelvic floor function in women using the Restifem\u0026reg; pessary in comparison to women not using the pessary. Women received the pessary independently of pelvic floor symptoms, thus enabling us to investigate its therapeutic and preventive effect. It was the hypothesis of this trial, that symptomatic women were more likely to use the pessary and that their improvement of symptoms would be greater that non-users.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e The study was approved by local ethics committees and registered at the DRKS (DRKS00024733).\u003c/p\u003e \u003cp\u003eStudy population\u003c/p\u003e \u003cp\u003eThe study was conducted in three tertiary care hospitals in Germany in 2021. Inclusion criteria were age over 18 years, to command German language and given informed consent. Exclusion criteria were inflammation of the vagina, allergy to silicone or not being able to handle the pessary. Women were included on the 1st/2nd day postpartum and pessary was handed out [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. After 6 weeks postpartum participants received an email, reminding them to start wearing the pessary, along with a link to an instructional video.\u003c/p\u003e \u003cp\u003eRestifem\u0026reg;\u003c/p\u003e \u003cp\u003eThe Restifem\u0026reg; pessary is made of a tissue-compatible silicone, and its shape is adapted to the anatomy of the vagina. It was developed specifically for women postpartum, the manufacturer\u0026acute;s recommendation being to start using it at 6 weeks postpartum and to continue use for 3 to 6 months following the birth.\u003c/p\u003e \u003cp\u003eOnline survey\u003c/p\u003e \u003cp\u003eLimeSurvey\u0026reg; Software versions 3.27.4 was used at intervals of 6 weeks, 6 months and 12 months, during which time postpartum participants received the GPFQpp online. Additionally, women answered the question, whether they still use the pessary [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePrimary and secondary endpoints\u003c/p\u003e \u003cp\u003eThe primary endpoint of the study was the change in the four scores of the validated GPFQpp from 6 weeks postpartum to 12 months postpartum in pessary users compared to non-users. Secondary objectives were the impact of the pessary on symptoms and distress of pelvic floor dysfunction.\u003c/p\u003e \u003cp\u003eQuestionnaire\u003c/p\u003e \u003cp\u003eThe validated German Pelvic Floor Questionnaire for pregnant and postpartum women (GPFQ p) comprises the domains of bladder-, bowel-, prolapse- and sexual function and evaluates the impact on quality of life during pregnancy and postpartum [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eTo answer the primary question, we compared the individual scores of the 4 domains of the GPFQpp 6 weeks postpartum and 12 months postpartum between pessary users and non-users. Twelve women reported still wearing the pessary after 12 months postpartum; these were not included in the analysis to avoid potential influence of the pessary usage on the results. To calculate the improvement of scores over time, from 6 weeks postpartum to 12 months postpartum, the difference between the score at 12 months postpartum and 6 weeks postpartum was computed for each group. To address the question of which factors influence pessary usage, we analysed the data 6 weeks postpartum, from women who still completed the questionnaire 6 months postpartum.\u003c/p\u003e \u003cp\u003eIn the descriptive analysis, number and percent\u0026rsquo;s, mean with standard deviation (SD) and median and interquartile range (IQR) were calculated depending of distribution of parameters. Differences between groups were tested using Chi-square test or Wilcoxon rank sum test for independent sample. Differences within individuals were tested using Wilcoxon rank sum test for paired sample.\u003c/p\u003e \u003cp\u003eAll analyses were exploratory in nature and performed with IBM SPSS statistics version 29.0 (Armonk, New York, United States).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003e1: Differences in pelvic floor function 6 weeks postpartum between pessary users and non- users\u003c/p\u003e\n\u003cp\u003ePessary users were those who reported wearing the pessary at least at one of the four time points 8 weeks, 3 months, and/or 6 months postpartum. Non-users consisted of those who initially opted against pessary use and those who initially chose pessary use, but reported at 8 weeks postpartum not wearing it [15].\u003c/p\u003e\n\u003cp\u003eInitially 857 women were enrolled on the 1st/2nd day postpartum with a high drop-out rate at 6 weeks, 6 months and 12 months postpartum (Figure 1)\u003c/p\u003e\n\u003cp\u003eIn the 6 months postpartum observed group among the pessary users significantly more women reported having a family history of pelvic floor dysfunction, compared to non-users (31.6% versus 11.7%; p= 0.007). There was no significant difference between the groups in the areas of weight, age, number of births, birth weight of the heaviest child and higher-grade perineal tears.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eScores:\u003c/p\u003e\n\u003cp\u003eWomen who used the pessary had significantly higher (worse) scores in the bladder, bowel, POP and sexual domain of the GPFQpp, 6 weeks postpartum, compared to the non-users (Table 1 and Figure 2).\u003c/p\u003e\n\u003cp\u003eSymptoms:\u003c/p\u003e\n\u003cp\u003eSymptomatic women were defined as those who reported in the GPFQpp symptoms of SUI, OAB, or POP. Women with symptoms of SUI were those who answered the question \u0026ldquo;Do you leak with coughing, sneezing, laughing or exercising? \u0026ldquo; (S6) with \u0026bdquo;occasionally- less than once per week\u0026ldquo; (2), \u0026bdquo;frequently \u0026ndash; once or more per week\u0026ldquo; (3) or \u0026bdquo;daily\u0026ldquo; (4). Women with symptoms of OAB were those who answered the question \u0026bdquo;Do you need to rush/hurry to pass urine when you get the urge?\u0026ldquo; (S4) and or \u0026ldquo;Does urine leak when you rush or hurry to the toilet or can\u0026rsquo;t you make it in time?\u0026ldquo; (S5) with 2,3, or 4. Women with symptoms of POP were those who answered one of the following questions with 2,3, or 4: \u0026bdquo;Do you have a sensation of tissue protrusion/lump/bulging in your vagina?\u0026quot; (U1), \u0026bdquo;Do you experience vaginal pressure or heaviness or a dragging sensation?\u0026ldquo; (U2) \u0026nbsp;or \u0026bdquo;Do you have a feeling of vaginal or uterus prolapse when lifting, walking, or running?\u0026ldquo; (U3).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePessary users reported significantly higher rates of SUI at 6 weeks postpartum. There were no significant differences in symptoms of an OAB or POP (Table 2).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDistress:\u003c/p\u003e\n\u003cp\u003eWomen with distress were those who indicated in the GPFQpp that urinary loss and/or symptoms of prolapse affected their daily life and/or reported finding the symptoms of prolapse bothersome. We defined distress due to SUI when women answered the question \u0026ldquo;Does urine loss affect your daily life? (e.g., sports, work, shopping, socializing) \u0026ldquo;(S15) with \u0026bdquo;a little\u0026ldquo; (3), \u0026bdquo;quite a bit\u0026ldquo; (4), \u0026bdquo;very much\u0026ldquo; (5). We defined distress due to POP when women answered one of the following questions with 3,4, or 5: \u0026bdquo;Does prolapse affect your daily life? \u0026ldquo; (U4) and or \u0026bdquo;How much does your prolapse bother you?\u0026ldquo; (U5).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn the group of pessary users, there was a significantly higher level of distress due to incontinence and/or prolapse at 6 weeks postpartum, compared to non-users (Table 2).\u003c/p\u003e\n\u003cp\u003e2. Changes in pelvic floor function 12 months postpartum in pessary users vs non-users\u003c/p\u003e\n\u003cp\u003eScores:\u003c/p\u003e\n\u003cp\u003eAfter 12 months, N=98 women completed the questionnaire. The pessary users still had a significantly worse bladder score compared to non-users. However, there was no significant difference anymore in the bowel-, sex- or POP score between the two groups (Table 3). \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 3.\u003c/strong\u003e Scores of the German Pelvic Floor Questionnaire for pregnant and postpartum women after 12 months postpartum of pessary users and non-users in N=98 women who still completed the questionnaire 12 months postpartum.\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe higher the score, the more symptoms exist. Therefore, the improvement is greater the smaller the value of the difference. A negative value implies an improvement and a positive value an increase in symptoms. There was a greater improvement in the bladder score and the POP score among the pessary users compared to the non-users (Table 4 and Figure 3). Regarding the improvement over time in one group, pessary users had significantly lower bladder and POP scores at 12 months postpartum compared to 6 months postpartum, whereas the improvement among non-users was not significant (Figure 3).\u003c/p\u003e\n\u003cp\u003eSignificance was tested with Wilcoxon ranksum test for paired sample.\u003c/p\u003e\n\u003cp\u003eSymptoms:\u003c/p\u003e\n\u003cp\u003ePessary users had significantly higher rates of SUI and OAB after 12 months postpartum compared to non-users. There was no significant difference in terms of symptoms of POP (Table 5). When calculating the improvement there was no significant difference in improvement concerning symptoms due to SUI and OAB between the two groups. However, there was a greater improvement over time of symptoms of POP regarding the questions U1 , U2 and U3 of the GPFQpp among pessary users compared to non-users (Table 4).\u003c/p\u003e\n\u003cp\u003eDistress:\u003c/p\u003e\n\u003cp\u003eThere was no significant difference in terms of level of distress due to incontinence and/or prolapse 12 months postpartum among pessary users compared to non-users (Table 5). \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe aim of our study was to evaluate the effect of the Restifem\u0026reg; pessary in reconstitution of pelvic floor function postpartum in a preventive and therapeutic approach.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTherapy of pelvic floor dysfunction postpartum\u003c/p\u003e\n\u003cp\u003ePelvic floor disorders postpartum are common and risk factors such as age at first delivery and obesity are increasing [3]. During labour trauma to muscle, nerve, and connective tissue can lead to pelvic floor disorders [7-9] Although these symptoms are common, not all women find them bothersome. Therefore, it is important to identify those who suffer and implement an appropriate therapy for those women [17]. Treating and preventing urinary incontinence or POP with PFMT is limited [4-6, 18]. In contrast to PFMT, the therapeutic approach of the Restifem\u0026reg; pessary focuses on stability which is a common therapy in orthopaedic disease [10]. For this reason, the Restifem\u0026reg; pessary provides us with an exciting opportunity for a new approach in the therapy and prevention of postpartum pelvic floor disorder. So far there are two small, prospective studies evaluating the effect of postpartum pessary use on incontinence and POP showing a reduction in incontinence and POP symptoms [11, 12].\u003c/p\u003e\n\u003cp\u003eMotivational factors\u003c/p\u003e\n\u003cp\u003eAlewijnse et al describe determinants of adherence to pelvic floor muscle exercise for women with urine incontinence. Beliefs and illness as well as outcome expectations and perceived severity of symptoms were determinants for adherence [20]. In our study, 6 weeks postpartum, the group of pessary users showed significantly higher (worse) scores in all 4 domains of the GPFQpp, more frequent symptoms of SUI and a higher level of distress regarding incontinence and prolapse. These parameters could be interpreted as illness representation and perceived severity of symptoms and thus determinants for using the pessary.\u003c/p\u003e\n\u003cp\u003eAccording to the Attitude Social Influence Self-Efficacy (ASE) model variables such as sociodemographic and psychosocial variables are expected to influence behavioural intention [21, 22]. In the group of pessary users, 6 weeks postpartum, a significantly higher frequency of family history for pelvic floor dysfunction was observed, underlining the sociodemographic and psychosocial variables described in the ASE, that may have led to use the pessary.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePrevalence and progression over time of symptoms of urinary incontinence and POP postpartum\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe prevalence of urinary incontinence is relatively heterogeneous. In the literature a prevalence of 7-36% at 6-13 weeks postpartum and 11-51% at 12 months postpartum is reported [3]. Our data in comparison show a higher prevalence of SUI at 6 weeks postpartum for pessary users (55.1%) and non-users (39.5%). At 12 months postpartum pessary users still had a higher prevalence (66.3%) whereas non-users were in line with the above mentioned data (39.5%). This might be due to the fact that our study design motivated especially symptomatic women to take part. Regarding the improvement of symptoms of urinary incontinence 6 weeks to 12 months postpartum, there is no significant difference between both groups of our study population. But at 12 months postpartum pessary users still had a significantly higher frequency of symptoms of SUI (62.3% versus 39.5%) and OAB (54.7% versus 34.1%) compared to non-users.\u003c/p\u003e\n\u003cp\u003eReimers et al. investigated the prevalence of POP in a cohort of primiparous women up to one year postpartum. They found a 9% prevalence of stage II POP at 6 weeks postpartum and 2% at 12 months postpartum [23]. Another cohort study of primiparous women also showed a decrease in the occurrence of stage II POP in the first year postpartum [24]. In our study, we observed a higher prevalence of POP at 6 weeks and 12 months postpartum. There was no objective examination as in the aforementioned studies and about half of our cohort were multiparous. Our data demonstrate a significant improvement in symptoms of POP from 6 weeks to 12 months postpartum in pessary users compared to non-users.\u003c/p\u003e\n\u003cp\u003eGerman pelvic floor questionnaire for pregnant and postpartum women\u003c/p\u003e\n\u003cp\u003eMetz et al. developed and validated a questionnaire for the assessment of pelvic floor disorders postpartum. They included nulliparous women who completed the questionnaire in the 3\u003csup\u003erd\u003c/sup\u003e trimester, at 6 weeks, and 12 months postpartum. In this cohort at 12 months postpartum the bladder (1.07) and the POP score (0.86) was higher (worse) compared to 6 weeks postpartum (0.93, 0.76) but not significantly [16]. In our study at 6 weeks non-users had similar mean scores in the bladder (1.1) and POP (0.7) domain, as well as no significant improvement over time, whereas pessary users had higher scores and a significant improvement over the aforementioned time period in the bladder and POP domain. In group comparison pessary users had a significantly greater improvement from 6 weeks to 12 months postpartum, compared to non-users in the bladder and POP score, most likely to a higher level of symptoms in the beginning. But still 12 months postpartum pessary users had significantly higher scores in the bladder domain compared to non-users. Baessler et al evaluated the minimal important difference (MID) which indicates the change in scores that is meaningful to patients [25]. A change of approximately 1 in the scores of the individual domains represents an important difference. In our cohort, in none of the four domains a change in scores of \u0026ge; 1 is reached from 6 weeks to 12 months postpartum among pessary users or non-users. The authors state, that their findings might be specific to the cohort, undergoing an operative therapy, and smaller changes in scores, especially after conservative therapy, could also be significant\u0026nbsp;[25]. Probably the most important factor in describing the impact of pelvic floor disorders on women\u0026rsquo;s quality of life is distress due to pelvic organ symptoms. Metz et al found that for women with distress postpartum the score of the bladder and POP domain was significantly higher than for those without distress, with a difference in the bladder score of 1.1 and POP score of 3.3 [16]. These differences correspond to the MID. In our study pessary users still had a higher, but not anymore significantly relevant level of distress due to incontinence and/or prolapse 12 months postpartum compared to non-users.\u003c/p\u003e\n\u003cp\u003eConservative pelvic floor therapy postpartum and normal reparative process over time.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTwo randomised prospective trails investigating PFMT in postpartum women found an improvement of pelvic floor function postpartum in the intervention as well as in the control group with no significant difference between the groups [5, 6]. Both studies highlight the importance time in pelvic floor recovery. The pelvic floor seems weaken temporarily after childbirth, but contractility appears to recover after 1 year, irrespective of the delivery mode [26]. As our study was not primarily designed to investigate the effectiveness of the pessary, it cannot finally be clarified whether the significantly greater improvement in the bladder and POP score, as well as in symptoms due to POP, among pessary users, is caused by wearing the pessary. Another reasonable explanation might be the greater progression over time, due to normal reparative tissue process, as in the aforementioned studies. Higher scores in the GPFGpp and a higher level of symptoms, at 6 weeks postpartum are most likely to be due to tissue trauma during labour explaining perhaps the greater improvement over time. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eStrength and limitations\u003c/p\u003e\n\u003cp\u003eA strength of our study was the prospective and multicentre design. So far this is the first prospective study using a validated questionnaire to investigating the effect of the Restifem\u0026reg; pessary on pelvic floor restitution postpartum, preventively and therapeutically.\u003c/p\u003e\n\u003cp\u003eAs our study was not primarly designed to assess the efficacy of the pessary, we did not have randomised controlled design. Women decided themselves whether to wear the pessary, which meant no intervention and control group but users and non-users by choice. Additionally, there was a high drop-out rate.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTaken together, especially women with symptoms of pelvic floor disorder were willing to use the pessary and seem to have a benefit. Further, randomised controlled trials are needed to investigate the effect of the pessary for symptomatic women therapeutically and for asymptomatic women in a preventive intention.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003ePessary users had a significantly greater improvement in the bladder and the POP score from 6 weeks to 12 months postpartum, compared to non-users. Whether these effects are due to wearing the pessary or to greater scope for recovery, given the higher level of pelvic floor dysfunction postpartum cannot be clarified in this study. Further studies are needed to investigate the effectiveness of pessary use postpartum.\u003c/p\u003e \u003cp\u003eFurthermore, symptoms and distress due to pelvic floor dysfunction alongside a family history, can be seen as motivational factors in willingness to use the pessary.\u003c/p\u003e "},{"header":"Declarations","content":"\u003cp\u003eAuthors\u0026acute; contribution\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFranziska Beer, manuscript writing, data collection\u003c/p\u003e\n\u003cp\u003eBrenda Kiefner, conceptualization, data collection and management, manuscript writing\u003c/p\u003e\n\u003cp\u003eFrank Schwab, conceptualization, statistical analysis\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMadeleine Kuppinger, data collection and management\u003c/p\u003e\n\u003cp\u003eMarkus H\u0026uuml;bner, manuscript writing\u003c/p\u003e\n\u003cp\u003eAnna Nacke, conceptualization, data collection and management\u003c/p\u003e\n\u003cp\u003eUte Kelkenberg, data collection and management\u003c/p\u003e\n\u003cp\u003eSabine Sch\u0026uuml;tze, data collection, manuscript editing\u003c/p\u003e\n\u003cp\u003eAnna Lindner, data collection, manuscript editing\u003c/p\u003e\n\u003cp\u003eLars Hellmeyer, resources\u003c/p\u003e\n\u003cp\u003eWolfgang Janni, resources\u003c/p\u003e\n\u003cp\u003eMelanie Metz, conceptualization, methodology,\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMiriam Deniz*, conceptualization, methodology, supervision, manuscript writing\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCompliance with ethical standard\u003c/p\u003e\n\u003cp\u003eBrenda Kiefner got sponsoring for the participation fee for the IUGA congress 2023 from\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eViomed.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe work was funded by Viomed by providing the pessaries for free\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll other authors have no conflicts of interest concerning this study\u003c/p\u003e\n\u003cp\u003eResearch involves Human Participants\u003c/p\u003e\n\u003cp\u003eInformed consent was obtained from all individual participants included in the study\u003c/p\u003e\n\u003cp\u003eFunding\u003c/p\u003e\n\u003cp\u003eViomed GmbH supported the work by providing the pessaries for free\u003c/p\u003e\n\u003cp\u003eCompeting interests:\u003c/p\u003e\n\u003cp\u003eBrenda Kiefner got sponsoring for the participation fee for the IUGA congress 2023 from Viomed. The work was funded by Viomed by providing the pessaries for free All other authors have no conflicts of interest concerning this study\u003c/p\u003e\n\u003cp\u003eAuthors Contributions\u003c/p\u003e\n\u003cp\u003eSee above\u003c/p\u003e\n\u003cp\u003eEthics approval:\u003c/p\u003e\n\u003cp\u003eThis study was performed in line with the principles of the Declaration of Helsinki. The study was approved by ethic committee of Ulm (University of Ulm (No 90/21) and \u0026Auml;rztekammer Berlin (No Eth-04/21))\u003c/p\u003e\n\u003cp\u003eConsent to participate\u003c/p\u003e\n\u003cp\u003eInformed consent was obtained from all individual participants included in the study\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eBarlow DH, Samsioe G, van Geelen JM. A study of European womens\u0026apos; experience of the problems of urogenital ageing and its management. Maturitas. 1997;27(3):239-47. doi: 10.1016/s0378-5122(97)00047-9. PubMed PMID: 9288696.\u003c/li\u003e\n\u003cli\u003eNygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;300(11):1311-6. doi: 10.1001/jama.300.11.1311. PubMed PMID: 18799443; PubMed Central PMCID: PMC2918416.\u003c/li\u003e\n\u003cli\u003eHubner M, Rothe C, Plappert C, Baessler K. Aspects of Pelvic Floor Protection in Spontaneous Delivery - a Review. Geburtshilfe Frauenheilkd. 2022;82(4):400-9. Epub 20220405. doi: 10.1055/a-1515-2622. PubMed PMID: 35392067; PubMed Central PMCID: PMC8983111.\u003c/li\u003e\n\u003cli\u003eWoodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, et al. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020;5(5):CD007471. Epub 20200506. doi: 10.1002/14651858.CD007471.pub4. PubMed PMID: 32378735; PubMed Central PMCID: PMC7203602.\u003c/li\u003e\n\u003cli\u003eSchutze S, Heinloth M, Uhde M, Schutze J, Huner B, Janni W, et al. The effect of pelvic floor muscle training on pelvic floor function and sexuality postpartum. A randomized study including 300 primiparous. Arch Gynecol Obstet. 2022;306(3):785-93. Epub 20220404. doi: 10.1007/s00404-022-06542-z. PubMed PMID: 35377043; PubMed Central PMCID: PMC8977567.\u003c/li\u003e\n\u003cli\u003eAhlund S, Nordgren B, Wilander EL, Wiklund I, Friden C. Is home-based pelvic floor muscle training effective in treatment of urinary incontinence after birth in primiparous women? A randomized controlled trial. Acta Obstet Gynecol Scand. 2013;92(8):909-15. Epub 20130610. doi: 10.1111/aogs.12173. PubMed PMID: 23672520.\u003c/li\u003e\n\u003cli\u003eAllen RE, Hosker GL, Smith AR, Warrell DW. Pelvic floor damage and childbirth: a neurophysiological study. Br J Obstet Gynaecol. 1990;97(9):770-9. doi: 10.1111/j.1471-0528.1990.tb02570.x. PubMed PMID: 2242361.\u003c/li\u003e\n\u003cli\u003eKruger JA, Budgett SC, Wong V, Nielsen PMF, Nash MP, Smalldridge J, et al. Characterizing levator-ani muscle stiffness pre- and post-childbirth in European and Polynesian women in New Zealand: a pilot study. Acta Obstet Gynecol Scand. 2017;96(10):1234-42. Epub 20170728. doi: 10.1111/aogs.13186. PubMed PMID: 28664535.\u003c/li\u003e\n\u003cli\u003eDietz HP. Ultrasound imaging of maternal birth trauma. Int Urogynecol J. 2021;32(7):1953-62. Epub 20210217. doi: 10.1007/s00192-020-04669-8. PubMed PMID: 33595672.\u003c/li\u003e\n\u003cli\u003eKarlsson J, Eriksson BI, Sward L. Early functional treatment for acute ligament injuries of the ankle joint. Scand J Med Sci Sports. 1996;6(6):341-5. doi: 10.1111/j.1600-0838.1996.tb00104.x. PubMed PMID: 9046544.\u003c/li\u003e\n\u003cli\u003eLange S, Lange R, Tabibi E, Hitschold T, Muller VI, Naumann G. Comparison of Vaginal Pessaries to Standard Care or Pelvic Floor Muscle Training for Treating Postpartum Urinary Incontinence: a Pragmatic Randomized Controlled Trial. Geburtshilfe Frauenheilkd. 2024;84(3):246-55. Epub 20240306. doi: 10.1055/a-2243-3784. PubMed PMID: 38455997; PubMed Central PMCID: PMC10917606.\u003c/li\u003e\n\u003cli\u003eBaessler K HKA, Boelke S, Stupin J, Junginger B. Does an early postpartum pessary treatment lead to remission of pelvic organ prolapse after vaginal birth? A pilot study. . Int Urogynecol J 2019, 30(1):S349‐S50. doi: 10.1007/s00192-019-04116-3.\u003c/li\u003e\n\u003cli\u003eDeLancey JO. Anatomic aspects of vaginal eversion after hysterectomy. Am J Obstet Gynecol. 1992;166(6 Pt 1):1717-24; discussion 24-8. doi: 10.1016/0002-9378(92)91562-o. PubMed PMID: 1615980.\u003c/li\u003e\n\u003cli\u003eHuebner M, DeLancey JOL. Levels of pelvic floor support: what do they look like on magnetic resonance imaging? Int Urogynecol J. 2019 Sep;30(9):1593-1595. doi: 10.1007/s00192-019-03986-x. Epub 2019 May 29. PMID: 31143979; PMCID: PMC6707880.\u003c/li\u003e\n\u003cli\u003eKiefner B, Schwab F, Kuppinger M, Nacke A, Kelkenberg U, Schutze S, et al. Evaluating compliance and applicability of postpartum pessary use for preventing and treating pelvic floor dysfunction: a prospective multicenter study. Arch Gynecol Obstet. 2023;308(2):651-9. Epub 20230521. doi: 10.1007/s00404-023-07075-9. PubMed PMID: 37210701; PubMed Central PMCID: PMC10293351.\u003c/li\u003e\n\u003cli\u003eMetz M, Junginger B, Henrich W, Baessler K. Development and Validation of a Questionnaire for the Assessment of Pelvic Floor Disorders and Their Risk Factors During Pregnancy and Post Partum. Geburtshilfe Frauenheilkd. 2017;77(4):358-65. doi: 10.1055/s-0043-102693. PubMed PMID: 28552999; PubMed Central PMCID: PMC5406235.\u003c/li\u003e\n\u003cli\u003eSchutze S, Hohlfeld B, Friedl TWP, Otto S, Kraft K, Hancke K, et al. Fishing for (in)continence: long-term follow-up of women with OASIS-still a taboo. Arch Gynecol Obstet. 2021;303(4):987-97. Epub 20201201. doi: 10.1007/s00404-020-05878-8. PubMed PMID: 33258994; PubMed Central PMCID: PMC7985110.\u003c/li\u003e\n\u003cli\u003eDeLancey JOL, Masteling M, Pipitone F, LaCross J, Mastrovito S, Ashton-Miller JA. Pelvic floor injury during vaginal birth is life-altering and preventable: what can we do about it? Am J Obstet Gynecol. 2024;230(3):279-94 e2. Epub 20240102. doi: 10.1016/j.ajog.2023.11.1253. PubMed PMID: 38168908; PubMed Central PMCID: PMC11177602.\u003c/li\u003e\n\u003cli\u003eHilde G, Staer-Jensen J, Siafarikas F, Engh ME, Bo K. Postpartum pelvic floor muscle training, levator ani avulsion and levator hiatus area: a randomized trial. Int Urogynecol J. 2023;34(2):413-23. Epub 20221123. doi: 10.1007/s00192-022-05406-z. PubMed PMID: 36418566; PubMed Central PMCID: PMC9870957.\u003c/li\u003e\n\u003cli\u003eAlewijnse D, Mesters IE, Metsemakers JF, van den Borne BH. Program development for promoting adherence during and after exercise therapy for urinary incontinence. Patient Educ Couns. 2002;48(2):147-60. doi: 10.1016/s0738-3991(02)00021-6. PubMed PMID: 12401418.\u003c/li\u003e\n\u003cli\u003eDe Vries MD, Piet Kuhlman Self-Efficacy: The Third Factor Besides Attitude and Subjective Norm as a Predictor of Behavioural Intentions Health Education Research. 1988. doi: https://doi.org/10.1093/her/3.3.273.\u003c/li\u003e\n\u003cli\u003eKari B\u0026oslash; BB, Marijke Van Kampen, Siv Morkved Evidence-based physiotherapy for the pelvic floor : bridging science and clinical practice ISBN 9780443101465, p135.2007.\u003c/li\u003e\n\u003cli\u003eReimers C, Staer-Jensen J, Siafarikas F, Saltyte-Benth J, Bo K, Ellstrom Engh M. Change in pelvic organ support during pregnancy and the first year postpartum: a longitudinal study. BJOG. 2016;123(5):821-9. Epub 20150626. doi: 10.1111/1471-0528.13432. PubMed PMID: 26113145.\u003c/li\u003e\n\u003cli\u003eChen Y, Li FY, Lin X, Chen J, Chen C, Guess MK. The recovery of pelvic organ support during the first year postpartum. BJOG. 2013;120(11):1430-7. Epub 20130701. doi: 10.1111/1471-0528.12369. PubMed PMID: 23815232.\u003c/li\u003e\n\u003cli\u003eBaessler K, Mowat A, Maher CF. The minimal important difference of the Australian Pelvic Floor Questionnaire. Int Urogynecol J. 2019;30(1):115-22. Epub 20180807. doi: 10.1007/s00192-018-3724-1. PubMed PMID: 30088031.\u003c/li\u003e\n\u003cli\u003eElenskaia K, Thakar R, Sultan AH, Scheer I, Beggs A. The effect of pregnancy and childbirth on pelvic floor muscle function. Int Urogynecol J. 2011;22(11):1421-7. Epub 20110726. doi: 10.1007/s00192-011-1501-5. PubMed PMID: 21789660.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 5 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"archives-of-gynecology-and-obstetrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"arch","sideBox":"Learn more about [Archives of Gynecology and Obstetrics](https://www.springer.com/journal/404)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/arch/default.aspx","title":"Archives of Gynecology and Obstetrics","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Restifem® pessary, pelvic floor dysfunction – postpartum pelvic floor therapy- German pelvic floor questionnaire for pregnant and postpartum women","lastPublishedDoi":"10.21203/rs.3.rs-4794963/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4794963/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e \u003cp\u003eThis study evaluates the restitution of pelvic floor function in postpartum women using the Restifem\u0026reg; pessary in a preventive and therapeutic approach.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eIn this multicentre study all postpartum women independently of their parity, mode of delivery and existing pelvic floor symptoms were offered to use the Restifem\u0026reg; pessary from 6 weeks postpartum for 3 to 6 months. They completed the validated German pelvic floor questionnaire (GPFQpp) via online survey at 6 weeks, 6 months and 12 months postpartum and were divided, by their own choice, into users and non-users of the pessary.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eInitially 857 women were enrolled. After 6 weeks 137 pessary users and 133 non-users, after 12 months 53 pessary users and 45 non-users submitted a completed questionnaire. Pessary users had significantly higher (worse) scores in all domains of the GPFQpp at 6 weeks postpartum. At 12 months postpartum pessary users still had a significantly higher bladder score, compared to non-users. There was a greater improvement in the bladder score (p\u0026thinsp;=\u0026thinsp;0.005) and the pelvic organ prolapse score (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) from 6 weeks to 12 months postpartum, among pessary users compared to non-users.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003ePessary users had a significantly greater improvement in pelvic floor function from 6 weeks to 12 months postpartum, compared to non-users. This effect might be in part due to wearing the pessary but also due to greater scope for recovery, given the higher level of pelvic floor dysfunction in the pessary user group.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e \u003cp\u003eThe trial was registered in the German Clinical Trials Register (DRKS00024733) on 19 of April 2021.\u003c/p\u003e","manuscriptTitle":"Effect of Postpartum Pessary Use on Pelvic floor Function: A Prospective Multicenter Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-08-23 11:30:51","doi":"10.21203/rs.3.rs-4794963/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2024-07-30T06:07:09+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-07-27T11:52:13+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"Archives of Gynecology and Obstetrics","date":"2024-07-26T10:30:17+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-07-24T16:32:26+00:00","index":"","fulltext":""},{"type":"submitted","content":"Archives of Gynecology and Obstetrics","date":"2024-07-24T07:21:29+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"archives-of-gynecology-and-obstetrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"arch","sideBox":"Learn more about [Archives of Gynecology and Obstetrics](https://www.springer.com/journal/404)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/arch/default.aspx","title":"Archives of Gynecology and Obstetrics","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"ce62fcee-71dd-4294-b6c7-4726a8b0c94f","owner":[],"postedDate":"August 23rd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-10-14T16:07:29+00:00","versionOfRecord":{"articleIdentity":"rs-4794963","link":"https://doi.org/10.1007/s00404-024-07758-x","journal":{"identity":"archives-of-gynecology-and-obstetrics","isVorOnly":false,"title":"Archives of Gynecology and Obstetrics"},"publishedOn":"2024-10-10 15:57:23","publishedOnDateReadable":"October 10th, 2024"},"versionCreatedAt":"2024-08-23 11:30:51","video":"","vorDoi":"10.1007/s00404-024-07758-x","vorDoiUrl":"https://doi.org/10.1007/s00404-024-07758-x","workflowStages":[]},"version":"v1","identity":"rs-4794963","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4794963","identity":"rs-4794963","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}