Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study.

BACKGROUND: The first feasibility study of the OdonAssist inflatable device for use in clinically indicated assisted vaginal birth reported a success rate of 48% with no significant safety concerns. Additional studies exploring the device performance in other clinical settings are warranted before definitive conclusions can be drawn about its safety and efficacy in current practice. OBJECTIVE: This study aimed to investigate the safety and efficacy of the OdonAssist before conducting a randomized controlled trial. STUDY DESIGN: This was an open-label, nonrandomized study of 104 women with a clinically indicated assisted vaginal birth using the OdonAssist at the Besancon University Hospital, France. Data, including those of a nested cohort group of women who had an assisted vaginal birth using vacuum or spatulas because a trained OdonAssist device operator was not available at the time of delivery, were collected. The primary outcome measure was the proportion of successful assisted vaginal births using the OdonAssist. Neonatal outcome data were reviewed at days 1 and 28, and maternal outcomes were investigated up to day 90. RESULTS: Between December 2019 and May 2021, 2191 pregnant women were approached, and 83% (1636/1973) of them consented to participate in the study. Among them, 10.7% (176/1636) required an assisted vaginal birth owing to a vertex presentation at +1 and below. The OdonAssist was used in 59% of births (104/176), and 41.1% (72/176) of the participants were included in the nested cohort group. The rate of successful assisted vaginal births using the OdonAssist was 88.5% (92/104). No emergency cesarean deliveries were performed in the OdonAssist group. There were no serious adverse maternal or neonatal reactions related to the use of the device. The rate of third- and fourth-degree perineal tears with the OdonAssist was 3.8% (4/104). The maternal perception ratings of the birth experience with the OdonAssist (collected on days 1, 7, and 28 using a 15-point scale) were high. In addition, the operators reported a positive perception of the device, with ease of use across the different steps of the procedure. One single technique was used for all vertex fetal head positions. CONCLUSION: The OdonAssist is a safe and effective alternative to other current devices for assisted vaginal births. The high acceptance rate (83%) among pregnant women and the high rate of successful assisted vaginal births using the OdonAssist confirm the feasibility of a future randomized controlled trial.

The impact of pregnancy and childbirth on stress urinary incontinence in women previously submitted to mid-urethral sling: A systematic review and metanalysis.

INTRODUCTION: There is no guideline or clinical consensus concerning the mid-urethral sling (MUS) operation for stress urinary incontinence (SUI) and future pregnancies. The aim of this systematic review and metanalysis is to evaluate the impact of pregnancy and of delivery on SUI in women who previously sustained a MUS surgery. METHODS: We performed a systematic review and meta-analysis, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines, and selected seven publications for inclusion in the analysis. RESULTS: Recurrence of SUI after childbirth in women previously submitted to MUS was 22% (95% confidence interval [CI]: 18.0%-26.0%; I2 = 0%) while the reintervention rate for SUI the 5% (95% CI: 2.0%-8.0%; I2 = 47.34%) in the included studies. There was not statistically significant difference between women who delivered (both vaginally and by caesarian section) or not after MUS in SUI recurrence (RR 1.01, 95% CI 0.73-1.40; p = 0.96 and I2-test of 41% p = 0.18) and in SUI reintervention (RR 1.45, 95% CI 0.91-2.30; p = 0.12 and I2-test of 0% p = 0.38) with homogeneity among studies. There was no difference between women who delivered vaginally or by caesarian section both for recurrence of SUI (RR 1.24, 95%CI 0.77-2.01; p = 0.37 and I2-test of 0% p = 0.60) and reintervention (RR 1.61, 95% CI 0.76-3.42; p = 0.22 and I2-test of 0% p = 0.47). BMI ≥ 30 kg/m2, urinary incontinence (UI) before and during pregnancy emerged as risk factors for postpartum UI relapse. CONCLUSION: Childbirth do not affect SUI relapse or reintervention in women previously submitted to MUS. In the same population of patients, no difference was highlighted concerning the mode of delivery for the outcome SUI relapse or reintervention. Previous MUS surgery may not be an appropriate indication for cesarean birth in subsequent pregnancy.

In vitro biomechanical properties of porcine perineal tissues to better understand human perineal tears during delivery.

INTRODUCTION: Data concerning the mechanical properties of the perineum during delivery are very limited. In vivo experiments raise ethical issues. The aim of the study was to describe some of the biomechanical properties of each perineal tissue layer collected from sows in order to better understand perineal tears during childbirth. MATERIAL AND METHODS: Samples of each perineal tissue layer were obtained from the skin, the vagina, the external anal sphincter (EAS), the internal anal sphincter (IAS), and the anal mucosa of fresh dead sows. They were tested in quasi-static uniaxial tension using the testing machine Mach-1®. Tests were performed at a displacement velocity of 0.1 mm·s-1. Stress-strain curves of each perineal tissue layer before the first damage for each sow were obtained and modeled using a hyperelastic Yeoh model described by three coefficients: C1, C2, and C3. Pearson correlation coefficients were calculated to measure the correlation between the C1 hyperelastic coefficient and the duration between the first microfailure and the complete rupture for each perineal tissue layer. Pearson correlation was computed between C1 and the number of microfailures before complete rupture for each tissue. RESULTS: Ten samples of each perineal tissue layer were analyzed. Mean values of C1 and corresponding standard deviations were 46 ± 15, 165 ± 60, 27 ± 10, 19 ± 13, 145 ± 28 kPa for the perineal skin, the vagina, the EAS, the IAS, and the anal mucosa, respectively. According to this same sample order, the first microfailure in the population of 10 sows appeared at an average of 54%, 27%, 70%, 131%, and 22% of strain. A correlation was found between C1 hyperelastic coefficient and the duration between the first microfailure and the complete rupture (r = 0.7, p = 0.02) or the number of microfailures before complete rupture only for the vagina (r = 0.7, p = 0.02). CONCLUSIONS: In this population of fresh dead sow's perineum, the vagina and the anal mucosa were the stiffest tissues. The IAS and EAS were more extensible and less stiff. A significantly positive correlation was found between C1 and the duration between the first microfailure and the complete rupture of the vagina, and the duration between the first microfailure and the complete rupture of the vagina.

Midterm complications after primary obstetrical anal sphincter injury repair in France.

BACKGROUND: Incidence of complications following obstetrical anal sphincter injury (OASI) during vaginal delivery are poorly defined. They are only studied in high level maternities, small cohorts, all stages of perineal tear or in low-income countries. The aim of our study was to describe complications after primary OASI repair following a vaginal delivery in all French maternity wards at short and midterm and to assess factors associated with complication occurrence. METHODS: We conducted a historical cohort study using the French nationwide claim database (PMSI) from January 2013 to December 2021. All women who sustained an OASI repair following a vaginal delivery were included and virtually followed-up for 2 years. Then, we searched for OASIS complications. Finally, we evaluated factors associated with OASIS complication repaired or not and OASIS complication repairs. RESULTS: Among the 61,833 included women, 2015 (2.8%) had an OASI complication and 842 (1.16%) underwent an OASI complication repair. Women were mainly primiparous (71.6%) and 44.3% underwent an instrumental delivery. During a follow-up of 2 years, 0.6% (n = 463), 0.3% (n = 240), 0.2% (n = 176), 0.1% (n = 84), 0.06% (n = 43) and 0.01% (n = 5) of patients underwent second surgery for a perineal repair, a fistula repair, a sphincteroplasty, a perineal infection, a colostomy and a sacral nervous anal stimulation, respectively. Only one case of artificial anal sphincter was noticed. Instrumental deliveries (OR = 1.56 CI95%[1.29;1.9]), private for-profit hospitals (OR = 1.42 [1.11;1.82], reference group "public hospital"), obesity (OR = 1.36 [1;1.84]), stage IV OASIS (OR = 2.98 [2.4;3.72]), perineal wound breakdown (OR = 2.8 [1.4;5.48]), ages between 25 and 29 years old (OR = 1.59 [1.17;2.18], refence group "age between 13 and 24 years old") and 30 and 34 years old (OR = 1.57 [1.14; 2.16], refence group "age between 13 and 24 years old") were factors associated with OASIS complication repairs. CONCLUSIONS: Maternal age, stage IV OASIS, obesity, instrumental deliveries and private for-profit hospitals seemed to predict OASIS complications. Understanding factors associated with OASIS complications could be beneficial for the patient to inform them and to influence the patient's follow-up in order to prevent complications, repairs and maternal distress.

Urodynamic Profile and Impact of Surgery in Women Affected by Deep Infiltrating Endometriosis: a Systematic Review and Meta-analysis.

OBJECTIVE: to evaluate the impact of deep infiltrating endometriosis (DIE) on bladder function and the possible impact of surgical resection. DATA SOURCES: A systematic literature research was performed using the PubMed/MEDLINE and EMBASE database (last search date: 30 April 2024). METHODS OF STUDY SELECTION: we included studies that evaluated the urodynamics (UDS) findings in women affected by DIE before submission to surgery. Following epidemiological designs were considered suitable: randomized control trials (RCTs), observational prospective or retrospective studies and case series. Metanalysis was performed using Jamovi Software version 2.3.28 (Sydney, Australia), according to PRISMA 2020 guidelines. Nine publications were included. TABULATION, INTEGRATION, AND RESULTS: Nine studies including 574 women affected by DIE and submitted to urodynamic assessment were included. In women affected by DIE, preoperative detrusor overactivity (DO) was reported in 15% (95% CI 3, 26; I2=93.9%, p<0.001), preoperative voiding dysfunction in 21% (95% CI 12, 29; I2=78.1%, p<0.001) and preoperative low maximum cystometry capacity was shown in 18% (95% CI -2, 38; I2=97.2%, p<0.001). An abnormal bladder sensation was recorded in 39% of patients (95% CI 18, 60; I2=86%, p<0.001), low preoperative bladder compliance was reported in 35% of patient (95% CI 30, 40; I2=0%, p=0.66) and preoperative painful bladder filling was showed in 37% of the evaluated population (95% CI 27, 48; I2=0%, p=0.58). No difference between preoperative and postoperative UDS DO was reported (OR 0.45; 95% CI -0.10, 1.0, I2=0%; p=0.66). Moreover, no difference in preoperative and postoperative voiding dysfunction was reported (OR 0.0; 95% CI -0.76, 0.76, I2=49.6%; p=0.12). CONCLUSION: Abnormal urodynamic findings before surgery are prevalent in women with deep infiltrating endometriosis. Surgery seems not affect UDS outcomes in women affected by DIE. However, heterogeneity among included studies may limit the generalizability of our findings.

Self-care of vaginal pessary for pelvic organ prolapse: a systematic review and meta-analysis.

INTRODUCTION: There is no evidence about the efficacy of self-care of vaginal pessary in women with symptomatic pelvic organ prolapse (POP). The aim of this systematic review and meta-analysis is to assess the adherence to pessary treatment among women who engage in self-management of their pessary. METHODS: We performed a systematic review and meta-analysis, according to PRISMA 2020 guidelines, and selected seven publications for inclusion in the analysis. RESULTS: Pooled continuation rate of self-cared vaginal pessary was the 76% (95%CI: 66-85%) with a I2-test of 93.3% (p < 0.001). Pooled conversion to POP surgery was the 12% (95%CI: 1-23%) with a I2-test of 96% (p < 0.001). Continuation rate was not statistically different between women who were treated by self-care and non-self-care management of vaginal pessary (RR 1.11, 95%CI 0.96-1.27; p = 0.15), with a related I2-test of 37% (p = 0.21). CONCLUSION: Self-care vaginal pessary management presented a high continuation rate in women affected by pelvic organ prolapse at a long follow-up. The rate of conversion to surgical management of POP was low. No significant difference in continuation rate were highlighted between women who adopted the self-care or the clinical-based management of pessary.

The anatomy of the sacrospinous ligament: how to avoid complications related to the sacrospinous fixation procedure for treatment of pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Historically, the sacrospinous ligament (SSL) has been used to treat POP in order to restore the apical compartment through a posterior or an anterior vaginal approach. The SSL is located in a complex anatomical region, rich in neurovascular structures that must be avoided to reduce complications such as acute hemorrhage or chronic pelvic pain. The aim of this three-dimensional (3D) video describing the SSL anatomy is to show the anatomical concerns related to the dissection and the suture of this ligament. METHODS: We conducted a research of anatomical articles about vascular and nerve structures located in the SSL region, in order to increase the anatomical knowledge and show the best placement of sutures to reduce complications related to SSL suspension procedures. RESULTS: We showed the medial part of the SSL to be most suitable for the placement of the suture during SSL fixation procedures, in order to avoid nerve and vessel injuries. However, nerves to the coccygeus and levator ani muscle can course on the medial part of the SSL, the portion of the SSL where we recommended to pass the suture. CONCLUSIONS: Knowledge of the SSL anatomy is crucial and during surgical training it is clearly indicated to stay far away (almost 2 cm) from the ischial spine to avoid nerve and vascular injuries.

Conservative management versus systematic suture of isolated vaginal or first-degree perineal tears after delivery: A preliminary randomized efficacy trial.

BACKGROUND: The objective of this study was to assess the preliminary efficacy and safety of conservative management compared with systematic suture in isolated vaginal or first-degree perineal tears after birth. METHODS: We conducted a preliminary efficacy, open-label, randomized, controlled, and prospective trial. This study implemented Simon's 2-step plan (interim analysis and final analysis) to test the success rate of the digital compression strategy group. Primiparous women aged ≥18 years with isolated vaginal or first-degree perineal tears after spontaneous vaginal birth of a cephalic presenting term (≥37 weeks) neonate were randomly allocated to the conservative management (CM) group (digital compression if bleeding followed by suture if persistent bleeding) or a systematic suture (SS) group. The primary outcome was the success of the intervention 10 days after delivery, defined by pain as evaluated using a visual analog scale < 3, satisfactory healing defined by a REEDA score ≤ 2, and no bleeding or infection. Sexual well-being was assessed at 2 and 6 months postpartum. RESULTS: Among 861/2209 eligible women, 143 consenting women with a superficial perineal tear were randomized: 72 in the systematic suture group and 71 in the conservative management group. Success rate was 87.8% (90% CI [70.5-93.54]) (42/55) in the systematic suture group vs 90% (90% CI [78.3-93.8]) (53/61) in the conservative management group. The REEDA score was significantly higher in the systematic suture group (1.4 vs 0.9; P = 0.036). Perineal pain was significantly higher at day 1 in the systematic suture group (2.38 vs 1.69; P = 0.034). For the Female Sexual Functional Index score, no significant difference was found between the two groups at inclusion or at 2 and 6 months postpartum. CONCLUSIONS: Conservative management of superficial perineal tears shows an efficacy rate ≥90%. Women in the conservative management group had less pain at the 1st day follow-up and lower REEDA scores at the 10th day follow-up.

V-Y advancement flap to correct a perineal defect after an episiotomy dehiscence.

INTRODUCTION AND HYPOTHESIS: Episiotomy scar may be the site of complications and result in wound dehiscence in the long term. The aim of this video article was to describe the surgical steps required to repair a right perineal defect after episiotomy using a V-Y advancement flap. METHOD: Our patient had an episiotomy dehiscence that had already benefited from an end-to-end repair, but the perineal defect recurred. A V-Y advancement flap was performed. The first step of this surgery was to remove the episiotomy scar. A V-shaped flap was then created to fill the perineal defect. Upon advancement, the V flap was transformed in a Y shape and secured using tension-free absorbable sutures. CONCLUSION: There was no flap necrosis, and the esthetic result was satisfactory.

Impact of a selective use of episiotomy combined with Couder's maneuver for the perineal protection.

PURPOSE: To evaluate the impact of a selective use of episiotomy combined with Couder's maneuver on the incidence of perineal tears in spontaneous term deliveries. METHODS: A comparative, retrospective, mono-centric study in a university maternity unit was designed and included all primiparous women who delivered spontaneously after 37 weeks of gestation in cephalic presentation. Two cohorts were studied, before and after the practice of Couder's maneuver. In the first cohort, the ''OSE cohort'' only selective episiotomies were performed from January 2009 to December 2010. In the second cohort, from January 2016 to December 2017, the ''SEC cohort'' selective episiotomies combined with Couder's maneuver were performed by midwives and obstetricians. The primary outcome was the type of perineal tears, according to the Royal College of Obstetricians and Gynaecologists (RCOG) classification. RESULTS: A total of 2081 patients were included: 909 patients in the OSE cohort and 1172 patients in the SEC cohort. Couder's maneuver was performed in 59% of the SEC cohort. In the SEC cohort, there were an increase in the number of intact perinea (55% versus 63%, p < 0.001), a decrease in second-degree perineal tears (18% versus 11%, p < 0.001) and a decrease in labia minora tears (48% versus 37%, p < 0.001). The rate of obstetrical anal sphincter injuries was less than 1% in both cohorts (0.3% versus 0.5%, p = 0.7). CONCLUSION: A selective use of episiotomy combined with Couder's maneuver could reduce the incidence of perineal tears, particularly second-degree perineal tears, without increasing the rate of obstetrical anal sphincter injuries.

Towards the biomechanical modelling of the behaviour of ex-vivo porcine perineal tissues.

The perineum is a layered soft tissue structure with mechanical properties that maintain the integrity of the pelvic floor. During childbirth, the perineum undergoes significant deformation that often results in tears of various degrees of severity. To better understand the mechanisms underlying perineal tears, it is crucial to consider the mechanical properties of the different tissues that make up the perineum. Unfortunately, there is a lack of data on the mechanical properties of the perineum in the literature. The objective of this study is to partly fill these gaps. Hence sow perineums were dissected and the five perineal tissues involved in tears were characterized by uniaxial tension tests: Skin, Vagina, External Anal Sphincter, Internal Anal Sphincter and Anal Mucosa. From our knowledge, this study is the first to investigate all these tissues and to design a testing protocol to characterize their material properties. Six material models were used to fit the experimental data and the correlation between experimental and predicted data was evaluated for comparison. As a result, even if the tissues are of different nature, the best correlation was obtained with the Yeoh and Martins material models for all tissues. Moreover, these preliminary results show the difference in stiffness between the tissues which indicates that they might have different roles in the structure. These obtained results will serve as a basis to design an improved experimental protocol for a more robust structural model of the porcine perineum that can be used for the human perineum to predict perineal tears.

Updating of pelvimetry standards in modern obstetrics.

Clinical value of pelvimetry in modern obstetrics practices has never been established and normal values are set since the middle of the twentieth century. The aim of this study was to describe current dimensions of pelvis in a female French Caucasian population. A retrospective, bi-centric observational study was conducted from August 2013 to August 2019 in two French departments of Obstetrics. We included all Caucasian women who had a computed tomography pelvimetry during pregnancy. The primary outcome was the values of the obstetric transverse diameter, obstetric conjugate diameter and bispinous diameter. Five hundred and fifty-one CT pelvimetries were analyzed. The median Obstetric Transverse Diameter (OTD) was 12.41 cm and the 3rd percentile was 11 cm. The median Obstetric Conjugate Diameter (OCD) was 12.2 cm and the 3rd percentile was 10.5 cm. The median Bispinous Diameter (BSD) in our data collection was 10.9 cm and the 3rd percentile was 9.3 cm. A significant correlation coefficient between women's height and OTD, OCD and BSD was found. In our study, the OCD and the BSD have not evolved since the middle of the twentieth century. The obstetric transverse diameter was smaller than the standard currently used.

Mobility analysis of a posterior sacrospinous fixation using a finite element model of the pelvic system.

INTRODUCTION AND HYPOTHESIS: In order to improve the knowledge POP physiopathology and POP repair, a generic biomechanical model of the female pelvic system has been developed. In the literature, no study has currently evaluated apical prolapse repair by posterior sacrospinous ligament fixation using a generic model nor a patient-specific model that personalize the management of POP and predict surgical outcomes based on the patient's pre-operative Magnetic Resonance Imaging. The aim of our study was to analyze the influence of a right and/or left sacrospinous ligament fixation and the distance between the anchorage area and the ischial spine on the pelvic organ mobility using a generic and a patient-specific Finite Element model (FEM) of the female pelvic system during posterior sacrospinous ligament fixation (SSF). METHODS: Firstly, we used a generic 3D FEM of the female pelvic system previously made by our team that allowed us to simulate the mobility of the pelvic system. To create a patient-specific 3D FEM of the female pelvic system, we used a preoperative dynamic pelvic MRI of a 68 years old woman with a symptomatic stage III apical prolapse and cystocele. With these 2 models, a SSF was simulated. A right and/or left SSF and different distances between the anchorage area and the ischial spine (1 cm, 2 cm and 3 cm.) were compared. Outcomes measures were the pelvic organ displacement using the pubococcygeal line during maximal strain: Ba point for the most posterior and inferior aspect of the bladder base, C point the cervix's or the vaginal apex and Bp point for the anterior aspect of the anorectal junction. RESULTS: Overall, pelvic organ mobility decreased regardless of surgical technique and model. According to the generic model, C point was displaced by 14.1 mm and 11.5 mm, Ba point by 12.7 mm, and 12 mm and Bp point by 10.6 mm and 9.9 mm after left and bilateral posterior SSF, respectively. C point was displaced by 15.4 mm and 11.6 mm and Ba point by 12.5 mm and 13.1mm when the suture on the sacrospinous ligament was performed at 1 cm and 3 cm from the ischial spine respectively (bilateral posterior SSF configuration). According to the patient-specific model, the displacement of Ba point could not be analyzed because of a significative and asymmetric organ displacement of the bladder. C point was displaced by 4.74 mm and 2.12 mm, and Bp point by 5.30 mm and 3.24 mm after left and bilateral posterior SSF respectively. C point was displaced by 4.80 mm and 4.85 mm and Bp point by 5.35 mm and 5.38 mm when the suture on the left sacrospinous ligament was performed at 1 cm and 3 cm from the ischial spine, respectively. CONCLUSION: According to the generic model from our study, the apex appeared to be less mobile in bilateral SSF. The anchorage area on the sacrospinous ligament seems to have little effect on the pelvic organ mobilities. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04551859.

Enhanced Recovery after Pelvic Organ Prolapse Surgery.

The objective of this study was to review on the influence of enhanced rehabilitation in pelvic organ prolapse surgery outcomes, specifically focusing on length of hospital stay, hospital costs, pain, morbidity, and patient satisfaction. Following the PRISMA model and using PubMed as a source, eight articles pertaining to prolapse surgery and two articles concerning vaginal hysterectomies were selected, all published between 2014 and 2021. These studies revealed no significant difference in terms of operating time, intra- and post-operative complications, intra-operative blood loss and post-operative pain scores before and after the introduction of the ERAS program. Only one study noted a difference in readmission rates. There was, however, a noticeable decrease in intra-operative and post-operative intravenous intakes, opioid administration, length of stay, and overall hospital costs with the adoption of ERAS. Additionally, with ERAS, patients were able to mobilize more rapidly, and overall patient satisfaction significantly improved.

YouTube as a source of information on ectopic pregnancy: A qualitative and quantitative analysis.

OBJECTIVE: The aim of this study was to assess the quality and reliability of YouTube videos on ectopic pregnancies for the public. METHOD: We searched for the key terms "ectopic pregnancy", "ectopic birth" and "extra uterine pregnancy" on YouTube. Each video that met the inclusion criteria was analyzed by two independent raters. Quantitative and qualitative metrics were recorded, and the videos were scored using the DISCERN instrument. RESULTS: A total of 37 videos met the inclusion criteria. The mean overall DISCERN score was 44.5 ± 15.6. Videos had significantly a higher DISCERN score if they contained explanations on anatomy (pvalue <0.01), physiopathology (p-value <0.01), diagnosis (p-value = <0.01), treatments (p-value <0.01), symptoms (p-value <0.01), clear information (p-value <0.01), animations (p-value <0.01) and if it was a physician speaking (p-value <0.01). CONCLUSION: YouTube videos on ectopic pregnancy have been assessed to be only fairly reliable. We identified the five best ones using the validated DISCERN instrument. While ectopic pregnancy is not uncommon, YouTube videos should be improved to provide more accurate information for the public.

Influence of in utero fetal death on perineal tears in vaginal deliveries.

The aim of this work was to evaluate and compare the incidence of perineal tears and Obstetrical anal sphincter injuries (OASIS) after vaginal delivery following a in utero fetal death (IUFD) compared with those with a live-birth. We conducted a single-center, retrospective cohort study using a database of all women who underwent a spontaneous vaginal delivery in the level III maternity ward. Exclusion criteria were breech presentation, cesarean section birth, instrumental delivery, multiple pregnancy, delivery before 24 + 6 weeks of gestation (WG) and termination of pregnancy for medical reasons. Women from the database were divided into two groups: an "in utero fetal death" (IUFD) group and a control group. Women were included in the IUFD group if they had a spontaneous vaginal delivery following a fetal demise after 24 + 6 WG in cephalic presentation between January 2006 and June 2020. Women in the "control" group were selected from the same database and were included if they underwent a spontaneous vaginal delivery of a live fetus in cephalic presentation, after 24 + 6 WG, during the same period. Each woman in the "IUFD" group was matched to two women (ratio 1:2) in the control group for parity, maternal age, body mass index, gestation and birth weight. The primary outcome was the presence of a sutured or unsutured perineal tear. During the study period, 31,208 patients delivered at a level III maternity hospital. Among them, 215 and 430 women were included in the IUFD group and the control group respectively. The two groups were comparable for all demographic and clinical characteristics except for an epidural analgesia (92% versus 70% in the control group, p < 0.01) and labor induction (86% versus 17% in the control group, p < 0.01). The incidence of any perineal tears was 13% (28/15) in the IUFD group versus 16% (70/430) in the control group. Relative risk of any perineal tears was non significative (RR = 0.8 IC95% [0.5-1.2]). The incidence of first-degree perineal tears was 10% in the IUFD group and 11% in the control group. The incidence of second-degree perineal tears was 18% in the IUFD group and 28% in the control group. Relative risk of first-degree perineal tears (RR = 0.88 95% CI [0.5-1.4]) and second-degree tears (RR = 0.51 95% CI [0.2-1.4]) were non significative. No obstetrical anal sphincter injury was found in either group. Vaginal delivery following a fetal demise did not appear to be either a risk factor or a protective factor for perineal tears. But there as a trend toward a lower incidence of second degree perineal tears in this context.

The transvaginal mesh: an overview of indications and contraindications for its use.

INTRODUCTION: In recent decades, concerns about safety of synthetic non-absorbable materials transvaginally implanted emerged. We aim to define the actual role of synthetic non-absorbable transvaginal mesh (TVM) for pelvic organ prolapse (POP) and mid-urethral sling (MUS) for stress urinary incontinence (SUI), in relation with the worldwide legislative evolution. AREAS COVERED: While in the United Kingdom MUS is not considered the first-line surgical option, other countries adopt MUS as the main procedure. United States, United Kingdom, Australia, New Zealand, France banned or paused TVM use for POP repair. At the same time, Germany, Asian, and South American countries adopt TVM after adequate counseling for selected populations such as women affected by or at high risk of POP relapse and contraindication for other surgical routes. EXPERT OPINION: The worldwide evolution of recommendations determined deep modification of clinical practice, with native tissue repair returning to forefront when the vaginal route is indicated. A more careful evaluation of the safety and efficacy profile of meshes' materials and the assessment of the minimal surgeon's expertise in performing TVM procedures became crucial. A multidisciplinary approach and a high specialization of the hospitals both in performing mesh procedures and in managing complications are mandatory.

A comparison between the vaginal patch plastron associated with the anterior sacrospinous fixation and the Uphold™ LITE vaginal support system for the treatment of advanced anterior vaginal wall prolapse.

OBJECTIVE: The aim of the present study was to compare efficacy and safety of the vaginal patch plastron (VPP) associated to the anterior sacrospinous fixation (SSLF-A) with a TVM procedure (Uphold™ LITE support-system) for the treatment of the advanced anterior vaginal wall prolapse. STUDY DESIGN: Single-center retrospective study. Women with symptomatic anterior prolapse ≥ III stage according to the POP-quantification (POP-Q) system and submitted to the VPP associated with the SSLF-A or to the Uphold™ procedure were included. Primary outcome was to compare objective and subjective cystocele relapse and reoperation rate at 6- and 12-month follow-up. Secondary outcome was to describe peri- and postoperative complications. Pearson chi-square test and exact Fisher test were adopted for categorical variables, while intergroup Mann-Whitney U test and intragroup Wilcoxon Rank Sum Test for continuous variables; the statistical analysis was conducted at 95 % confidence level. RESULTS: Fifty-five women in VPP-group and 118 women in Uphold-group were included. At 6-month follow-up, objective anterior relapse in VPP-group (3/55, 5.4 %) was like Uphold-group (5/118, 4.2 %; p = 0.71), as well as objective apical relapse (0/55, 0 % vs 3/118, 2.5 %; p = 0.55); no significant difference emerged in bulge symptoms (1/55, 1.8 % vs 5/118, 4.2 %; p = 0.67). At 12-month follow-up women were telephonically investigated; no significant difference emerged in bulge symptoms (1/55, 1.8 % vs 6/118, 5.1 %; p = 0.43). Reoperation rate for the composite outcome POP relapse, stress urinary incontinence (SUI) and remotion of the TVM resulted lower in the VPP group (1/55, 1.8 % vs 13/118, 11 %; p = 0.03). Post-operative buttock pain (32/55, 58.2 % vs 24/118, 20.3 %; p < 0.0001) and post-operative urinary retention (16/55, 29.1 % vs 6/118, 5.1 %; p < 0.0001) were higher in VPP-group, with a complete resolution between 2 and 3 weeks after treatment. CONCLUSION: VPP associated with SSLF-A was as effective as Uphold™ LITE support-system for both anterior and central compartment prolapse treatment at 6- and 12-month follow-up. VPP-group presented a lower reoperation rate for the composite outcome prolapse relapse repair, SUI, and removal of the mesh.

Comparison of Early Postoperative Outcomes for Vaginal Anterior Sacrospinous Ligament Fixation with or without Transvaginal Mesh Insertion.

Pelvic organ prolapse affects one in three women, and cystocele accounts for 80% of the indications for surgery. Following the withdrawal of transvaginal mesh from the market, the objective of the present before-and-after study was to compare of the previous reference technique (UpholdTM (Boston Scientific, Marlborough, MA, USA) mesh insertion) with anterior sacrospinous ligament fixation with suturing in terms of the outcomes 2 months after surgery. We performed a retrospective, observational, before-and-after study at Lille University Medical Center (Lille, France) by including consecutive patients operated on between 2011 and 2018 for UpholdTM mesh insertion and between 2018 to 2020 for anterior sacrospinous ligament fixation. The primary outcome was the early recurrence of prolapse, and the secondary outcomes were the occurrence of early per-operative or post-operative complications and the development of de novo stress urinary incontinence. Here, 466 patients were included in the study (382 in the UpholdTM group and 84 in the anterior sacrospinous ligament fixation group). The failure rate at 2 months was 6.0% (5 out of 84) for anterior sacrospinous ligament fixation and 1.3% (5 out of 382) for UpholdTM (p < 0.01). The prevalence of acute urinary retention was significantly lower in the anterior sacrospinous ligament fixation group (3.6%) than in the UpholdTM group (14.1%; p < 0.01), as was the de novo stress urinary incontinence rate (11.9% vs. 33.8%, respectively; p < 0.01). Anterior sacrospinous ligament fixation appears to be an effective, safe alternative to mesh insertion in the management of cystocele via the vaginal approach; the early complication rate was slightly lower, but the early failure rate was slightly higher.