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Introduction Obstetric anal sphincter injuries (OASIs) at the time of childbirth can lead to serious consequences including anal incontinence, dyspareunia, pain and rectovaginal fistula. These types of lesions and their incidence have been well studied after cephalic presentation deliveries, but no publications have specifically addressed this issue in the context of vaginal breech delivery. The goal of our study was to evaluate the incidence of OASIs following breech deliveries and compare it with cephalic presentation births. Methods This was a retrospective cohort study involving 670 women. Of these, 224 and 446 had a vaginal birth of a fetus in the breech (breech group) and cephalic (cephalic group) presentations respectively. Both groups were matched for birthweight (± 200g), date of delivery (± 2 years) and vaginal parity. Main outcome of interest was to evaluate the incidence of OASIs following breech vaginal birth compared to cephalic vaginal births. Secondary endpoints were the incidence of intact perineum or first-degree tear, second-degree perineal tear and rates of episiotomies in each group. Results There was no statistically significant difference in OASIs incidence between the breech and cephalic groups (0.9% vs. 1.1%; OR 0.772 (0.133–4.479); p = 0.77). There were more episiotomies in the breech group (12.5% vs. 5.4%, p = 0.0012) and the rate of intact or first-degree perineum was similar in both groups (74.1% vs. 75.3%, p = 0.7291). A sub-analysis excluding patients with episiotomy and history of OASIs did not show any statistically significant difference either. Conclusion We did not demonstrate a significant difference in the incidence of obstetric anal sphincter injuries between women who had a breech vaginal birth compared to cephalic.

Study Objective To study the safety of a degradable polymeric film (DPF) and its efficacy on reducing the risk of intrauterine-adhesion (IUA) formation in a rat model. Design A series of case-control studies relying on random allocation, where feasible. Setting University and good practice animal laboratories. Animals The animal models comprised female and male Oncins France Strain A and female Wistar rats. Intervention(s) and Measurements The Oncins France Strain A rats were used for in vivo evaluation of the impact of the DPF on endometrial thickness and its effect on fertility. For in vivo evaluation of the biologic response, 40 Wistar rats were randomly allocated to intervention and control groups, with matched sampling time after surgery. Finally, for the in vivo evaluation of the DPF's efficacy on IUA prevention, a total of 24 Wistar rats were divided into 3 groups: 1 treated with the DPF, 1 treated with hyaluronic acid gel, and a sham group. Main Results The DPF did not have a significant impact on endometrial thickness, and there were no significant differences in the number of conceived or prematurely terminated pregnancies, confirming its noninferiority to no treatment. The DPF did not induce irritation at 5 days and 28 days. Finally, the DPF significantly reduced the likelihood of complete IUA formation compared with hyaluronic acid gel– and sham-implanted animals, where only 27% of the animals had their uterine cavity obliterated compared with 80% and 100%, respectively. Conclusion The DPF is a safe film that is effective in preventing IUA formation after intrauterine curettage in rats.

Objectives: The main aim of the study was to evaluate severe post-operative complications following deep endometriosis surgery in a tertiary referral centre.Methods: This is a retrospective cohort study that included women who had surgery for deep infiltrating endometriosis between 1st January 2013 and 31st December 2019. Endometriosis was diagnosed based on clinical, imaging and histological parameters. We evaluated the rates of post-operative complications, potential risk factors for such complications and postoperative pregnancy rates.Results: A total of 165 patients were included in the final analysis. The median follow-up was 63 (25 - 106) months. Thirty-seven patients (22.42%) had hysterectomy, 60 (36.81%) had ureterolysis and 44 (26.67%) had colorectal surgery. The overall and severe rates of post-operative complications were 16.20% (n=23) and 2.42% (n=4) respectively. Of the variables assessed, operative time and age were the only statistically significant risk factor for complications on multivariate analysis. Among the women operated on for infertility, 34.5% (n=20/58) got pregnant following surgery with 30% of these spontaneously.Conclusions: This study demonstrates acceptable overall and severe post-operative complications and pregnancy rates after deep endometriosis surgery. This information should help clinicians when counselling women to enable them make an informed choice about their management.

International audience; Objective: Pessary fitting and follow-up for women with pelvic organ prolapse (POP) can be performed by different health care practitioners (HCPs). We aimed to investigate knowledge and current practices among the main HCPs involved in pessary use in France. Materials and Methods: We sent an electronic questionnaire about pessary use to the members of eight French learned societies between April and October 2020. Results: During the study period, 1017 HCPs responded to the questionnaire: 712 (70.0%) were doctors, 208 (20.4%) physiotherapists, 95 (9.3%) midwives, and 7 (0.6%) nurses. Of the respondents, 69.1% claimed to be comfortable with pessary fitting and follow-up, and 54.1% think that a pessary can be offered as a first-line treatment in the management of POP. However, 60.1% reported that the main indications for pessaries were "older women," 71.3% for women with contraindications to surgery, and 60.5% for women waiting for surgery. 23.9% do not prescribe local estrogen therapy with a pessary for postmenopausal women. The main pessaries used are the ring and cube types (63.7 and 57.5%, respectively). Wide introitus (53.3%), difficulties of use (56.3%), a short vagina (41.4%), and major unmasked urinary incontinence (47.2%) are considered to be the main risk factors for pessary failure. The most common complications related to pessaries reported by the patients are vaginal discharge (48.6%) and pain or discomfort (40.6%). Up to 43.4% of respondents considered that a follow-up visit every 3-6 months was optimal. The need for training ranged from 42.8% for nurses to 65.2% for general practitioners. Conclusions: This national multidisciplinary survey revealed that HCPs in France are on the whole comfortable with pessaries and mainly prescribe the ring and cube form. Even if opinion about pessaries appears to be changing, HCPs would welcome additional training to improve knowledge and practices.

The aim of this study was to clinically validate the French-translated PISQ-IR in a French-speaking population of women with pelvic floor disorders. We aimed to recruit 300 women to account for potential attrition secondary to failure to respond or loss to follow-up. Women were enrolled as part of an RCT and from a separate specific study. Both studies included surgically managed patients. Data were collected at recruitment, visit 1 (V1), V2 (9–12 months postoperatively) and V3 (V2 + 5–15 days). Participants also completed a PFDI 20, ICI-Q and FSFI and were assessed by POP-Q. A total of 297 women were recruited between 18 January 2013 and 18 January 2016. Data were available for 291, 148 and 110 participants at V1, V2 and V3, respectively. The non-response rate for the NSA items varied from 5% to 30%, while for SA women, the non-response rate for the items varied from 0% to 15%. The tool was deemed reliable for five domains of the summary score. We also identified that several sections demonstrated acceptable to good temporal stability. A statistically significant score change was identified in different domains in the participants categorized as improved on either PGI-I or POP-Q. We also identified moderate to strong correlations between PISQ-IR and FSFI. The French translated PISQ-IR has several strengths in support of its validity. Our findings confirm the validity of the summary scores in addition to the item-based initial scoring system.

Objectives The aim of the study was to evaluate the effect of hysterectomy on the risk of complications from transvaginal pelvic organ prolapse surgery with mesh. Methods We conducted a retrospective cohort study between October 2010 and December 2017. Transvaginal mesh surgery was performed in patients with symptomatic anterior and/or apical prolapse (Pelvic Organ Prolapse Quantification ≥ stage 2). The primary outcome was rate of severe surgical complications based on the Clavien-Dindo classification (defined as grade ≥3), and the secondary outcome was the anatomical success at the last postoperative follow-up visit. Results Three hundred and ninety-six patients were included, 289 of these patients underwent anterior sacrospinous fixation with uterine preservation, 50 had a previous hysterectomy and 57 underwent a concomitant hysterectomy. The median follow-up was 12 months (interquartile range, 7 months). The rate of severe complications was 2.1%, 6.0%, and 5.3% in the uterine preservation group, previous hysterectomy group, and concomitant hysterectomy group, respectively (P = 0.2). The operative time was significantly higher in the concomitant hysterectomy group, and the mesh exposure rate was significantly higher in the previous hysterectomy group. The overall recurrence rate was 7.6%, with no differences between the study groups. Conclusions Concomitant and previous hysterectomy did not appear to increase the severe complication rate or anatomical failure after transvaginal mesh surgery. However, a history of hysterectomy appears to be a risk factor for vaginal mesh exposure. This must be considered in the choice between prosthetic and autologous management options for the treatment of posthysterectomy vault prolapse.

The use of new lightweight meshes in pelvic organ prolapse (POP) surgery may reduce complications related to mesh retraction (chronic pain, dyspareunia, and mesh exposure). The aim of this study was to investigate changes in the area and position of Uphold Lite™ mesh 6 weeks and 12 months after anterior and/or apical prolapse repair. This observational prospective multicenter study included patients who had undergone transvaginal surgery for symptomatic POP-Q stage ≥ II anterior and/or apical compartment prolapse with placement of Uphold Lite mesh. The dimensions and position of the mesh were evaluated at 6 weeks and 12 months by ultrasonography. Correlations between ultrasonographic mesh characteristics and POP recurrence were analyzed. Fifty evaluable women with an average age of 66.8 years were included. No statistically significant difference in mesh area was found between week 6 and month 12 postoperatively, either at rest (1746.92 vs. 1574.48 mm2; p = 0.15) or on Valsalva (1568.81 vs. 1542.98 mm2; p = 0.65). The ROC-AUC of the distance between the mesh and the bladder neck (M-BN) at 6 weeks for predicting cystocele recurrence at 12 months was 0.764 (95% CI 0.573–0.955) at rest and 0.724 (95% CI 0.533–0.916) on Valsalva. An M-BN distance > 12.5 mm could predict cystocele recurrence at month 12 with a sensitivity of 80% and a specificity of 69%. Ultrasonographic measurements of the Uphold Lite™ mesh appear to remain stable between 6 weeks and 12 months postoperatively. M-BN distance correlates with cystocele recurrence. These results appear to confirm the value of ultrasound in mesh evaluation.

The aim was to evaluate the reoperation rate and outcomes in women who underwent transvaginal non-absorbable monofilament polypropylene mesh placement for the treatment of cystocele. The retrospective cohort study included 63 patients who underwent transvaginal surgery using a synthetic polypropylene mesh (Gynemesh™) for cystocele. Patients were evaluated using a clinical examination (POP-Q) and validated questionnaires (PGI-I, PFDI-20, PFIQ-7) at 18 years of follow-up (median 18 years [IQR 16–19]). Cumulative death rate was 13 out of 63 (20%) and rate of total loss to follow-up was 21 out of 50 (42%). Finally, among the 63 women who underwent surgery, 29 completed maximum follow-up and 21 underwent a clinical examination. The cumulative reoperation rate was 35% (22 out of 63). Three patients were reoperated on because of recurrence of pelvic organ prolapse. Among the 63 patients initially operated, vaginal mesh exposure occurred in 16 (25%) during follow-up and 11 women (17%) needed a reintervention for vaginal mesh exposure. One patient was reoperated on for bladder mesh exposure. Among the 29 women who completed follow-up, the overall postoperative improvement rate was 93% after 18 years (PGI-I: 1–3). Mean overall satisfaction rate was 80 out of 100. Functional success rate was 76% (22 out of 29) and anatomical success rate was 62% (13 out of 21). The median score of the POP-DI-6 was 4.1 (IQR: 0–11) and the median score of the PFDI-20 was 30.7 (IQR: 13–60) in the 29 women who completed maximum follow-up. At very long-term follow-up, the recurrence rate of cystocele following polypropylene mesh placement by the vaginal route remained low and the satisfaction rate was high. However, we found high cumulative reoperation and mesh exposure rates.

Debate persists over whether surgery to correct pelvic organ prolapse (POP) should be combined with midurethral sling (MUS) insertion. The aim of this study was to evaluate the incidence of stress urinary incontinence (SUI) up to 12 months after transvaginal mesh surgery, with or without MUS, and to identify risk factors for postoperative SUI. This retrospective single-center study included patients who underwent transvaginal mesh surgery with Uphold™ between October 2010 and December 2017. The primary outcome was the prevalence of SUI at 12 months postoperatively. Univariate and multivariate logistic regression was used to identify risks factors for postoperative SUI. Of the 308 women included, 123 (40%) were continent (no SUI), 108 (35%) had SUI, and 76 (25%) had occult SUI. Forty-nine patients (15.9%) had a concomitant MUS procedure. At 12 months after surgery, 35.9% of patients without concomitant MUS had SUI vs 14.3% with (p = 0.003). Thirty-five patients (29%) developed de novo SUI. Postoperative complications were more common in patients with concomitant MUS (30.6% vs 17%; p = 0.003). The best predictor of postoperative SUI was the presence of preoperative SUI (OR 2.52 (1.25–5.09). Concomitant MUS (p

(1) Background: Pelvic organ prolapse (POP) can be managed using a vaginal pessary. However, the decision-making process whereby health professionals choose the right pessary is unclear. The objective of this study was to focus on the experience of experts in pessary use and to propose an algorithm. (2) Methods: A prospective study, based on face-to-face semi-directive interviews and group discussions, was conducted on a multidisciplinary panel of professional experts specialized in pessary prescriptions. A consensual algorithm was established, and its accuracy was assessed by expert and non-expert panels. The Consolidated Criteria for Reporting Qualitative Studies (COREQ) were used. (3) Results: 17 semi-directive interviews were conducted. The parameters involved in the decision-making process regarding the choice of vaginal pessaries were: desire for self-management (65%), associated urinary stress incontinence (47%), POP type (41%), and POP stage (29%). The algorithm was developed step by step (4 iterations) using the Delphi technique. Most of the expert panel (76%) rated the relevance of the algorithm as 7 or more out of 10 on a visual analog scale according to their own experience (reference activity). Finally, most (81%) of the non-expert panel (n = 230) rated the usefulness of this algorithm as 7 or more out of 10 on a visual analog scale. (4) Conclusions: This study provides an expert panel-based algorithm that may help in the prescription of pessaries for POP.

Objective: To evaluate the rates of serious complications and reoperation for recurrence following sacrospinous ligament fixation (SSLF) for apical pelvic organ prolapse. Methods: This was a national registry ancillary cohort comparative study. The VIGI-MESH registry includes data from 24 French health centers prospectively collected between May 2017 and September 2021. Time to occurrence of a serious complication or reoperation for genital prolapse recurrence was explored using the Kaplan–Meier curve and Log-rank test. The inverse probability of treatment weighting, based on propensity scores, was used to adjust for between-group differences. Results: A total of 1359 women were included and four surgical groups were analyzed: Anterior SSLF with mesh (n = 566), Anterior SSLF with native tissue (n = 331), Posterior SSLF with mesh (n = 57), and Posterior SSLF with native tissue (n = 405). Clavien–Dindo Grade III complications or higher were reported in 34 (2.5%) cases, with no statistically significant differences between the groups. Pelvic organ prolapse recurrence requiring re-operation was reported in 44 (3.2%) women, this was higher following posterior compared with anterior SSLF (p = 0.0034). Conclusions: According to this large database ancillary study, sacrospinous ligament fixation is an effective and safe surgical treatment for apical prolapse. The different surgical approaches (anterior/posterior and with/without mesh) have comparable safety profiles. However, the anterior approach and the use of mesh were associated with a lower risk of reoperation for recurrence compared with the posterior approach and the use of native tissue, respectively.

The main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and postoperative dyspareunia after both sacrocolpopexy/hysteropexy (SCP) and vaginal mesh surgery.A prospective, multicenter, randomized, open-label study with two parallel groups treated by either SCP or Uphold Lite vaginal mesh was carried out. Study participants were ≥ 50 and 80 years old patients with Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 who were considered eligible for reconstructive surgery and who were sexually active with no dyspareunia and free from bothersome SUI at presentation. Women were assessed before surgery and at 4-8 weeks and 11-13 months after using validated measures including POP-Q, Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), and Patient Global Impression of Improvement (PGI-I). Data were also collected for health economics evaluation.Of the required sample of 156 women, 42 women (19 SCP and 23 vaginal mesh) were only recruited owing to the discontinuation of vaginal mesh worldwide. The median follow-up was 376 days. The rates of bothersome de novo SUI were similar in the SCP and Uphold vaginal mesh groups (15.79 vs 15.00%, OR 0.95 [95% CI 0.22-4.14]). Among 30 sexually active patients at follow-up, the rates of women reporting de novo dyspareunia "usually or always" were 6.7% after SCP vs 13.3% after vaginal mesh (p = 1). Health economics evaluation showed a cost saving of 280€ in favor of the Uphold vaginal mesh technique, but no significant difference in the total cost (2,934.97€ for SCP vs 3,053.26€ for Uphold vaginal mesh).Bothersome de novo SUI and de novo dyspareunia occurred in approximately 15% and 23% of our study cohorts, with no significant difference between sacrocolpopexy/hysteropexy and anterior/apical vaginal mesh surgery. However, these results should be interpreted with caution owing to the small sample size.

International audience; Vaginal delivery is reported as a main risk factor of pelvic floor dysfunction. Nevertheless, data with a high level of evidence are lacking to confirm the hypothetic protective effect of pre-labor caesarean section. In order to promote a preventive strategy for a disease, it is necessary to know perfectly its pathophysiology and to be sure that the strategy is in place before the beginning of the pathological process. In other words, the causality between the exposure factor and the disease must be certain. Due to the maternal and neonatal morbidities associated with caesarean section it is essential to be careful before promoting prophylactic pre-labor caesarean section policies [1,2]. The objective of this scientific review is to provide a systematic analysis of the causality between vaginal delivery and pelvic floor dysfunction using Hill’s criterion for causality in order to devise a policy of advising pre-labor caesarean section to prevent pelvic floor dysfunction

International audience; Background: Good management of disposable and reusable supplies may improve surgical efficiency in the operating room (OR) and also corresponds to the best eco-responsible approach. The purpose of this study was to assess the impact of a clinical pharmacist's intervention in the OR on the non-compliant use of medical devices. We also assessed the economic impact of the pharmaceutical intervention.Materials and methods: We conducted a monocentric prospective study in the OR of a University hospital over one year. Three surgical specialties: urologic, digestive and gynecologic were audited after a preparatory phase to optimize usage of medical devices used for surgeries. The supply costs concerning the three specialties were compared before and after the pharmacist intervention.Results: One hundred and fifty surgical procedures were audited in digestive (33.3%, n = 50), gynecologic (32%, n = 48) and urologic (34.7%, n = 52) surgeries. With the pharmacist in OR, 51 procedures (34% CI95%[26.4%; 41.6%]) with a non-compliance concerning at least one medical device were found compared to the 50% rate without the pharmacist reported previously (P < .0001). Eighteen percent of surgical procedures had at least one circulator retrieval for the reason "incomplete case cart despite device listed on the case cart list" versus 29.1% before pharmacist intervention (P = .0028). A €33 014 saving associated with the presence of the pharmacist in OR was observed.Conclusions: This prospective interventional study showed that the intervention of a pharmacist specialized in the medical device field could significantly reduce non-compliances in medical device use and reduce costs in OR.

International audience; Polypropylene (PP) mesh has been used as a primary or adjuvant material for vaginal reconstruction for both stress urinary incontinence (SUI) and pelvic organ prolapse (POP) for decades. Whether polypropylene is the optimal material for such indications has been called into question by clinicians, regulatory agencies and the public in several countries around the world. This paper is a report of presentations and subsequent discussion at the annual International Consultation on Incontinence Research Society (ICI-RS) Meeting in June 2019 in Bristol, UK on the proposal "Is polypropylene mesh material fundamentally safe for use as a reconstructive material in vaginal surgery?" in which several of the salient issues were presented and discussed.

International audience; Sexual dysfunction is one of the symptoms associated with pelvic organ prolapse (POP) that motivates women to seek medical help. Women with POP are likely to restrict sexual activity owing to a perceived of loss of attractiveness and fear of incontinence. Conservative (pelvic floor muscles training or pessary) or surgical management (transabdominally or transvaginally) can be offered to treat POP but questions remain regarding sexual outcome. Despite the usual improvement in sexual function after surgery, a risk of de novo dyspareunia exists irrespective of the procedure used with slightly increased risk after transvaginal repair. Preoperative patient counselling, ideally with a cross-disciplinary approach is an important part of management of POP.

Background Vaginal mesh safety information is limited, especially concerning single incision techniques using ultra lightweight meshes for the treatment of anterior pelvic organ prolapse (POP). Objective To determine the intraoperative and postoperative complication rates after anterior POP repair involving an ultralight mesh (19 g/m2): Restorelle® Direct Fix™. Methods A case series of 218 consecutive patients, operated on between January 2013 and December 2016 in ten tertiary and secondary care centres, was retrospectively analyzed. Eligible patients had POP vaginal repair (recurrent or not) planned with anterior Restorelle® Direct Fix™ mesh (with or without posterior mesh). Surgical complications were graded using the Clavien-Dindo classification. Results Intraoperative complications were bladder wound (0.5%), rectal wound (0.5%), ureteral injuries (0.9%). 98.2% of the patient did not have per operative complications. We observed one fail of procedure. Early complications mainly included urinary retention (8.7%) urinary tract infections (5.5%) and haematoma (2.7%). One haematoma required surgical treatment and another, embolization. 80.7% of the patient did not have complications during hospitalization and 80.3% did not have complication at the follow up visit. None of the analyzed factors (age, body mass index, surgical history, grade of prolapse or concomitant procedure) was significantly associated with the risk of perioperative complications. A total of 2.8% patients had grade III complications according Clavien Dindo. None had grade IV or V. Conclusions This multicentre case-series on the early experience of the use of anterior Restorelle® Direct Fix™ mesh showed a satisfactory technical feasibility and a low rate of grade III complications according Clavien Dindo. Long term studies are necessary to assess anterior Restorelle® Direct Fix™ mesh performances and to appraise patient satisfaction feedback.

International audience; INTRODUCTION:The aim of this study was to evaluate episiotomy technique, in particular suture angles, and any correlation between suture angle and severe perineal tears.MATERIAL AND METHODS:An observational questionnaire-based study was conducted between 01 August 2015 and 30 April 2016 among accoucheurs performing episiotomies in a French maternity unit with facilities for high-risk pregnancies. For each patient included, accoucheurs were asked to measure the episiotomy suture angle, and to record the angle at which they thought they had cut, the length of the episiotomy, its distance from the anus, and whether the woman sustained a sphincter injury.RESULTS:The centre's episiotomy rate during the study period was 15%. We analyzed the characteristics of episiotomies performed on 89 women (68 by doctors and 21 by midwives). Only 43% of suture angles were between 45° and 60° (45.6% of those performed by doctors vs 38.1% by midwives, p=0.8623), whereas 91% of accoucheurs thought they had cut within the correct range. Doctors made longer incisions than midwives (4 [4.2-5.0] vs 3 [2.5-3.5] cm, p=0.0006). Only 40.5% of accoucheurs correctly estimated the incision angle. Twelve (13.64%) of the 88 women sustained a third-degree perineal tear. The risk of sphincter injury was higher with suture angles

Standardized terminology for surgical procedures commonly performed to treat stress urinary incontinence in women is needed to facilitate research, clinical care, and teaching in female pelvic medicine and reconstructive surgery.This report combines the input of members of the American Urogynecologic Society and the International Urogynecological Association, assisted by external referees. Extensive searches of the literature were performed, including Instructions for Use brochures and original source documents where possible. Historical context was considered along with procedural modifications, and expert opinion was included when appropriate.A terminology report for the procedures commonly performed to treat stress urinary incontinence in women was produced. Included procedures are midurethral sling, retropubic colposuspension, pubovaginal sling, urethral bulking, and artificial urinary sphincter. Appropriate figures have been included to supplement and help clarify the text. Ongoing review will be performed periodically to keep the document updated and widely acceptable.This document is a literature and consensus-based terminology report for surgical procedures to treat stress urinary incontinence in women. Future publications in female pelvic medicine and reconstructive surgery should use this standardized terminology whenever possible.

International audience; To evaluate fertility after robot-assisted laparoscopic myomectomy (RALM) in terms of pregnancy rates, and obstetrical outcomes.Patients: This is a retrospective cohort of RALM performed for symptomatic leiomyomas among women who want to conceive. Medical data were retrospectively reviewed. An office hysteroscopy was prescribed 3 months after the surgery.Results: Fifty-three patients were included. The mean number of myomas was 2 ± 1.5 with a mean size of 69 ± 17.7 mm. A breach of the cavity was noticed in 15.1% of the cases. Two cases of intrauterine adhesions were diagnosed and treated during the post-operative office hysteroscopy (5.7%). Clinical pregnancy rates were 52.8% with a live birth rate of 41.5% in patients desiring pregnancy. A caesarean section was performed in 17 cases (70.8%). No case of uterine rupture was reported.Conclusion: More than half of the patients became pregnant after RALM. A low rate of obstetrical complications was reported, with no uterine ruptures, highlighting the promise of this technique for infertile patients.

International audience; OBJECTIVE: The aim of this article is to summarize the relevant findings that inform the 2017 International Consultation on Incontinence pathway for surgical treatment of pelvic organ prolapse (POP). METHODS: We conducted an evidence-based review of the English-language peer-reviewed literature relating to POP surgery published prior to December 2016. Level 1 evidence (randomized controlled trials [RCTs] or systematic reviews of RCTs) was preferred; however, level 2 (poor-quality RCT, prospective cohort studies) or 3 evidence (case series or retrospective studies) has been included if level 1 data were lacking. The committee evaluated the literature and made recommendations based on the Oxford grading system summarized as follows: grade A recommendation usually depends on consistent level 1 evidence; grade B recommendation usually depends on consistent level 2 and/or 3 studies, or "majority evidence" from RCTs; grade C recommendation usually depends on level 3 studies or "majority evidence" from level 2/3 studies or Delphi-processed expert opinion; grade D, "no recommendation possible," would be used where the evidence is inadequate or conflicting. RESULTS: The recommendations from each chapter of the review are presented and serve to inform an evidence-based pathway for the surgical treatment of prolapse. A Web-based interactive application of the pathway is presented. CONCLUSIONS: The 2017 International Consultation on Incontinence pathway on surgery for POP is designed as an adjunct to transparent consultation and consent relating to POP surgery. The final decision regarding surgical intervention can be made only after a shared decision-making process between the patient and the clinician that will evaluate a variety of individual factors that cannot be assessed in the pathway.

Intrauterine adhesions lead to partial or complete obliteration of the uterine cavity and have life-changing consequences for women. The leading cause of adhesions is believed to be loss of stroma resulting from trauma to the endometrium after surgery. Adhesions are formed when lost stroma is replaced by fibrous tissue that join the uterine walls. Few effective intrauterine anti-adhesion barriers for gynecological surgery exist. We designed a degradable anti-adhesion medical device prototype to prevent adhesion formation and recurrence and restore uterine morphology. We focused on ideal degradation time for complete uterine re-epithelialization for optimal anti-adhesion effect and clinical usability. We developed a triblock copolymer prototype [poly(lactide) combined with high molecular mass poly(ethylene oxide)]. Comparative pre-clinical studies demonstrated in vivo anti-adhesion efficacy. Ease of introduction and optimal deployment in a human uterus confirmed clinical usability. This article provides preliminary data to develop an intrauterine medical device and conduct a clinical trial., Salome Leprince, Stephanie Huberlant et al. report the design of a degradable anti-adhesion intrauterine device that prevents formation of intrauterine adhesions following trauma or surgery. They show its efficacy in rats and its usability in the human uterus.

International audience; Aims: To identify differences in the vaginal microbiomes of women after transvaginal mesh (TVM) surgery for pelvic organ prolapse with and without mesh-associated complications.Methods: Patients with complications were eligible as cases, patients without as controls. DNA was isolated and the V1-2 region of the 16S ribosomal RNA gene was amplified and sequenced. Overall richness was quantified using Chao1. Overall diversity was expressed as Shannon diversity and screened for group differences using analysis of variance. Multivariate differences among groups were evaluated with functions from R.Results: We recruited 14 patients after mesh exposure, 5 after contraction, and 21 as controls. The average number of operational taxonomic unit was 74.79 (SD ± 63.91) for controls, 57.13 (SD ± 58.74) after exposures, and 92.42 (SD ± 50.01) after contractions. Total 89.6% of bacteria in controls, 86.4% in previous exposures, and 81.3% in contractions were classified as either Firmicutes, Proteobacteria, or Actinobacteria (P < .001). Veillonella spp. was more abundant in patients after contraction (P = .045). The individual microbiomes varied, and we did not detect any significant differences in richness but a trend towards higher diversity with complications.Conclusions: The presence of Veillonella spp. could be associated with mesh contraction. Our study did not identify vaginal microbiotic dysbiosis as a factor associated with exposure. Larger cohort studies would be needed to distinguish the vaginal microbiome of women predisposed to mesh-related complications for targeted phenotyping of patients who could benefit from TVM surgery.

International audience; ntroduction and hypothesis: Our purpose was to compare the prevalence of urinary incontinence (UI) 3 and 12 months after vaginal vs cesarean delivery of twins after 34 weeks of gestation.Methods: This was a multicenter prospective cohort study conducted at 172 French maternity units and included 2812 primiparous women with twins with no prior history of UI. Participants were enrolled at the time of delivery and followed up to 12 months postpartum. The primary outcome was the prevalence of UI, both stress and urge, 3 months postpartum, based on the patient reporting any frequency of urine leakage to the first question of the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). The Pelvic Floor Distress Inventory - Short Form 20 (PFDI-20), Pelvic Floor Impact Questionnaire - Short Form 7 (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Medical Outcome Study Short Form-12 (SF-12) were also used.Results: The ICIQ-SF was completed by 1155 (39.8%) and 800 (27.5%) women, respectively, at 3 and 12 months postpartum; 556 (48%) had delivered vaginally and 599 (52%) by cesarean section. The prevalence of UI at 3 months was 26% overall and was significantly higher in the vaginal delivery group at both 3 months (35% vs 17% in the cesarean group, p < 0.0001) and 12 months postpartum (38% vs 24%, p < 0.0001). UI was predominantly stress or mixed. The risk factors for UI at 3 months, determined by multivariate modeling, were vaginal delivery [odds ratio (OR) 3.073, 95% confidence interval (CI) 2.3-4.105, p < 0.0001) and body mass index >25 in early pregnancy (OR 1.620, 95% CI 1.188-2.209, p = 0.0023).Conclusions: Vaginal delivery is a risk factor for UI at 3 months after twin birth.

To compare the impact of vaginal delivery (VD) versus cesarean section (CS) on the pelvic floor in twin primiparae at 3 and 12 months postpartum.This comparative multicenter prospective cohort from a large French national cohort study consisted of primiparas who gave birth to live twins after 34 weeks of gestation. The primary end point was the postnatal urinary incontinence rate 3 months postpartum. The secondary end points were the pelvic floor dysfunction (PFD) at 3 and 12 months based on PFDI-20, PFIQ-7, PISQ-12, and SF-12 responses.A total of 2812 patients in 172 French maternity units were recruited between February 2014 and March 2015: 1076 (38%) responded at 3 and 12 months (61% at 3 months); 1155 were analyzed at 3 months (556 VD and 599 CS) and 800 at 12 months (394 VD and 406 CS). VD was associated with more symptoms at 3 months [median PFDI-20 score 25/300 (8-50) vs. 17/300 (4-36) after CS; p 0.0001]. Vaginal bulge was more frequently reported after VD (9 vs. 4%; p = 0.0015). Abdnormal PFD-related quality-of-life scores (scores0) were more frequent after VD at 3 months (58 vs. 42%; p 0.0001) and 12 months (57 vs. 43%; p = 0.0020), indicating greater discomfort. However, SF-12 scores were higher after VD [56 (53-59) vs. 55 (51-58)] at 12 months, indicating better general quality of life.Mode of delivery is significantly associated with pelvic organ prolapse symptoms 3 months postpartum, which regress by 12 months, probably because of the known spontaneous postnatal improvement of PFDs.

International audience; Aims: To evaluate the safety and efficacy of the Uphold LITE mesh in the treatment of pelvic organ prolapse at 12-month follow-up.Methods: Women undergoing a mesh surgery due to an anterior prolapse plus a symptomatic anterior prolapse (classed as pelvic organ prolapse quantification stage ≥2) were included in this prospective, multicentre, observational study. The primary endpoint was a composite outcome including a good anatomical correction, no prolapse symptoms, and no reintervention for an anterior or apical recurrent prolapse within 12 months of surgery. Secondary outcomes included safety, improvements in quality of life (QoL), and risk factor for recurrence. This study was registered with ClinicalTrials.gov, number NCT01559168.Results: A total of 121 patients were included. Symptomatic and anatomic cure rates were 94% (95 of 101) and 76.8% (76 of 99), respectively. The composite success rate was 72.4% (71 of 98). The rate of reoperation for apical or anterior recurrent prolapse was 3.9% (4 of 103). Anatomical anterior or apical recurrence occurred in 18.2% (18 of 97) and 7.2% (7 of 97) of patients, respectively. The composite success rate was significantly higher in centres where more than 30 patients had been treated (80% vs 50%; P = .045). The rate of serious complication was 5.4% (6 of 111). Improvements were recorded in QoL including sexual function.Conclusions: The Uphold LITE mesh procedure provides satisfactory outcomes in the treatment of anterior and apical prolapse, particularly in high-volume centres. The rates of adverse effects and reintervention for recurrent prolapse were acceptable.

International audience; Objective To assess morbidity and mortality following pelvic organ prolapse surgery in France, irrespective of the surgical technique, using a broad national database. Materials and methods: This descriptive multicenter retrospective study was conducted using a database populated via an application run by a professional association. Results 286 gynecologists contributed data to the database. Of the 4322 surgeries analyzed, an abdominal approach was used in 975 of cases (22.5%), a vaginal approach in 3277 (75.9%), and a combined approach in 68 (1.6%). After one year, abdominal surgery was associated with higher rates of de novo urinary incontinence, constipation, and intestinal obstruction, whereas vaginal surgery was associated with higher rates of urinary retention, hematoma, de novo chronic pain, and vaginal mesh extrusion. There was no significant difference between the groups in the incidence of severe complications. After one year, vaginal mesh-augmented cystocele repair was associated with higher rates of de novo urinary incontinence, de novo chronic pain, and reoperation than native tissue repair. Mesh repair was also associated with higher rates of severe complications at one year. Conclusion After pelvic organ prolapse surgery, the perioperative morbidity and mortality associated with transabdominal and transvaginal approaches are similar. However, transvaginal mesh repair is associated with greater perioperative morbidity than transvaginal native tissue repair.

Aims: The Female pelvic floor questionnaire (FPFQ) is a self-administered tool on pelvic floor function. Our aim was to carry out a cultural adaptation of the FPFQ into French and to assess its psychometric properties. Methods: After cross-cultural adaptation into French, acceptability and reliability of the questionnaire were assessed through a sample of 56 women in a test-retest. Discriminative construct validity was evaluated by comparing the results obtained by the FPFQ to those of other validated questionnaires. Longitudinal follow-up of the 282 pregnant women included in the PreNatal Pelvic floor Prevention trial (3PN) was used to analyze responsiveness. Results: The proportion of missing data did not exceed 4% for questions about bladder function, bowel function and pelvic organ prolapse; 10% for issues related to sexual function. Question 9 was considered difficult to understand by 14% of women. After rewriting, this issue was retested in a new sample of 52 women and presented no further problems. The intra-class correlation coefficient was greater than or equal to 0.7 for all domains during the test-retest. The FPFQ was strongly and significantly correlated (Spearman r>0.5) with the other validated questionnaires. The French version of FPFQ recorded changes in urinary and sexual symptoms for the women involved in 3PN trial with a standardized response mean equal to 0.83 and 0.44, respectively. Conclusion: The French version of the FPFQ is self-administered, reliable, valid, and can detect a change in symptoms during follow-up.

To compare, in an unselected population of nulliparous pregnant women, the postnatal effect of prenatal supervised pelvic floor muscle training with written instructions on postpartum urinary incontinence (UI).In a randomized controlled trial in two parallel groups, 282 women were recruited from five university teaching hospitals in France and randomized during the second trimester of pregnancy. The physiotherapy group received prenatal individually supervised exercises. Both groups received written instructions about how to perform exercises at home. Women were blindly assessed at baseline, end of pregnancy, and 2 and 12 months postpartum. The primary outcome measured was UI severity, assessed with an International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score (range 0-21; 1-5 is slight UI) at 12 months postpartum; other outcomes were UI prevalence and pelvic floor troubles assessed using self-administered questionnaires. To give a 1-point difference in UI severity score, we needed 91 women in each group (standard deviation 2.4, α=0.05, β=0.20, and bilateral analysis).Between February 2008 and June 2010, 140 women were randomized in the physiotherapy group and 142 in the control group. No difference was observed between the two groups in UI severity, prevalence, or pelvic floor troubles at baseline, end of pregnancy, and at 2 and 12 months postpartum. At 12 months postpartum, the primary outcome was available for 190 women (67.4%); mean UI severity was 1.9 in the physiotherapy group compared with 2.1 in the control group (P=.38).Prenatal supervised pelvic floor training was not superior to written instructions in reducing postnatal UI.ClinicalTrials.gov; www.clinicaltrials.gov, NCT00551551.I.

Background Laparoscopic mesh sacropexy (LS) or transvaginal mesh repair (TVM) are surgical techniques used to treat cystoceles. Health authorities have highlighted the need for comparative studies to evaluate the safety of surgeries with meshes. Objective To compare the rate of complications, and functional and anatomical outcomes between LS and TVM. Design, setting, and participants Multicenter randomized controlled trial from October 2012 to April 2014 in 11 French public hospitals. Women with cystocele stage ≥2 (pelvic organ prolapse quantification), aged 45–75 yr, without previous prolapse surgery. Intervention Synthetic nonabsorbable mesh placed in the vesicovaginal space, sutured to the promontory (LS) or maintained by arms through pelvic ligaments (TVM). Outcome measurements and statistical analysis Rate of surgical complications ≥grade II according to the modified Clavien–Dindo classification at 1 yr. Secondary outcomes were reintervention rate, and functional and anatomical results. Results and limitations A total of 130 women were randomized in LS and 132 in TVM; five women withdrew before intervention, leaving 129 in LS and 128 in TVM. The rate of complications ≥grade II was lower after LS than after TVM, but did not meet statistical significance (17% vs 26%, treatment difference 8.6% [95% confidence interval, CI −1.5 to 18]; p =0.088). The rate of complications of grade III or higher was nonetheless significantly lower after LS (LS=0.8%, TVM=9.4%, treatment difference 8.6% [95% CI 3.4%; 15%]; p =0.001). LS was converted to TVM in 6.3%. The total reoperation rate was lower after LS but did not meet statistical significance (LS=4.7%, TVM=10.9%, treatment difference 6.3% [95% CI −0.4 to 13.3]; p =0.060). There was no difference in symptoms, quality of life, improvement, composite definition of success, anatomical results rates between groups except for the vaginal apex and length, and dyspareunia (in favor of LS). Conclusions LS is a valuable option for primary repair of cystocele in sexually active patients. LS is safer than TVM, but may not be feasible in all cases. Both techniques offer same functional outcomes, success rates, and anatomical outcomes, but sexual function is better preserved by LS. Patient summary Our study demonstrates that laparoscopic sacropexy (LS) is a valuable option for primary repair of cystocele. LS offers equivalent success rates to vaginal mesh procedures, but is safer with a lower rate of complications and reoperations, and sexual function is better preserved.

We investigated whether implementation of a routine catheterization procedure in labor improves covert postpartum urinary retention (cPUR) rates. We conducted a prospective before-after study. 121 women admitted to delivery room in the observational group, and 82 in the intervention group, in a tertiary university hospital in Southern France were included. All patients in the intervention group were systematically catheterized 2 hours after delivery. cPUR was screened for in both groups. The primary end-point was cPUR (post-void residual bladder volume >150 ml when voided volume is >150 mL). The rate of cPUR decreased from 50% (60 out of 121 patients) in the observational group to 17% (14/82) in the intervention group (OR = 0.21; 95% Confidence Interval [0.13;0.58]; p

International audience; INTRODUCTION AND HYPOTHESIS:The use of mesh in pelvic organ prolapse (POP) surgery has become a widespread treatment option, but carries a risk of specific complications. The objective was to report the rate and type of reoperation for mesh-related complications after pelvic organ prolapse surgery in an urogynecological referral center over a period of 8 years.METHODS:A retrospective study was carried out including all patients operated for a mesh complication after prolapse surgery between September 2006 and September 2014 in the urogynecology unit in Nîmes hospital.RESULTS:Sixty-nine mesh complications were recorded among the 67 patients included. Surgical treatment of mesh-related complications accounted for 7% of all pelvic surgeries performed in our center. Thirty-two patients (47.8%) were referred from other centers and 35 patients (52.2%) were initially operated in our unit. The global rate of reintervention for mesh-related complications after prolapse repair performed in our unit was 2.8%. Of 69 mesh complications, 48 patients (71.6%) had transvaginal mesh (TVM) and 19 patients (28.4%) sacrocolpopexy (SCP). The indication for surgery was a symptomatic or large vaginal erosion (47.8%), symptomatic mesh contraction (20.3%), and infection (11.6%). The most frequent primary symptom was pelvic/perineal pain or dyspareunia (33.3% of cases). The mean time between initial mesh surgery and the reoperation for a complication was 33.4 months (95% CI, 24.5 to 42.2). Eleven patients (15.9%) required several interventions. In total, 77.9% of patients experienced complete recovery of symptoms after surgical management.CONCLUSION:In a referral center the global rate of reinterventions for mesh-related complications after POP repair is 2.8%. The surgical treatment of mesh complications appears to be a safe and effective procedure with cure of the symptoms in most cases.

Introduction The purpose of the study was to assess the frequency of late postoperative complications, surgical revisions and anatomical and functional outcomes > 1 year after the insertion of an ultra-light vaginal mesh for the treatment of genital prolapse. Material and methods In our multicenter retrospective series, patients who had a previous ultra-light transobturator mesh (19 g/m2) Restorelle®DirectFix™ mesh placed, either reviewed in post-operative consultation or interviewed by phone with a minimum of twelve months' follow-up were included. Results 172 patients were included in the analysis. Among them, 8/141 (5.7%) had chronic pain, 7/141 (5.0%) recurrent urinary tract infections, 1/70 (1.4%) resolving granulomas, 2/70 (2.9%) painful retractions, 2/70 (2.9%) colpectomy for vaginal erosion, 1/141 (0.7%) ureteral reimplantation, 1/141 (0.7%) a reoperation for colonic occlusion on mesh and 1/141 (0.7%) self urinary catheterization, 9% of patients with at least one minor complication (without major complication) and 3% of patients with a major +/- minor complication. Nine patients out of 142 (6.3%) had a surgical revision for recurrence of prolapse and 2/70 (2.9%) for vaginal mesh exposure. The anatomical success rate of cystocele repair was 72%. 20% of patients had symptomatic recurrence. The rate of de novo dyspareunia was 13%. Functional success was noted in 82% of patients. Conclusion The Restorelle® mesh has good safety and efficiency in the medium term. Long-term data and comparative studies are needed.

The sexual impact of urinary incontinence in women depends on a host of parameters, including physical, psychological, social and cultural dimensions. Evaluation of the effects of stress urinary incontinence (SUI) and lower urinary tract symptoms on sexual function is often biased by their common association with other pelvic floor disorders, such as pelvic organ prolapse, which also affect sexual satisfaction. Indeed, these complexities are reflected in the literature, which shows considerable disparity in sexual functional characteristics in women with incontinence both before and after treatment. This discordance is further emphasized by heterogeneity in study design, quality and analysis. Here, we describe the nature of sexual dysfunction in women with incontinence, including coital incontinence. The various treatments for SUI, which include transvaginal tape surgeries, can also affect sexual function, positively or negatively. Coital incontinence seems to be a good predictor of an improvement in postoperative sexual parameters: its cure, achieved by >90% of women, to a large extent explains the sexual benefits reported in several studies. By contrast, deterioration in sexual function is sometimes reported after surgery, with de novo or worsened dyspareunia being the most common cause. The literature does not contain any convincing arguments for one treatment or another on the basis of sexual functional outcome.