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Objective: Surgical introital reduction procedures are commonly performed for the treatment of vaginal laxity (VL), yet poorly studied. The aim of this study was to assess clinical outcomes following surgical vaginal introital reduction for VL., Methods: This was an ambidirectional cohort study conducted in a single urogynecology center. All sexually active women who had vaginal introital surgical reduction for VL between March 2015 and September 2020 were included in this study. VL was defined as a genital hiatus distance ≥4cm according to the POP-Q classification, associated with symptoms of laxity. The primary endpoint was sexual health assessed by the Pelvi-Perineal Surgery Sexuality Questionnaire (PPSSQ), while the secondary endpoints included postoperative pain, perioperative complications, rate of dyspareunia, patient satisfaction and success rate based on the Patient Global Improvement Index (PGI-I) and Vaginal Laxity Questionnaire (VLQ)., Results: Of the 27 patients sent the questionnaires, 23 sexually active patients returned the completed ones and were included in the study. Participants had a mean age and BMI of 41 years (range 24-74) and 21.3 (range 17.6-31.9) respectively. The most prevalent preoperative symptom was feeling of VL in 82.6% followed by bulging sensation in 47.8%. Preoperative dyspareunia was reported in 8/23 (34.8%). Surgical interventions involved perineorrhaphy with (n=14) or without (n=9) levator ani plication. The PPSSQ mean sexual health score was 86.7/100 (SD 5.8; range 16.7-93.3) and the mean discomfort and pain score was 27.5/100 (SD 26.0; range 0-80). Postoperative sexuality was reported to better, identical or worse in 16 (69.6%), 2 (8.7%) and 5 (21.7%) patients respectively. On PGI-I, patients reported feeling much better, better, slightly better and no change in 10 (43.5%), 5 (21.7%), 5 (21.7%) and 3 (13.0%) respectively. None of the women reported feeling worse. The overall post-operative complication rate was 3/23 (13.0%), including a perineal hematoma, and two cases of reoperation for narrow introitus. De novo dyspareunia was reported by 11/18 (61.1%) patients, occurring often or more in 4/18 (22.2%) patients, due to narrow introitus (n=2), enlarge introitus (n=1) and vaginal dryness (n=1)., Conclusion: Vaginal introital reduction surgery is a viable treatment option for symptoms of vaginal laxity after failure of conservative measures. However, patients should be made aware of the risk of de novo dyspareunia., (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

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 (± 200 g), 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%; RR 0.802 (0.157; 4.101); p = 0.31). 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., (© 2023. The Author(s).)

(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.

Women's preoperative perceptions of pelvic-floor disorders may differ from those of their physicians. Our objective was to specify women's hopes and fears before cystocele repair, and to compare them to those that surgeons anticipate. We performed a secondary qualitative analysis of data from the PROSPERE trial. Among the 265 women included, 98% reported at least one hope and 86% one fear before surgery. Sixteen surgeons also completed the free expectations-questionnaire as a typical patient would. Women's hopes covered seven themes, and women's fears eleven. Women's hopes were concerning prolapse repair (60%), improvement of urinary function (39%), capacity for physical activities (28%), sexual function (27%), well-being (25%), and end of pain or heaviness (19%). Women's fears were concerning prolapse relapse (38%), perioperative concerns (28%), urinary disorders (26%), pain (19%), sexual problems (10%), and physical impairment (6%). Surgeons anticipated typical hopes and fears which were very similar to those the majority of women reported. However, only 60% of the women reported prolapse repair as an expectation. Women's expectations appear reasonable and consistent with the scientific literature on the improvement and the risk of relapse or complication related to cystocele repair. Our analysis encourages surgeons to consider individual woman's expectations before pelvic-floor repair.

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.

Aims: The terminology of obstetric pelvic floor disorders should be defined and reported as part of a wider clinically oriented consensus., Methods: This Report combines the input of members of two International Organizations, the International Continence Society (ICS) and the International Urogynecological Association (IUGA). The process was supported by external referees. Appropriate clinical categories and a sub-classification were developed to give coding to definitions. An extensive process of 12 main rounds of internal and 2 rounds of external review was involved to exhaustively examine each definition, with decision-making by consensus., Results: A terminology report for obstetric pelvic floor disorders, encompassing 357 separate definitions, has been developed. It is clinically-based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it usable by different specialty groups and disciplines involved in the study and management of pregnancy, childbirth and female pelvic floor disorders. Clinical assessment, investigations, diagnosis, conservative and surgical treatments are major components. Illustrations have been included to supplement and clarify the text. Emerging concepts, in use in the literature and offering further research potential but requiring further validation, have been included as an Appendix. As with similar reports, interval (5-10 year) review is anticipated to maintain relevance of the document and ensure it remains as widely applicable as possible., Conclusion: A consensus-based Terminology Report for obstetric pelvic floor disorders has been produced to support clinical practice and research., (© 2022. The Author(s).)

The main aim of the study was to evaluate severe post-operative complications following deep endometriosis surgery in a tertiary referral centre. 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. 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 women operated on for infertility, 34.5% (n = 20/58) got pregnant following surgery with 30% of these spontaneously. 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 making an informed choice about their management., (© 2022. The Author(s).)

Introduction and Hypothesis: Anterior bilateral sacrospinous ligament fixation (ABSSLF) was first described in 2000 but only evaluated in a limited number of studies. However, due to the FDA's ban on transvaginal mesh, interest in this technique has re-emerged. The SSLF procedure is known for its inherent high risk for anterior compartment failure; hence, in our center we started performing a preemptive concomitant anterior repair with the intention to reduce such risk. The aim of this study was to review the feasibility and clinical outcomes of this innovative technique., Methods: We performed a retrospective cohort study of all the women who had an ABSSLF and a concomitant anterior native tissue repair between May 2019 and July 2020 in a tertiary hospital in France. Our primary endpoint was surgical feasibility, while as secondary endpoints we wanted to explore the perioperative morbidities and clinical outcomes associated with this technique., Results: A total of 50 women were operated on in the studied period. The median follow-up time was 10 [8.5] months. It was feasible to perform the combined ABSSLF and concomitant anterior native tissue repair in all cases. The most frequent perioperative complications reported were urinary tract infection (14%) and difficulty in resuming voiding (16%). Anatomical and functional results were improved. The rate of anterior compartment recurrence was 37%., Conclusions: ABSSLF with a concomitant anterior native tissue repair is feasible and relatively safe for treating anterior and apical pelvic prolapse. However, anterior compartment failure rate is still a limitation. Further larger studies with long-term anatomical and functional results comparing this technique to alternative transvaginal surgical approaches are needed., (© 2022. The International Urogynecological Association.)

(1) Background: There is wide variation in the reported prevalence rates for pelvic organ prolapse (POP). There is also wide variation in the rate at which surgical interventions for pelvic organ prolapse are performed, as well as the type of interventions undertaken. As part of the International Consultation on Incontinence (ICI), our committee was tasked to produce evidence-based pathways for the surgical management of POP, any associated stress urinary incontinence (SUI), and bowel dysfunction. (2) Methods: To enable us to generate such evidence, we undertook a thorough search for the POP surgery-related, English-language scientific literature published up to April 2021. (3) Results: The committee evaluated the literature and made recommendations based on the Oxford grading system. (4) Conclusions: This review serves to provide a summary of the 2021 ICI surgical management of an evidence-based prolapse pathway and outline the evidence used to inform this guidance.

Introduction and Hypothesis: 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., Methods: 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., Results: 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)., Conclusions: 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., (© 2022. The International Urogynecological Association.)

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.

Objective: To assess the incidence of serious complications and reoperations for recurrence after surgery for pelvic organ prolapse (POP) and compare the three most common types of repair., Design: Prospective cohort study using a registry., Setting: Nineteen French surgical centres., Population: A total of 2309 women participated between 2017 and 2019., Methods: A multivariate analysis including an inverse probability of treatment weighting approach was used to obtain three comparable groups., Main Outcome Measures: Serious complications and subsequent reoperations for POP recurrence., Results: The median follow-up time was 17.6 months. Surgeries were native tissue vaginal repairs (n = 504), transvaginal mesh placements (n = 692) and laparoscopic sacropexies with mesh (n = 1113). Serious complications occurred among 52 women (2.3%), and reoperation for POP recurrence was required for 32 women (1.4%). At 1 year the cumulative weighted incidence of serious complications was 1.8% for native tissue vaginal repair, 3.9% for transvaginal mesh and 2.2% for sacropexy, and the rates for reoperation for recurrence of POP were 1.5, 0.7 and 1.1%, respectively. Compared with native tissue vaginal repair, the risk of serious complications was higher in the transvaginal mesh group (weighted hazard ratio, wHR 3.84, 95% CI 2.43-6.08) and the sacropexy group (wHR 2.48, 95% CI 1.45-4.23), whereas the risk of reoperation for prolapse recurrence was lower in both the transvaginal mesh (wHR 0.22, 95% CI 0.13-0.39) and sacropexy (wHR 0.29, 95% CI 0.18-0.47) groups., Conclusions: Our results suggest that native tissue vaginal repairs have the lowest risk of serious complications but the highest risk of reoperation for recurrence. These results are useful for informing women and for shared decision making., Tweetable Abstract: Laparoscopic sacropexy had fewer serious complications than transvaginal mesh and fewer reoperations for recurrence than vaginal repair., (© 2021 John Wiley & Sons Ltd.)

Study Objective: To evaluate the safety and potential efficacy of a novel degradable polymer film (DPF) designed to act as a 7-day barrier to prevent intrauterine adhesions (IUAs) after hysteroscopic myomectomy., Design: A prospective single-arm, first-in-human clinical study., Setting: Multicenter study involving 6 centers in France, Belgium, and the Netherlands., Patients: Women aged 40 years or older with no plans to conceive who qualified for hysteroscopic myomectomy (at least 1 10-mm type 0, 1, or 2 myoma) and had a sounded length of the uterine cavity (fundus to exocervix) ranging between 6 cm and 9 cm were considered eligible for the study., Interventions: The DPF was inserted after hysteroscopic transcervical myoma resection. The women were followed up by a telephone call at 30 days and second-look hysteroscopy 4 to 8 weeks after the procedure., Measurements and Main Results: The chosen safety outcome measures were uterine perforation or cervical trauma at the time of the DPF insertion and unexpected fever, pain, or bleeding beyond 48 hours and up to 30 days after insertion, whereas the outcome measure for efficacy was the absence of IUAs on second-look hysteroscopy. A total of 23 women participated in the study. There were no incidents of uterine perforation or cervical trauma at the time of the DPF insertion. There were no reported adverse effects attributable to the DPF. On second-look hysteroscopy, 20 (87%) of the 23 women had no IUAs., Conclusion: The DPF is a novel, easy-to-apply, and acceptable device to prevent IUAs, with very promising initial safety and efficacy data., (Copyright © 2021 AAGL. Published by Elsevier Inc. All rights reserved.)

Objective: To compare the effectiveness and safety of laparoscopic sacropexy (LS) and transvaginal mesh (TVM) at 4 years., Design: Extended follow up of a randomised trial., Setting: Eleven centres., Population: Women with cystocele stage ≥2 (pelvic organ prolapse quantification [POP-Q], aged 45-75 years without previous prolapse surgery., Methods: Synthetic non-absorbable mesh placed in the vesicovaginal space and sutured to the promontory (LS) or maintained by arms through pelvic ligaments and/or muscles (TVM)., Main Outcome Measures: Functional outcomes (pelvic floor distress inventory [PFDI-20] as primary outcome); anatomical assessment (POP-Q), composite outcome of success; re-interventions for complications., Results: A total of 220 out of 262 randomised patients have been followed at 4 years. PFDI-20 significantly improved in both groups and was better (but below the minimal clinically important difference) after LS (mean difference -7.2 points; 95% CI -14.0 to -0.05; P = 0.029). The improvement in quality of life and the success rate (LS 70%, 61-81% versus TVM 71%, 62-81%; hazard ratio 0.92, 95% CI 0.55-1.54; P = 0.75) were similar. POP-Q measurements did not differ, except for point C (LS -57 mm versus TVM -48 mm, P = 0.0093). The grade III or higher complication rate was lower after LS (2%, 0-4.7%) than after TVM (8.7%, 3.4-13.7%; hazard ratio 4.6, 95% CI 1.007-21.0, P = 0.049))., Conclusions: Both techniques provided improvement and similar success rates. LS had a better benefit-harm balance with fewer re-interventions due to complications. TVM remains an option when LS is not feasible., Tweetable Abstract: At 4 years, Laparoscopic Sacropexy (LS) had a better benefit-harm balance with fewer re-interventions due to complications than Trans-Vaginal Mesh (TVM)., (© 2021 John Wiley & Sons Ltd.)

Introduction and Hypothesis: 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., Methods: 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., Results: 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., Conclusions: 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., (© 2021. The International Urogynecological Association.)

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., Competing Interests: R.dT. and B.F. are consultants for Boston Scientific. The other authors have declared that they have no conflicts of interest., (Copyright © 2021 American Urogynecologic Society. All rights reserved.)

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., (Copyright © 2020 AAGL. Published by Elsevier Inc. All rights reserved.)

Introduction and Hypothesis: 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., Methods: 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., Results: 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 mm 2 ; p = 0.15) or on Valsalva (1568.81 vs. 1542.98 mm 2 ; 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%., Conclusions: 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.

Introduction and Hypothesis: 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., Methods: 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., Results: 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., Conclusion: 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.

Background: We aimed at developing a core outcome and variables of interest set to investigate the effects of mediolateral episiotomy on Obstetric Anal Sphincter Injury (OASI) during and after operative delivery in nulliparous women in a large-scale one-year observational French study including 15,000 women (INSTRUMODA)., Methods: A list of outcomes and variables of interest was suggested to obstetricians participating in the INSTRUMODA study using online questionnaires divided into 7 categories: the woman's history and course of pregnancy, course of labor, modalities of operative delivery, episiotomy characteristics, immediate maternal morbidity, one-year maternal morbidity, immediate neonatal morbidity. We used a three-round DELPHI method to reach a consensus. In the first round, outcomes and variables considered as essential by 70% or more of obstetricians were included in the corpus whereas they were excluded when 70% rated them as "not important". In the second round, non-consensual outcomes and variables were reassessed and excluded or definitively included if considered as "not important" or essential by 50% or more of the obstetricians. During the first round, obstetricians were invited to suggest new outcomes and/or variables that were then assessed in the second and third round. We used the same method to develop a core outcome and variables of interest set in a population of women in the community recruited via an association of patients. At the end of the procedure the core outcome and variables of interest sets were merged to provide the final core outcome set for the INSTRUMODA study., Results: Fifty-three obstetricians and 16 women filled out questionnaires. After the 3 rounds of Delphi procedure in each population, 74 outcomes and variables were consensually reported by obstetricians and 92 by women in the community. By mixing these two consensual corpora we reported a final consensual list of 114 variables of interest and outcomes for both obstetricians and women., Conclusion: We established a core outcome and variables of interest set among obstetricians and women in the community to investigate the association between mediolateral episiotomy and OASI during operative delivery., Trial Registration: The INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 ( NCT04446780 ).

Introduction and Hypothesis: 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., Methods: 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., Results: 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 < 0.001), and prior POP surgery (p = 0.034) were protective factors for postoperative SUI., Conclusion: Preoperative SUI is the most important risk factor for postoperative SUI. However, given the higher risk of postoperative complications with concomitant MUS and the acceptable rate of de novo SUI rate without it, two-stage surgery seems preferable for patients with preoperative SUI.

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., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

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., (© 2020 Wiley Periodicals, Inc.)

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.

Introduction and Hypothesis: The aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh (TVM) or native tissue repair., Methods: Prospective, randomized, multicenter study conducted between April 2005 and December 2009 comparing anterior colporrhaphy with trans-obturator vaginal mesh (Pelvitex/Ugytex®, Sofradim, Trevoux, France) for the treatment of anterior vaginal wall prolapse. The primary endpoint was functional recurrence rate 5-8 years after surgery. Secondary endpoints consisted of anatomical results, mesh-related morbidity and patient satisfaction measured through validated questionnaires., Results: Of the 147 women originally included, 75 (51%) were successfully re-contacted a median of 7 years after the initial surgery. The primary outcome, subjective recurrence of prolapse, was similar between the TVM and the anterior colporrhaphy groups (31 vs 34% respectively). Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004). Mesh exposure occurred in 4 of the 39 patients (13%) during follow-up, 2 of which had a surgical reintervention. Reintervention for prolapse took place in 7 patients (9%)., Conclusion: Seven-year follow-up showed similar functional outcomes for mesh and native tissue repair in anterior vaginal wall prolapse. TVM did not reduce repeat surgery in the long term; it did, however, reduce anatomical recurrence. Mesh exposure rates were relatively high, but no difference in outcome of pain or dyspareunia was noted.

Introduction: The purpose of the study was to assess the frequency of late postoperative complications, surgical revisions and anatomical and functional outcomes > 1year 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 (19g/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., (Copyright © 2019. Published by Elsevier Masson SAS.)

Objective: 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., (© 2019 John Wiley & Sons, Ltd.)

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.

Objective: To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse., Design: Prospective longitudinal cohort study using a surgical registry., Setting: Thirteen public hospitals in France., Population: A cohort of 1873 women undergoing surgery between February 2017 and August 2018., Methods: Preliminary analysis of serious complications after a mean follow-up of 7 months (0-18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems., Main Outcome Measures: Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death., Results: Fifty-two women (2.8%, 95% CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh., Conclusions: Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors., Tweetable Abstract: Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh., (© 2019 Royal College of Obstetricians and Gynaecologists.)

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., (© 2019 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.)

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., (© 2019 Wiley Periodicals, Inc.)

Introduction: The objective of these clinical practice guidelines was to analyse all of the interventions during pregnancy and childbirth that might prevent obstetric anal sphincter injuries (OASIS) and postnatal pelvic floor symptoms., Material and Methods: These guidelines were developed in accordance with the methods prescribed by the French Health Authority (HAS)., Results: A prenatal clinical examination of the perineum is recommended for women with a history of Crohn's disease, OASIS, genital mutilation, or perianal lesions (professional consensus). Just after delivery, a perineal examination is recommended to check for OASIS (Grade B); if there is doubt about the diagnosis, a second opinion should be requested (Grade C). In case of OASIS, the injuries (including their severity) and the technique for their repair should be described in detail (Grade C). Perineal massage during pregnancy must be encouraged among women who want it (Grade B). No intervention conducted before the start of the active phase of the second stage of labour has been shown to be effective in reducing the risk of perineal injury. The crowning of the baby's head should be manually controlled and the posterior perineum manually supported to reduce the risk of OASIS (Grade C). The performance of an episiotomy during normal deliveries is not recommended to reduce the risk of OASIS (Grade A). In instrumental deliveries, episiotomy may be indicated to avoid OASIS (Grade C). When an episiotomy is performed, a mediolateral incision is recommended (Grade B). The indication for episiotomy should be explained to the woman, and she should consent before its performance. Advising women to have a caesarean delivery for primary prevention of postnatal urinary or anal incontinence is not recommended (Grade B). During pregnancy and again in the labour room, obstetrics professionals should focus on the woman's expectations and inform her about the modes of delivery., (Copyright © 2019 CNGOF. Published by Elsevier Masson SAS.. All rights reserved.)

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., (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)

Introduction and Hypothesis: 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., Methods: 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., Results: 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 (scores > 0) 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., Conclusions: 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.

Introduction 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.

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., Competing Interests: Competing interestsX.G., S.L., S.H., V.L, J.C., and C.P. declare no competing financial interests but the following competing non-financial interests: the authors (X.G., S.L., S.H., V.L, J.C., and C.P.), the University of Montpellier, CNRS, and the University Hospital of Nîmes applied for a patent in 2014 for the polymers and their applications in gynecology. The patent application number is WO201602061. Our patent application is currently being evaluated and expected to have a response by the end of 2020. Two of the authors (S.H. and X.G.) have developed a start-up based on the results of the current study, and one of the authors (S.L.) is currently employed in this new company. L.A, S.W., I.L., A.B., H.T., and R.DeT. declare no competing financial and non-financial interests.

Introduction: There has been an increasing need for the terminology for the conservative management of female pelvic floor dysfunction to be collated in a clinically-based consensus report., Methods: This report combines the input of members and elected nominees of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS), assisted at intervals by many external referees. An extensive process of nine rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). Before opening up for comments on the webpages of ICS and IUGA, five experts from physiotherapy, neurology, urology, urogynecology and nursing were invited to comment on the paper., Results: A terminology report for the conservative management of female pelvic floor dysfunction, encompassing over 200 separate definitions, has been developed. It is clinically-based with the most common symptoms, signs, assessments, diagnoses and treatments defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in female pelvic floor dysfunction. Ongoing review is not only anticipated but will be required to keep the document updated and as widely acceptable as possible., Conclusion: A consensus-based terminology report for the conservative management of female pelvic floor dysfunction has been produced aimed at being a significant aid to clinical practice and a stimulus for research., (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)

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 (19g/m 2 ): 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., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

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 <45° (odds ratio 5.46 [1.11-26.75], p=0.037). After multivariate analysis, this result was no longer significant (p=0.079)., Conclusion: It appears that many accoucheurs have difficulty estimating episiotomy incision angles correctly and that education and training in this domain requires improvement., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

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., (Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: The management of disposable and reusable supplies might have an impact on the cost efficiency of the Operating Room (OR). This study aimed to evaluate the cost and reasons for wasted supplies in the OR during surgical procedures., Methods: We conducted an observational and prospective study in a French university hospital. We assessed the cost of wasted supplies in the OR (defined by opened unused devices), the reasons for the wastage, and the circulator retrievals. At the end, we assessed the perception of surgeons and nurses relative to the supply wastage., Results: Fifty routine procedures and five non-scheduled procedures were observed in digestive (n = 20), urologic (n = 20) and gynecologic surgery (n = 15). The median cost [IQR] of open unused devices was €4.1 [0.5; 10.5] per procedure. Wasted supplies represented up to 20.1% of the total cost allocated to surgical supplies. Considering the 8000 surgical procedures performed in these three surgery departments, the potential annual cost savings were 100 000€. The most common reason of wastage was an anticipation of the surgeon's needs. The circulating nurse spent up to 26.3% of operative time outside of the OR, mainly attending to an additional demand from the surgeon (30%). Most of the survey respondents (68%) agreed that knowing supply prices would change their behavior., Conclusions: This study showed the OR is a major source of wasted hospital expenditure and an area wherein an intervention would have a significant impact. Reducing wasted supplies could improve the cost efficiency of the OR and also decrease its ecological impact., (Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.)

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 < 0.001). Similarly, in the subgroup of patients who underwent instrumental delivery, the rate of cPUR was lower in the intervention group (18%, 2/11) than in the observational group (65%, 15/23) (p = 0.02). Systematic intermittent bladder catheterization immediately postpartum could decrease cPUR. Further studies are necessary to assess the long-term outcomes and improve understanding of postpartum voiding dysfunction.