Serious complications and recurrences after retropubic vs transobturator midurethral sling procedures for 2682 patients in the VIGI-MESH register.

BACKGROUND: Midurethral slings are the gold standard for treating stress urinary incontinence, but their complications may raise concerns. Complications may differ by the approach used to place them. OBJECTIVE: This study aimed to compare serious complications and reoperations for recurrence after midurethral sling procedures when using the retropubic vs the transobturator route for female stress urinary incontinence. STUDY DESIGN: This analysis was of patients included in the French, multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence either by the retropubic or the transobturator route and excluded patients with single-incision slings. Follow-up continued until October 2021. Serious complications (Clavien-Dindo classification ≥ grade III) attributable to the midurethral sling and reoperations for recurrence were compared using Cox proportional hazard models including any associated surgery (hysterectomy or prolapse) and a frailty term to consider the center effect. Baseline differences were balanced by propensity score weighting. Analyses using the propensity score and Cox models were adjusted for baseline differences, center effect, and associated surgery. RESULTS: A total of 1830 participants received a retropubic sling and 852 received a transobturator sling in 27 French centers that were placed by 167 surgeons. The cumulative 2-year estimate of serious complications was 5.8% (95% confidence interval, 4.8-7.0) in the retropubic group and 2.9% (95% confidence interval, 1.9-4.3) in the transobturator group, that is, after adjustment, half of the retropubic group was affected (adjusted hazard ratio, 0.41; 95% confidence interval, 0.3-0.6). The cumulative 2-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% confidence interval, 2.0-3.6) in the retropubic group and 2.8% (95% confidence interval, 1.7-4.2) in the transobturator group with risk for revision for recurrence being higher in the transobturator group after adjustment (adjusted hazard ratio, 1.9; 95% confidence interval, 1.2-2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence. CONCLUSION: The transobturator route for midurethral sling placement is associated with a lower risk for serious complications but a higher risk for surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring.

Perceived health status after mid-urethral sling revision in 287 women from the VIGI-MESH registry: A cross-sectional study.

OBJECTIVE: To evaluate the health status and recovery of women after mid-urethral sling (MUS) revision in response to complications. DESIGN: Cross-sectional study using a questionnaire sent to women from a registry. SETTING: Twenty-two French surgical centres. POPULATION: A total of 287 women from the VIGI-MESH registry responded, having undergone MUS revision for complications. METHODS: Our sample of women were compared against a representative set of French women taken from the Eurostat database. Multivariate analysis was performed to identify clinical predictors for successful MUS revision. A qualitative analysis was carried out on free-text comments. MAIN OUTCOME MEASURES: Health status, defined by the Minimum European Health Module, and recovery, assessed by Patient Global Impression of Improvement. RESULTS: The response rate was 76% (287/378), with 49% of the women (141/287, 95% CI 43%-55%) reporting good health status, which was 8 points lower than that expected from the comparator French set (57%, 95% CI 55%-58%). Overall, 53% (147/275, 95% CI 47%-59%) of the women reported feeling much better after MUS revision. Just over one-third (35%, 95/275, 95% CI 29%-40%) of respondents reported poor health with little or no improvement. Multivariate analysis showed that being operated on for pain at revision was associated with worse self-perceived health than being operated on for exposure (OR 0.6, 95% CI 0.14-0.95); women with pre-existing comorbidity reported a poorer health status following MUS revision (OR 0.22, 95% CI 0.13-0.38). CONCLUSIONS: Our results suggest that half of the women recovered good health status after MUS revision, whereas a proportion appeared to be seriously affected by an MUS complication despite the revision.

Vaginal Hysterectomy and Pelvic Organ Prolapse: History and Recent Developments.

INTRODUCTION AND HYPOTHESIS: Vaginal hysterectomy (VH) was described as far back as 120 CE. However, it was not till the mid-1900s when reconstructive procedures were introduced to mitigate the risk of, or treat, pelvic organ prolapse in relation to VH. Furthermore, routine hysterectomy, particularly VH, has long been advocated in prolapse surgery. However, this indication is now questionable. METHODS: Literature review to provide an overview of current evidence and experts' opinion regarding the relationship between VH and pelvic organ prolapse. The review presents a historical perspective on the role of VH in the management of pelvic organ prolapse, the current debate on the usefulness of the procedure in this context, a practical guide on operative techniques used during VH and the impact of recent surgical developments on its use. RESULTS: Vaginal hysterectomy is a well-established technique that is still superior to laparoscopic hysterectomy for benign gynecological disease, although more surgically challenging. However, it is possible that some contemporary techniques, such as vaginal natural orifice transluminal endoscopic surgery, may overcome some of these challenges, and hence increase the number of hysterectomies performed via the vaginal route. Although patients should be counselled about uterine-sparing reconstructive surgery, vaginal hysterectomy continues to be a major surgical procedure in reconstructive pelvic floor surgery. CONCLUSIONS: Therefore, it is prudent to continue to train residents in vaginal surgical skills to ensure that they continue to provide safe, cost-effective, and comprehensive patient care.

Episiotomy practice in France and prevention of high-grade perineal tears at the time of operative vaginal delivery: a prospective multicentre ancillary cohort study.

INTRODUCTION AND HYPOTHESIS: Evidence suggests that episiotomies reduce the risk for obstetric anal sphincter injuries (OASIs) in operative vaginal deliveries (OVDs). However, there is limited evidence on the importance of episiotomy technique in this context. The primary objective of this study was to assess if an episiotomy suture angle >45° from the median line would be associated with a lower risk for OASIs at the time of OVD. METHODS: This was an ancillary study from the multicentre prospective cohort INSTRUMODA study. Of the 2,620 patients who had an OVD with a concomitant episiotomy between April 2021 and March 2022, a total of 219 fulfilled the inclusion criteria. Post-suturing photographs were used to assess episiotomy characteristics. RESULTS: Based on suture angles of ≤45° and >45° the study cohort was categorized into groups A (n = 155) and B (n = 64) respectively. The groups had comparable demographic and birth-related characteristics. The mean episiotomy length was significantly longer in group A than in group B (3.21 cm vs 2.84 cm; p = 0.009). Senior obstetricians performed more acute angled episiotomies than junior residents (p = 0.016). The total prevalence of OASIS was 2.3%, with no significant difference in rate of OASI between the two study groups. Birthweight was significantly higher in OASI births (p = 0.018) and spatula-assisted births were associated with higher risk for OASIs than ventouse or forceps (p = 0.0039). CONCLUSIONS: This study did not demonstrate a significant reduction in risk for OASI at the time of OVD when the episiotomy suture angle was >45° from the median line. However, these results should be interpreted with caution owing to the low prevalence of OASIs in our cohort.

Exploring risk factors of pelvic organ prolapse at eastern of Democratic Republic of Congo: a case-control study.

BACKGROUND: Pelvic organ prolapse is a common debilitating condition worldwide. Despite surgical treatment, its recurrence can reach up to 30%. It has multiple risk factors, some of which are particular for a low-resource settings. The identification these factors would help to devise risk models allowing the development of prevention policies. The objective of this study was to explore risk factors for pelvic organ prolapse in a population in eastern Democratic Republic of Congo (DRC). METHODS: This was an unmatched case-control study conducted between January 2021 and January 2022. The sample size was estimated to be a total of 434 women (217 with prolapse as cases and 217 without prolapse as controls). Data comparisons were made using the Chi-Square and Student T tests. Binary and multivariate logistic regressions were used to determine associated factors. A p < 0.05 was considered significant. RESULTS: Variables identified as definitive predictors of pelvic organ prolapse included low BMI (aOR 2.991; CI 1.419-6.307; p = 0.004), home birth (aOR 6.102; CI 3.526-10.561; p < 0.001), family history of POP (aOR 2.085; CI 1.107-3.924; p = 0.023), history of birth without an episiotomy (aOR 3.504; CI 2.031-6.048; p = 0), height ≤ 150 cm (aOR 5.328; CI 2.942-9.648; p < 0.001) and history of giving birth to a macrosomic baby (aOR 1.929; IC 1.121-3.321; p = 0.018). CONCLUSIONS: This study identified that Body Mass Index and birth-related factors are definitive predictors of pelvic organ prolapse in a low-resource setting. These factors are potentially modifiable and should be targeted in any future pelvic organ prolapse prevention policy. Additionally, there seems to be a genetic predisposition for prolapse, which warrants further assessment in specifically designed large scale studies.

An International Continence Society (ICS)/ International Urogynecological Association (IUGA) joint report on the terminology for the assessment and management of obstetric pelvic floor disorders.

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.

Incidence of obstetric anal sphincter injuries following breech compared to cephalic vaginal births.

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.

Functional and sexual outcomes following surgical vaginal introital reduction.

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.

Anterior bilateral sacrospinous ligament fixation with concomitant anterior native tissue repair: a pilot study.

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.

Urinary and sexual impact of pelvic reconstructive surgery for genital prolapse by surgical route. A randomized controlled trial.

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.

Safety and Efficacy of a Novel Barrier Film to Prevent Intrauterine Adhesion Formation after Hysteroscopic Myomectomy: The PREG1 Clinical Trial.

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.

Stress urinary incontinence after transvaginal mesh surgery for anterior and apical prolapse: preoperative risk factors.

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.

Reoperation rate and outcomes following the placement of polypropylene mesh by the vaginal route for cystocele: very long-term follow-up.

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.

French validation of the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA revised (PISQ-IR).

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.

Prospective ultrasonographic follow-up of transvaginal lightweight meshes: a 1-year multicenter study.

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 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%. 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.

A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery (INSTRUMODA).

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 ).

In Vivo Evaluation of the Efficacy and Safety of a Novel Degradable Polymeric Film for the Prevention of Intrauterine Adhesions.

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.

Is polypropylene mesh material fundamentally safe for use as a reconstructive material in vaginal surgery: ICI-RS 2019?

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.

Long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse.

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.

Abnormal vaginal microbiome associated with vaginal mesh complications.

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.