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.

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.

["Do uro-gynecology multidisciplinary team meeting modify therapeutic management?"] / « Les réunions de concertation pluridisciplinaire de pelvi-périnéologie modifient-elles les prises en charges thérapeutiques ? ¼.

INTRODUCTION: Since the banning of trans-vaginal meshes for pelvic organ prolapse treatment by the FDA in 2019, French authorities have been gradually regulating the use of prosthetic materials in urogynecology. The decision to fit a mid-urethral sling or a reinforcement implant for the cure of prolapse, as well as the management of complex genital prolapse and serious post-implant complications, must be the subject of multidisciplinary consultation and a shared medical decision. To comply with these regulations, multidisciplinary team meetings (MDTMs) have been set up. The aim of the study was to evaluate the impact of these meetings on patient management. MATERIAL: We carried out a retrospective study in a tertiary hospital in France on all cases presented in MDTM of urogynecology over the year 2022. MDTMs were held weekly, with a "Prosthesis MDTM" focusing on slings, sacrocolpo/hysteropexies and prosthetic complications, lead by the urology team, and a "Prolapse MDTM" focusing on pelvic organ prolapse and complex prolapses, lead by the gynecology team. We compared the initial proposal of the patient's referring physician versus the final proposal of the MDTM. RESULTS: Three hundred and seventy-five cases were presented in our center in 2022: 188 in Prosthetic MDTM and 187 in Prolapse MDTM. The Prosthetic and Static MDTMs agreed with the initial proposal in 83 and 64% of cases respectively, while the therapeutic strategy was questioned in 12 and 36% of cases respectively. CONCLUSION: For almost a quarter (24%) of patients, the MDTM of urogynecology opted for a different management from that proposed by the referring physician. The presentation of cases to the MDTM is a legal obligation in specific indications. It also plays an educational role, enabling shared decision-making and responsibility, which is an asset in functional surgery.

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.

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.

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.

[Photobiomodulation and vulvovaginal disorders after anticancer treatments]. / Photobiomodulation et troubles vulvovaginaux après traitements anticancéreux.

Anticancer treatments induce vulvovaginal complications that alter the quality of life and sexuality of patients. New technologies, such as photobiomodulation, could address this problem, for which few effective therapeutic solutions exist. The objective of this study was to describe the characteristics of patients seeking treatment and to observe the effects of photobiomodulation. This is a prospective cohort of patients treated for cancer, in failure of first-line medical treatment, managed at the University Hospital of Nîmes. The history, symptoms and impact of the disorders on their quality of life were collected. At follow-up, improvement was assessed using the PGI-I and FSFI questionnaires. Twenty-eight patients were treated. They were all menopausal, half of them after anticancer treatments [chemotherapy (78%), radiotherapy (36%), hormone therapy (36%)]. The main symptom reported was vaginal dryness (72%). Seventy-one percent of patients (n=20) felt that their daily life was affected≥8/10. All patients had sexual dysfunction. Twenty-two patients received at least 6 sessions of photobiomodulation. Seventy-two percent (n=18) of patients felt better or much better after treatment (PGI-I≤2). The median improvement estimated by the patients was 65% (Q1=50%; Q3=72.5%). There was also a significant clinical improvement. No serious adverse events were reported. Due to the small number of patients in a heterogeneous population with no control group, we cannot extrapolate our results. However, the objective was to assess the status of these pathologies and the contribution of photobiomodulation in patients who have failed first-line treatment; and these results are encouraging.

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.

Do Surgeons Anticipate Women's Hopes and Fears Associated with Prolapse Repair? A Qualitative Analysis in the PROSPERE Trial.

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.

Identification of Key Factors Influencing the Choice of the Type of Vaginal Pessary for Women Presenting with Pelvic Organ Prolapse: Semi-Directive Interviews and Development of an Algorithm.

(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.

Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse.

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.

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.

Clinical outcomes following surgical management of deep infiltrating endometriosis.

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.

Summary: 2021 International Consultation on Incontinence Evidence-Based Surgical Pathway for Pelvic Organ Prolapse.

(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.

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.

Vaginal Pessary for Pelvic Organ Prolapse: A French Multidisciplinary Survey.

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.