Serious complications and recurrences after pelvic organ prolapse surgery for 2309 women in the VIGI-MESH registry.

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.

Long-term outcomes of primary cystocele repair by transvaginal mesh surgery versus laparoscopic mesh sacropexy: extended follow up of the PROSPERE multicentre randomised trial.

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).

[Validation of a new self-questionnaire to assess sexuality in patients operated on for urinary incontinence or genital prolapse (Pelvi-Perineal Surgery Sexuality Questionnaire - PPSSQ)]. / Validation d'un nouvel auto-questionnaire d'évaluation de la sexualité chez les patientes opérées d'une incontinence urinaire ou d'un prolapsus génital (Pelvi-Perineal Surgery Sexuality Questionnaire ­ PPSSQ).

INTRODUCTION: The main objective of this study was to validate a new questionnaire evaluating sexual health, in a population of sexually active women or not, who have surgery for stress urinary incontinence or pelvic organ prolapse with or without mesh reinforcement. MATERIAL AND METHODS: After the development of a first version of the questionnaire by members from the main French societies involved in the study of women's sexuality, a linguistic validation of the content of the questionnaire was carried out through semi-structured interviews. Then, a psychometric validation was carried out in a prospective multicenter cohort study. The questionnaire was evaluated in terms of acceptability, quality, dimensionality, internal consistency, temporal stability, sensitivity to changes and construction validity. RESULTS: Linguistic validation was carried out in 25 patients. Psychometric validation was carried out in 297 women (291 with available data) operated on for urinary incontinence by midurethral sling (n=79) or for pelvic organ prolapse by the vaginal route with mesh (n=105), without mesh (n=22) or by laparoscopic sacrocolpopexy (n=85) between January 18, 2013 and January 18, 2016. Within the 288/291 women who had filed the question No. 1 allowing to know their sexual "status", 159 (55%) women were sexually active and 129 (45%) women were not sexually active before surgery. Within the 288 women, 165 had completed the questionnaire preoperatively and at 12 months and 111 had completed the questionnaire at 12 months and 12 months+1 week. The questionnaire was well accepted by the women and of good quality. All the questions were kept, but a change in the order and numbering of the questions had to be made. Two clinically relevant dimensions were identified in this analysis: a "sexual health" dimension comprising 5 questions and a "discomfort and pain" dimension comprising 3 questions. The overall questionnaire and both dimensions had good reliability and moderate to excellent temporal stability. A statistically significant association was demonstrated between question 15 and the improvement reported by PGI-I and the anatomical success rate on POP-Q classification. A strong correlation was found between the "sexual health" score and the total FSFI score. CONCLUSION: The Pelvi-Perineal Surgery Sexuality Questionnaire (PPSSQ) is a 13-question self-questionnaire validated in a population of sexually active women or not, operated on for stress urinary incontinence or pelvic organ prolapse by laparoscopy or vaginal surgery, with or without mesh. LEVEL OF EVIDENCE: 4.

Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry.

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.

[An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and non-pharmacological management of female pelvic floor dysfunction]. / Traduction française de la terminologie commune de l'International Urogynecological Association (IUGA) et de l'International Continence Society (ICS) relative à la prise en charge conservatrice et non pharmacologique des troubles pelvi-périnéaux de la femme.

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.

Perineal prevention and protection in obstetrics: CNGOF clinical practice guidelines.

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.

Surgical management of pelvic organ prolapse.

Despite pelvic organ prolapse being a universal problem experienced in nearly 50% of parous women, the surgical management of vaginal prolapse remains an enigma to many, with wide variation in the rates and types of intervention performed. As part of the 6th International Consultation on Incontinence (ICI) our committee, charged with producing an evidence-based report on the surgical management of prolapse, produced a pathway for the surgical management of prolapse. The 2017 ICI surgical management of prolapse evidence-based pathway will be presented and summarized. Weaknesses of the data and pathway will be discussed and avenues for future research proposed.

[Childbirth pelvic floor trauma: Anatomy, physiology, pathophysiology and special situations - CNGOF perineal prevention and protection in obstetrics guidelines]. / Lésions pelvipérinéales obstétricales : anatomie, physiologie, physiopathologie et situations particulières. RPC prévention et protection périnéale en obstétrique CNGOF.

OBJECTIVES: To assess whether pelvic size and shape, spinal curvature, perineal body length and genital hiatus size are associated with the incidence of childbirth pelvic floor trauma. Special situations, such as obesity, ethnicity and hyperlaxity, will also be studied. METHODS: A bibliographic research using Pubmed and Cochrane Library databases was conducted until May 2018. Publications in English and French were selected by initial reading of the abstracts. Randomized trials, meta-analyzes, case-control studies and large cohorts were studied in a privileged way. RESULTS: A pubic arch angle<90° (measured clinically) does not appear to increase the risk of OASIS (Level 3), but appears to be a risk factor for postnatal anal incontinence at short-term, but not at long-term (Level 3). Measurement of pelvic dimensions and the subpubic angle is not recommended to predict OASIS or to choose the mode of delivery for the purpose of protecting the perineum (GradeC). Prenatal measurement of both perineal body (Level 3) and genital hiatus (Level 2) does not predict the incidence of 2nd or 3rd degree OASIS. Therefore, the routine prenatal measurement of the length of the perineal body or the genital hiatus is not recommended for any objective related to perineal protection (Grade C). Levator avulsion, resulting in a widening of the genital hiatus, is potentially a source of long-term pelvic floor dysfunction. Biomechanical models suggest that performing a mediolateral episiotomy and applying the fingers to the posterior perineum at the time of expulsive phase may reduce pelvic floor trauma. Obese women have a longer perineal body (Level 3), and obesity does not seem to increase the risk of OASIS (Level 2). There is no difference between Asian and non-Asian women perineal body (Level 3). No studies have validated that the liberal practice of episiotomy in Asian women reduced the risk of OASIS. It is therefore not recommended to practice an episiotomy for simple ethnic reasons in Asian women (GradeC). Compared to white women, black women do not appear to have an increased risk of OASIS and even appear to have a decreased risk of perineal tears of all stages (Level 2). Ligament hyperlaxity seems to be associated with an increased risk of OASIS (Level 2). CONCLUSIONS: Prenatal assessment of pelvis bone, spine curvature, perineal body and genital hiatus do not allow to predict the incidence of childbirth pelvic floor trauma. Obesity and ethnicity are not risk factors for OASIS.

[Perineal prevention and protection in obstetrics: CNGOF Clinical Practice Guidelines (short version)]. / Prévention et protection périnéale en obstétrique : Recommandations pour la Pratique Clinique du CNGOF (texte court).

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 (GradeC). In case of OASIS, the injuries (including their severity) and the technique for their repair should be described in detail (GradeC). 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 (GradeC). 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 (GradeC). 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.

Assessing the costs of disposable and reusable supplies wasted during surgeries.

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.

[Could we perform vaginal mesh surgery for treatment of pelvic organ prolapse in elderly women?] / La chirurgie vaginale prothétique peut-elle être proposée aux patientes âgées de plus de 75 ans ?

INTRODUCTION: Prevalence of pelvic organ prolapse will increase with the aging of the population. Concerning the treatment of pelvic organ prolapse, transvaginal route is often preferred for elderly women. However few data are available concerning transvaginal mesh surgery in this population. The aim of this study was to compare efficiency and complications of transvaginal mesh surgery between women aged over 75 and younger women. MATERIALS AND METHODS: A monocentric, retrospective study included all women who underwent anterior sacrospinous suspension with mesh for treatment of pelvic organ prolapse. The primary endpoint was anatomical success at the last follow-up, defined by a pelvic organ prolapse stage 0 or 1 of POP-Q classification. The secondary endpoints were rate of complications and urinary, colorectal and sexual functional results. RESULTS: We included 329 patients, 69 were under 75 years old and 260 were aged over 75. The median of follow-up was 12 months (IQR: 6). The rate of anatomical success was significantly higher in patients aged over 75: 92% versus 85% in younger patients (P=0.02). However this difference was no more significant in multivariate analysis after inclusion of confusions factors (P=0.82). The rate of perioperative complications was low and similar in the 2 groups even in multivariate analysis. CONCLUSION: Utero-vaginal suspension using bilateral vaginal anterior sacrospinous fixation with mesh seems to achieve at least similar results between women aged more than 75 years and younger women. There is no excess risk of complications in elderly women. LEVEL OF EVIDENCE: 4.

[What measures of perineal protection at birth are consensual in France? Results of a Delphi survey]. / Quelles mesures de protection périnéale à l'accouchement sont consensuelles en France ? Résultats d'une enquête Delphi.

OBJECTIVE: To evaluate expert's opinion in order to obtain a consensus on the different measures of perineal protection at the time of vaginal delivery. METHODS: A survey using the Delphi method was carried out with a panel of French obstetricians, urogynecologists and midwives. The questionnaire included 22 questions grouped into four groups: expulsive efforts, indications of episiotomy, episiotomy repair and other forms of perineal protection. The experts had to answer on a 9-point scale, both on the validity and the clarity of each proposal. After analysis of the replies of the first round, a second round was sent to the same experts for certain proposals. Each turn was the subject of two raises. To be validated, each proposal had to obtain a median equal to or greater than 7/9 and an agreement between the experts greater than 65% in the first round, and more than 75% in the second round. RESULTS: The study was conducted between March and October 2016. Of the 300 experts initially selected, 93 (31%) responded to the first round, including 63 obstetricians (67.7%), 12 urogynecologists (12.9%) and 18 midwives (19.4%). In the second round, 72 experts replied, representing 77.4% of the experts who also answered the first round. At the end of the two rounds, 11 proposals were validated, and 11 rejected. The following recommendations have been validated. Uterine expression should be proscribed. The two modes of pushing (blocked in Valsalva and by blowing) can be indifferently proposed, in case of fetal progression and in the absence of fetal distress. The midline episiotomy should be proscribed. The medio-lateral (or lateral) episiotomy should be left to the discretion of the accoucheur. The maintenance of the fetal head with one hand must be systematic to the expulsion to protect the perineum. Repair of the episiotomy should be made (except in some cases) with a rapid absorbable suture. The prescription of NSAIDs and/or painkillers of level 2 should be preferred to reduce the pain of post-natal perineal scars. CONCLUSION: Several measures of perineal protection at the time of vaginal delivery are consensual in France. Other measures should be studied further. LEVEL OF EVIDENCE: 4.

[Cultural adaptation of the female pelvic floor questionnaire (FPFQ) into French]. / Adaptation culturelle du Female Pelvic Floor Questionnaire (FPFQ) en langue française.

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