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RESEARCH QUESTION: How do different warning indicators help to identify disabling dysmenorrhoea among women in young adulthood? DESIGN: A nationwide cross-sectional study of women aged 18-25 years from the CONSTANCES cohort was constructed. Disability was assessed with the Global Activity Limitation Indicator question 'For the past 6 months, have you been limited in routine activities?Yes, severely limited/Yes, limited/ No, not limited'. Dysmenorrhoea pain intensity and other chronic pelvic pain symptoms (dyspareunia and non-menstrual pain) were evaluated according to questions from a specific questionnaire. Probability of disability was estimated using a logistic prediction model according to dysmenorrhoea intensity, other indicators of pelvic pain symptoms and other obvious covariates. The results of the predictive model of disabling dysmenorrhoea were presented on a nomogram. RESULTS: Among 6377 women, the rate of disability was estimated at 7.5%. Increased intensity of dysmenorrhoea (odds ratio [OR] 1.08, 95% confidence interval [CI] 1.04-1.13), increased frequency of dyspareunia (from OR 1.69, 95% CI 1.33-2.14 up to OR 3.41, 95% CI 2.16-5.38) non-menstrual chronic pelvic pain (OR 1.75, 95% CI 1.40-2.19), body mass index over 25 kg/m2 (OR 1.45, 95% CI 1.17-1.80) and non-use of the hormonal contraceptive pill (OR 1.29, 95% CI 1.05-1.59) were significantly associated with disability. According to the nomogram, a predicted probability of 15% or more could be chosen as a threshold. This represents almost 4.6% of young women in this sample being classified at risk of disabling dysmenorrhoea. CONCLUSIONS: Dysmenorrhoea pain intensity and associated pelvic pain symptoms are warning indicators that can be measured to help screen young women who may suffer from disabling dysmenorrhoea.
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Dismenorreia , Humanos , Feminino , Dismenorreia/epidemiologia , Estudos Transversais , Adulto Jovem , Adulto , Adolescente , Dor Pélvica/epidemiologia , Dor Pélvica/diagnóstico , Dispareunia/epidemiologia , Dispareunia/diagnóstico , Inquéritos e Questionários , Estudos de CoortesRESUMO
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.
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Slings Suburetrais , Incontinência Urinária por Estresse , Feminino , Humanos , Incontinência Urinária por Estresse/cirurgia , Incontinência Urinária por Estresse/etiologia , Slings Suburetrais/efeitos adversos , Telas Cirúrgicas , Procedimentos Cirúrgicos Urológicos/métodos , ReoperaçãoRESUMO
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.
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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.
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Episiotomia , Lacerações , Feminino , Gravidez , Humanos , Episiotomia/efeitos adversos , Estudos de Coortes , Estudos Prospectivos , Parto Obstétrico/efeitos adversos , França/epidemiologia , Lacerações/epidemiologia , Lacerações/etiologia , Lacerações/prevenção & controleRESUMO
INTRODUCTION AND HYPOTHESIS: The objective was to assess the intraobserver intersession and interobserver intrasession reliability of shear wave elastography applied to the external anal sphincter in term pregnant women. METHODS: This prospective study involved nulliparous pregnant women at 37 weeks or more with two visits (V1: one observer; V2 two observers) planned within a 12-h to 7-day interval. Measurements were performed using an Aixplorer V12® device with an SL 18-5 linear probe using a transperineal approach, allowing a measurement of the shear modulus (SM) in kPa. Measures were performed at rest, Valsalva maneuver, and maximal contraction. Reliability was assessed using the intraclass correlation coefficient (ICC). The study was approved by an ethics committee (ID RCB: 2020-A00764-65). RESULTS: A total of 37 women were included. Intraobserver reliability was excellent at rest (ICC = 0.91 [0.84-0.95) and good during the Valsalva maneuver (ICC = 0.83 [0.72-0.90]) and contraction (ICC = 0.85 [0.75-0.91]). Interobserver reliability was good at rest (ICC = 0.79 [0.66-0.87]) and during Valsalva (ICC = 0.84 [0.73-0.90]), but moderate during contraction (ICC = 0.70 [0.53-0.82]). CONCLUSIONS: Shear wave elastography is a reliable tool for assessing the elastic properties of the external anal sphincter in term pregnant women.
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Técnicas de Imagem por Elasticidade , Gestantes , Humanos , Feminino , Gravidez , Canal Anal/diagnóstico por imagem , Reprodutibilidade dos Testes , Estudos ProspectivosRESUMO
OBJECTIVE: We aimed to investigate changes in the elastic properties of levator ani muscle (LAM) and external anal sphincter (EAS) during pregnancy using shear wave elastography (SWE). Our secondary objective was to examine the association between the elastic properties of pelvic floor muscles (PFM) and perineal tears at childbirth. METHODS: This was a prospective monocentric study, including nulliparous women. Three visits were planned (14-18, 24-28, and 34-38 weeks) with a SWE assessment of the LAM and EAS at rest and during Valsalva maneuver. Then, we collected data about the delivery's characteristics. Assessments were performed using an Aixplorer V12® device (SL 18-5 linear probe) using a transperineal approach, reporting the shear modulus in kPa. We looked for changes in PFM's elastic properties during pregnancy using one-way ANOVA for repeated measures. We compared the mean shear modulus in late pregnancy for each muscle and condition between women with an intact perineum at delivery and those with a perineal tear using Student's t test. RESULTS: Forty-seven women were considered. Forty-five women had vaginal delivery of which 38 (84.4%) had perineal tears. We did not report any significant changes in the elastic properties of PFM during pregnancy. Women with an intact perineum at delivery had a stiffer EAS at Valsalva maneuver in late pregnancy (27.0 kPa vs. 18.2 kPa; p < 0.005). CONCLUSIONS: There were no significant changes in the elastic properties of the PFM in pregnancy. Stiffer EAS in late pregnancy appears to be associated with a lower incidence of perineal tears.
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Importance: Vacuum aspiration is commonly used to remove retained products of conception in patients with incomplete spontaneous abortion. Scarring of the uterine cavity may occur, potentially impairing future fertility. A procedural alternative, operative hysteroscopy, has gained popularity with a presumption of better future fertility. Objective: To assess the superiority of hysteroscopy to vacuum aspiration for subsequent pregnancy in patients with incomplete spontaneous abortion who intend to have future pregnancy. Design, Setting, and Participants: The HY-PER randomized, controlled, single-blind trial included 574 patients between November 6, 2014, and May 3, 2017, with a 2-year duration of follow-up. This multicenter trial recruited patients in 15 French hospitals. Individuals aged 18 to 44 years and planned for surgery for an incomplete spontaneous abortion with plans to subsequently conceive were randomized in a 1:1 ratio. Interventions: Surgical treatment by hysteroscopy (n = 288) or vacuum aspiration (n = 286). Main Outcomes and Measures: The primary outcome was a pregnancy of at least 22 weeks' duration during 2-year follow-up. Results: The intention-to-treat analyses included 563 women (mean [SD] age, 32.6 [5.4] years). All aspiration procedures were completed. The hysteroscopic procedure could not be completed for 19 patients (7%), 18 of which were converted to vacuum aspiration (8 with inability to completely resect, 7 with insufficient visualization, 2 with anesthetic complications that required a shortened procedure, 1 with equipment failure). One hysteroscopy failed due to a false passage during cervical dilatation. During the 2-year follow-up, 177 patients (62.8%) in the hysteroscopy group and 190 (67.6%) in the vacuum aspiration (control) group achieved the primary outcome (difference, -4.8% [95% CI, -13% to 3.0%]; P = .23). The time-to-event analyses showed no statistically significant difference between groups for the primary outcome (hazard ratio, 0.87 [95% CI, 0.71 to 1.07]). Duration of surgery and hospitalization were significantly longer for hysteroscopy. Rates of new miscarriages, ectopic pregnancies, Clavien-Dindo surgical complications of grade 3 or above (requiring surgical, endoscopic, or radiological intervention or life-threatening event or death), and reinterventions to remove remaining products of conception did not differ between groups. Conclusions and Relevance: Surgical management by hysteroscopy of incomplete spontaneous abortions in patients intending to conceive again was not associated with more subsequent births or a better safety profile than vacuum aspiration. Moreover, operative hysteroscopy was not feasible in all cases. Trial Registration: ClinicalTrials.gov Identifier: NCT02201732.
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Aborto Espontâneo , Gravidez Ectópica , Gravidez , Humanos , Feminino , Adulto , Curetagem a Vácuo , Método Simples-Cego , HisteroscopiaRESUMO
OBJECTIVES: To compare the incidence of cephalic marks in newborns exposed to operative vaginal delivery and those who are not. We examined the factors associated with alterations in neonatal well-being and with cephalic mark occurrence. METHODS: Prospective study involving singleton term newborns delivered in a cephalic presentation. Newborns in the operative group were matched with newborns born on the same day without instruments required. A cephalic mark was defined as any mark or edema on the newborn's skin between 12 and 72 hours of life. Neonatal well-being was assessed by analgesic consumption, neonatal discomfort (EDIN score of 1 or more), and prolonged hospitalization (4 days or more). We compared the operative and spontaneous groups and determined the relative risk (RR) for cephalic marks. We investigated the factors associated with alterations in neonatal well-being and factors associated with cephalic mark occurrence in the case of operative delivery using multivariate logistic regression analysis. RESULTS: A total of 135 newborns were included in each group. The incidence of cephalic marks was higher in the operative group (RR = 13.3 [6.0-29.5]). In case of operative delivery, cephalic marks were associated with neonatal discomfort (adjusted odds ratios [aOR] = 8.2 [2.2-30.6]) and analgesic consumption (aOR = 3.0 [1.2-7.1]). The number of cephalic marks was higher in cases with sequential use of vacuum and forceps (aOR = 3.5 [1.1-11.7]) and forceps only deliveries (aOR = 3.0 [1.1-8.1]) relative to vacuum only deliveries. CONCLUSIONS: Operative delivery increases the risk of neonatal cephalic marks, which can negatively affect neonatal well-being.
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Forceps Obstétrico , Vácuo-Extração , Parto Obstétrico , Feminino , Humanos , Recém-Nascido , Razão de Chances , Gravidez , Estudos Prospectivos , Vácuo-Extração/efeitos adversosRESUMO
AIMS: Our goal was to identify which women participating in an educational workshop on incontinence were most likely to benefit from it. METHODS: We included women aged 65 or older, living in the community, and not treated for incontinence despite reporting urinary leakage at least twice a week. The workshop's aims were to change beliefs about accepting incontinence as a normal part of ageing, explain that incontinence is not irreversible, and that solutions exist. We performed structured interviews at 6 and 12 months to assess impressions of improvement (PGI-I) and changes in both continence (ICIQ-FLUTS) and quality of life (I-QOL). RESULTS: The analysis included 392 women, 39% aged 80 or older and 57% with daily urinary incontinence. Twelve months after the workshop, 16% of women were "much better" (PGI-I); factors associated with impression of improvement were refusal to believe that incontinence is part of normal ageing at baseline and improvement of urinary symptoms. The median improvement was 4 points on the ICIQ-FLUTS and 8 on the I-QOL. Factors associated with a clinically significant improvement in urinary symptoms were more severe baseline urinary incontinence, obesity, and starting Kegel exercises. Factors associated with a clinically significant improvement in quality of life were a poor urinary quality of life at baseline and an age younger than 81 years. CONCLUSIONS: A short, inexpensive and nonmedical intervention can change the mind-set and behavior of older women with incontinence who are not seeking care. A clinically significant improvement is possible even in women with severe symptoms.
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Educação/normas , Qualidade de Vida/psicologia , Incontinência Urinária/terapia , Idoso de 80 Anos ou mais , Envelhecimento , Feminino , Humanos , Vida Independente , Resultado do TratamentoRESUMO
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 ).
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Canal Anal/lesões , Parto Obstétrico/efeitos adversos , Episiotomia/métodos , Complicações do Trabalho de Parto/epidemiologia , Avaliação de Resultados em Cuidados de Saúde/normas , Consenso , Episiotomia/efeitos adversos , Feminino , Humanos , Masculino , Estudos Observacionais como Assunto/normas , Complicações do Trabalho de Parto/etiologia , Complicações do Trabalho de Parto/prevenção & controle , Obstetrícia/estatística & dados numéricos , Gravidez , Estudos Prospectivos , Projetos de Pesquisa , Participação dos Interessados , Inquéritos e Questionários/estatística & dados numéricosRESUMO
BACKGROUND: Many countries currently recommend that screening for cervical cancer begin at the age of 25 years. Premature screening (before that age) could lead to unnecessary follow-up examinations and procedures that turn out to be useless. Our objective is to ascertain if the use of particular contraceptive methods are associated with premature screening. METHODS: This cross-sectional study based on the CONSTANCES cohort enabled us to include 4297 women younger than 25 years. The factors associated with premature screening were modeled by logistic regression. Missing data were handled by multiple imputations. The multivariate analyses were adjusted for sex life, social and demographic characteristics, and health status. RESULTS: Nearly half (48.5%) the women younger than 25 years had already undergone premature screening. Women not using contraceptives (aOR 0.3, 95% CI 0.3-0.5) and those using nonmedicalized contraceptives (condom, spermicide, etc.) (aOR 0.5, 95% CI 0.4-0.6) had premature screening less often than women using birth control pills. Higher risks of premature screening were observed in 20-year-old women (aOR 2.7, 95% CI 2.2-3.3) and in those with more than 5 lifetime partners (aOR 2.5, 95% CI 2.0-3.1), compared respectively with women who were younger and those with 5 or fewer lifetime partners. CONCLUSION: Young women using contraceptives that require a doctor's prescription are exposed to premature screening more often than those not using contraception and those with nonmedicalized contraceptives.
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Anticoncepção , Teste de Papanicolaou , Adulto , Estudos de Coortes , Estudos Transversais , Feminino , Humanos , Programas de Rastreamento , Adulto JovemRESUMO
AIMS: To analyze factors related to the incidence and remission of stress urinary incontinence (SUI), urge urinary incontinence (UUI), and mixed urinary incontinence (MUI) among women at midlife. METHODS: A total of 2115 women participants in a prospective longitudinal survey (GAZEL cohort) were included. In 2000 and 2008, a specific questionnaire about urinary incontinence (UI) symptoms was sent to all participants. Incidence, remission, and risk factors associated with each type of UI were considered. RESULTS: Within our population followed up for 8 years, we observed an overall incidence rate of UI of 21.9% (95% CI, 19.6-24.2%) and a remission rate of 33.3% (30.1-36.5%). For the different UI types, the incidence and remission rates were respectively 14.9% (12.9-24.2%) and 37.9% (37.8-42.0%) for SUI, 3.2% (2.2-4.2%) and 25.5% (3.5-37.5%) for UUI, 3.1% (2.1-4.1%) and 24.6% (19.3-29.9%) for MUI. Educational level, increase in body mass index (BMI), BMI and depression at inclusion were associated with SUI incidence. The history of surgery for UI was associated with the incidence of UUI and MUI. Surgery for SUI was significantly associated with remission, while pelvic floor rehabilitation and vaginal delivery were significantly associated with a lower SUI remission. Vaginal delivery was also negatively associated with MUI remission. CONCLUSIONS: The influence of the standard risk factors seems to differ in each type of UI.
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Incontinência Urinária por Estresse/epidemiologia , Incontinência Urinária de Urgência/epidemiologia , Idoso , Índice de Massa Corporal , Parto Obstétrico/efeitos adversos , Depressão , Feminino , Humanos , Incidência , Estudos Longitudinais , Pessoa de Meia-Idade , Diafragma da Pelve/fisiopatologia , Estudos Prospectivos , Fatores de Risco , Inquéritos e Questionários , Incontinência Urinária por Estresse/etiologia , Incontinência Urinária de Urgência/etiologiaRESUMO
INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) surgery using a mesh has a complication rate of 26%, and an estimated 10% of those operated on do not consider it brings improvement. The objective of this study was to identify preoperative predictors of improvement after POP repair with mesh to develop a predictive score. METHODS: This is a secondary analysis of the randomized multicenter trial PROSPERE, which compared morbidity after prolapse repair with mesh according to the vaginal or laparoscopic approach. Improved women [PGI-I score at 1-year follow-up = 1 (much better) or 2 (better)] were compared with unimproved women. Two hundred fifty-five women were included to derive the prediction score based on multiple logistic regression. An internal validation by bootstrapping estimated the unbiased performance of the model. RESULTS: Criteria independently related to improvement were: (1) cystocele stage > II [OR: 2.93 95% CI (1.22-7.04), p = 0.015]; (2) preoperative expectation related to bulge symptom improvement [OR: 2.57 95% CI (1.07-6.04), p = 0.031] and (3) absence of chronic pelvic pain [OR: 4.55 95% CI (1.77-11.46), p = 0.001]. A score (scored from 0 to 11) was constructed from the aOR of the predictive model: the ROC-AUC of the score was 0.75, and a score ≥ 9 predicted a 97% chance of improvement (95% CI 92-99), with a specificity of 85% (95% CI 68-94). The ROC-AUC corrected for optimism by the bootstrap procedure was 0.70. CONCLUSIONS: This score could be used by surgeons in preoperative counseling of women.
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Cistocele , Prolapso de Órgão Pélvico , Feminino , Humanos , Prolapso de Órgão Pélvico/cirurgia , Percepção , Telas Cirúrgicas , Resultado do Tratamento , VaginaRESUMO
BACKGROUND: Animal studies have reported an increase in pelvic floor muscle stiffness during pregnancy, which might be a protective process against perineal trauma at delivery. Our main objective is to describe the changes in the elastic properties of the pelvic floor muscles (levator ani, external anal sphincter) during human pregnancy using shear wave elastography (SWE) technology. Secondary objectives are as follows: i) to look for specific changes of the pelvic floor muscles compared to peripheral muscles; ii) to determine whether an association between the elastic properties of the levator ani and perineal clinical and B-mode ultrasound measures exists; and iii) to provide explorative data about an association between pelvic floor muscle characteristics and the risk of perineal tears. METHODS: Our prospective monocentric study will involve three visits (14-18, 24-28, and 34-38 weeks of pregnancy) and include nulliparous women older than 18 years, with a normal pregnancy and a body mass index (BMI) lower than 35 kg.m- 2. Each visit will consist of a clinical pelvic floor assessment (using the Pelvic Organ Prolapse Quantification system), an ultrasound perineal measure of the anteroposterior hiatal diameter and SWE assessment of the levator ani and the external anal sphincter muscles (at rest, during the Valsalva maneuver and during pelvic floor contraction), and SWE assessment of both the biceps brachii and the gastrocnemius medialis (at rest, extension and contraction). We will collect data about the mode of delivery and the occurrence of perineal tears. We will investigate changes in continuous variables collected using the Friedman test. We will look for an association between the elastic properties of the levator ani muscle and clinical / ultrasound measures using a Spearman test at each trimester. We will investigate the association between the elastic properties of the pelvic floor muscles and perineal tear occurrence using a multivariate analysis with logistic regression. DISCUSSION: This study will provide original in vivo human data about the biomechanical changes of pregnant women's pelvic floor. The results may lead to an individualized risk assessment of perineal trauma at childbirth. TRIAL REGISTRATION: This study was registered on https://clinicaltrials.gov on July 26, 2018 (NCT03602196).
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Canal Anal/lesões , Técnicas de Imagem por Elasticidade/métodos , Diafragma da Pelve/lesões , Períneo/lesões , Cuidado Pré-Natal/métodos , Canal Anal/diagnóstico por imagem , Parto Obstétrico , Feminino , Humanos , Parto , Diafragma da Pelve/diagnóstico por imagem , Diafragma da Pelve/fisiologia , Gravidez , Estudos Prospectivos , Projetos de PesquisaRESUMO
BACKGROUND: In France, a Pap test for cervical cancer screening is recommended every three years for all sexually active women aged 25 to 65 years. Modes of contraception (any or no contraception, with or without a visit to a physician, and with or without a gynecological examination) may influence adhesion to screening: women who use intrauterine device (IUD) should be more up to date with their cervical cancer screening more often than those using other means of contraception. Our objectives were to analyze the association between modes of contraception and Pap tests for screening. METHODS: This cross sectional study is based on the CONSTANCES cohort enabled us to include 16,764 women aged 25-50 years. The factors associated with adhesion to cervical cancer screening (defined by a report of a Pap test within the previous 3 years) was modeled by logistic regression. Missing data were imputed by using multiple imputations. The multivariate analyses were adjusted for sex life, social and demographic characteristics, and health status. RESULTS: Overall, 11.2% (1875) of the women reported that they were overdue for Pap test screening. In the multivariate analysis there was no significant difference between women using an IUD and those pills or implant of pap test overdue ORa:0.9 CI95% [0.8-1.1], ORa 1.3 CI95% [0.7-2.7] respectively. Women not using contraceptives and those using non-medical contraceptives (condoms, spermicides, etc.) were overdue more often ORa: 2.6 CI95% [2.2-3.0] and ORa: 1.8 CI95% [1.6-2.1] respectively than those using an IUD. CONCLUSION: Women seeing medical professionals for contraception are more likely to have Pap tests.
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Anticoncepção/métodos , Detecção Precoce de Câncer/estatística & dados numéricos , Programas de Rastreamento/estatística & dados numéricos , Teste de Papanicolaou/estatística & dados numéricos , Neoplasias do Colo do Útero/diagnóstico , Esfregaço Vaginal/estatística & dados numéricos , Adulto , Idoso , Anticoncepção/estatística & dados numéricos , Estudos Transversais , Detecção Precoce de Câncer/métodos , Feminino , França , Humanos , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Cooperação do Paciente/estatística & dados numéricos , Adulto JovemRESUMO
AIMS: To evaluate the safety and efficacy of the Uphold LITE mesh in the treatment of pelvic organ prolapse at 12-month follow-up. METHODS: Women undergoing a mesh surgery due to an anterior prolapse plus a symptomatic anterior prolapse (classed as pelvic organ prolapse quantification stage ≥2) were included in this prospective, multicentre, observational study. The primary endpoint was a composite outcome including a good anatomical correction, no prolapse symptoms, and no reintervention for an anterior or apical recurrent prolapse within 12 months of surgery. Secondary outcomes included safety, improvements in quality of life (QoL), and risk factor for recurrence. This study was registered with ClinicalTrials.gov, number NCT01559168. RESULTS: A total of 121 patients were included. Symptomatic and anatomic cure rates were 94% (95 of 101) and 76.8% (76 of 99), respectively. The composite success rate was 72.4% (71 of 98). The rate of reoperation for apical or anterior recurrent prolapse was 3.9% (4 of 103). Anatomical anterior or apical recurrence occurred in 18.2% (18 of 97) and 7.2% (7 of 97) of patients, respectively. The composite success rate was significantly higher in centres where more than 30 patients had been treated (80% vs 50%; P = .045). The rate of serious complication was 5.4% (6 of 111). Improvements were recorded in QoL including sexual function. CONCLUSIONS: The Uphold LITE mesh procedure provides satisfactory outcomes in the treatment of anterior and apical prolapse, particularly in high-volume centres. The rates of adverse effects and reintervention for recurrent prolapse were acceptable.
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Prolapso de Órgão Pélvico/cirurgia , Telas Cirúrgicas , Procedimentos Cirúrgicos Urológicos/métodos , Idoso , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Segurança do Paciente , Prolapso de Órgão Pélvico/psicologia , Estudos Prospectivos , Qualidade de Vida , Recidiva , Reoperação , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: The long-term effectiveness of group continence promotion delivered via community organisations on female urinary incontinence, falls and healthy life expectancy remains unknown. METHODS: A pragmatic cluster randomised trial was conducted among 909 women aged 65-98 years with urinary incontinence, recruited from 377 community organisations in the UK, Canada and France. A total of 184 organisations were randomised to an in-person 60-min incontinence self-management workshop (461 participants), and 193 to a control healthy ageing workshop (448 participants). The primary outcome was self-reported incontinence improvement at 1-year. Falls and gains in health utility were secondary outcomes. RESULTS: A total 751 women, mean age 78.0, age range 65-98 completed the trial (83%). At 1-year, 15% of the intervention group versus 6.9% of controls reported significant improvements in urinary symptoms, (difference 8.1%, 95% confidence intervals (CI) 4.0-12.1%, intracluster correlation 0.04, number-needed-to-treat 13) and 35% versus 19% reported any improvement (risk difference 16.0%, 95% CI 10.4-21.5, number-needed-to-treat 6). The proportion of fallers decreased from 42% to 36% in the intervention group (-8.0%, 95% CI -14.8 - -1.0) and from 44% to 34% in the control group (-10.3%, 95% CI -17.4 - -3.6), no difference between groups. Both intervention and control groups experienced a gain in health utility (0.022 points (95% CI 0.005-0.04) versus 0.035 (95% CI 0.017-0.052), respectively), with no significant difference between groups. CONCLUSION: Community-based group continence promotion achieves long-term benefits on older women's urinary symptoms, without improvement in falls or healthy life expectancy compared with participation in a healthy ageing workshop.
Assuntos
Acidentes por Quedas/prevenção & controle , Serviços de Saúde Comunitária/métodos , Promoção da Saúde/métodos , Envelhecimento Saudável , Expectativa de Vida , Incontinência Urinária/prevenção & controle , Acidentes por Quedas/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Educação , Feminino , Humanos , Comportamento de Redução do Risco , Autogestão/métodosRESUMO
INTRODUCTION AND HYPOTHESIS: Ultrasound measurement of urethral mobility is an attractive approach to directly visualize bladder neck descent (BND) during stress. BND assessed by transperineal ultrasound appears to be associated with stress urinary incontinence (SUI) severity. This study evaluated the inter- and intra-observer reliability of ultrasound BND measurement and its correlation with clinical examination. METHODS: We included 50 women from the multicenter randomized 3PN study ("Prenatal Perineal Prevention"). BND was measured by two operators either during pregnancy (at 20 weeks of gestation) or 2 months after delivery. Two measurements were taken by each operator. Intra-class coefficient correlations were used for analysis. Urethral mobility was clinically assessed by measuring the point Aa of the POP-Q classification during maximum strain (Valsalva maneuver) with an empty bladder. RESULTS: Ultrasound analysis showed high intra-observer reliability in the overall population: intraclass correlation coefficients (ICC) = 0.75 (0.59-0.85) and 0.73 (0.55-0.84) for each operator. Intra-observer agreements were considered moderate to high in the post- and antepartum groups. Inter-observer agreements were moderate in the antepartum period [ICC = 0.58 (0.26-0.78) for the first measurement and 0.68 (0.42-0.84) for the second] but low in the postpartum period [ICC = 0.15 (0.10-0.41) and 0.21 (0.10-0.58)]. Correlations between ultrasound and clinical measurements were considered low to moderate (Spearman coefficient, rho = 0.34 and 0.50 for post- and antepartum periods, respectively). CONCLUSIONS: Inter-observer reliability of ultrasound urethral mobility measurements by the transperineal route is moderate antepartum and low postpartum. The correlation with point Aa is low to moderate.
Assuntos
Períneo/diagnóstico por imagem , Complicações na Gravidez/diagnóstico por imagem , Ultrassonografia/estatística & dados numéricos , Uretra/diagnóstico por imagem , Incontinência Urinária por Estresse/diagnóstico por imagem , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Variações Dependentes do Observador , Período Pós-Parto , Gravidez , Complicações na Gravidez/fisiopatologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Reprodutibilidade dos Testes , Ultrassonografia/métodos , Ultrassonografia Pré-Natal/métodos , Ultrassonografia Pré-Natal/estatística & dados numéricos , Uretra/fisiopatologia , Incontinência Urinária por Estresse/fisiopatologia , Manobra de ValsalvaRESUMO
INTRODUCTION AND HYPOTHESIS: We hypothesized that shear wave elastography (SWE) technology might be useful for assessing the elastic properties of the pelvic floor in women. Our primary objective was to evaluate the feasibility of assessing the levator ani muscles using SWE in women. Our secondary aim was to investigate the changes in their elastic properties from rest to Valsalva maneuver. METHODS: During this prospective feasibility study in nonpregnant female volunteers, we collected data on participant age, body mass index (BMI), parity, and time since the delivery. The levator ani muscles of each participant were assessed using SWE technology at rest and during a Valsalva maneuver by measuring the shear modulus (in kilopascals). We then assessed the changes in the shear modulus at rest and during the Valsalva maneuver using a Wilcoxon test. RESULTS: Twelve parous women participated in this study. The mean time since the last delivery was 14 months, the mean age was 31 years, and mean BMI was 28 kg.m-2. All the assessments performed at rest were successfully completed, but we encountered two failures during the Valsalva maneuver. The mean shear modulus increased by a factor of more than 2 from rest to the Valsalva maneuver for both the right (16.0 vs 35.4 kPa) and left side (17.1 vs 37.6 kPa). CONCLUSIONS: An assessment of the elastic properties of the levator ani muscles is feasible for nonpregnant women. The reproducibility of the technique and its application in pregnant women and women with pelvic floor disorders must be investigated.
Assuntos
Técnicas de Imagem por Elasticidade/métodos , Elasticidade/fisiologia , Diafragma da Pelve/diagnóstico por imagem , Adulto , Estudos de Viabilidade , Feminino , Humanos , Estudos Longitudinais , Diafragma da Pelve/fisiologia , Estudos Prospectivos , Manobra de Valsalva/fisiologiaRESUMO
Perineal trauma at childbirth is associated with strong negative impacts on a woman's health but remains unpredictable. Pregnancy induces several changes in biomechanical behavior in humans as in animals, namely, an increase in ligamentous laxity and an increase in vaginal distensibility. Pelvic floor muscles in rats are reported to exhibit specific behaviors during pregnancy. Increases in both stiffness and the number of sarcomeres in series are observed and might process that protect against perineal trauma at childbirth. Some data in humans have shown that the risk of perineal trauma is highly linked to the intrinsic characteristics of the tissue, suggesting the potential benefit of incorporating intrinsic biomechanical characteristics in the risk prediction for perineal trauma. Shear wave elastography might be a useful noninvasive tool to investigate the elastic properties of these tissues in pregnant women in vivo, with the goal of implementing these properties as a predictive strategy.