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.
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.
PurposeMaintaining urinary continence at stress requires a competent urethral sphincter and good suburethral support. Sphincter competence is estimated by measuring the maximal urethral closure pressure at rest. We aimed to study the value of a new urodynamic measure, the urethral closure pressure at stress (s-UCP), in the diagnosis and severity of female stress urinary incontinence (SUI).MethodsA total of 400 women without neurological disorders were included in this observational study. SUI was diagnosed using the International Continence Society definition, and severity was assessed using a validated French questionnaire, the Mesure du Handicap Urinaire. The perineal examination consisted of rating the strength of the levator ani muscle (0–5) and an assessment of bladder neck mobility using point Aa (cm). The urodynamic parameters were maximal urethral closure pressure at rest, s-UCP, Valsalva leak point pressure (cm H2O), and pressure transmission ratio (%).ResultsOf the women, 358 (89.5%) were diagnosed with SUI. The risk of SUI significantly increased as s-UCP decreased (odds ratio [OR], 0.92; 95% confidence interval, 0.88–0.98). The discriminative value of the measure was good for the diagnosis of SUI (area under curve>0.80). s-UCP values less than or equal to 20 cm H2O had a sensitivity of 73.1% and a specificity of 93.0% for predicting SUI. The association between s-UCP and SUI severity was also significant.Conclusionss-UCP is the most discriminative measure that has been identified for the diagnosis of SUI. It is strongly inversely correlated with the severity of SUI. It appears to be a specific SUI biomarker reflecting both urethral sphincter competence and urethral support.
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.
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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