Clinical and cost-effectiveness of pessary self-management versus clinic-based care for pelvic organ prolapse in women: the TOPSY RCT with process evaluation.

Background: Pelvic organ prolapse is common, causes unpleasant symptoms and negatively affects women's quality of life. In the UK, most women with pelvic organ prolapse attend clinics for pessary care. Objectives: To determine the clinical effectiveness and cost-effectiveness of vaginal pessary self-management on prolapse-specific quality of life for women with prolapse compared with clinic-based care; and to assess intervention acceptability and contextual influences on effectiveness, adherence and fidelity. Design: A multicentre, parallel-group, superiority randomised controlled trial with a mixed-methods process evaluation. Participants: Women attending UK NHS outpatient pessary services, aged ≥ 18 years, using a pessary of any type/material (except shelf, Gellhorn or Cube) for at least 2 weeks. Exclusions: women with limited manual dexterity, with cognitive deficit (prohibiting consent or self-management), pregnant or non-English-speaking. Intervention: The self-management intervention involved a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a local clinic telephone helpline number. Clinic-based care involved routine appointments determined by centres' usual practice. Allocation: Remote web-based application; minimisation was by age, pessary user type and centre. Blinding: Participants, those delivering the intervention and researchers were not blinded to group allocation. Outcomes: The patient-reported primary outcome (measured using the Pelvic Floor Impact Questionnaire-7) was prolapse-specific quality of life, and the cost-effectiveness outcome was incremental cost per quality-adjusted life-year (a specifically developed health Resource Use Questionnaire was used) at 18 months post randomisation. Secondary outcome measures included self-efficacy and complications. Process evaluation data were collected by interview, audio-recording and checklist. Analysis was by intention to treat. Results: Three hundred and forty women were randomised (self-management, n = 169; clinic-based care, n = 171). At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available (self-management, n = 139; clinic-based care, n = 152). Baseline economic analysis was based on 264 participants (self-management, n = 125; clinic-based care, n = 139) with valid quality of life and resource use data. Self-management was an acceptable intervention. There was no group difference in prolapse-specific quality of life at 18 months (adjusted mean difference -0.03, 95% confidence interval -9.32 to 9.25). There was fidelity to intervention delivery. Self-management was cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, with an estimated incremental net benefit of £564.32 and an 80.81% probability of cost-effectiveness. At 18 months, more pessary complications were reported in the clinic-based care group (adjusted mean difference 3.83, 95% confidence interval 0.81 to 6.86). There was no group difference in general self-efficacy, but self-managing women were more confident in pessary self-management activities. In both groups, contextual factors impacted on adherence and effectiveness. There were no reported serious unexpected serious adverse reactions. There were 32 serious adverse events (self-management, n = 17; clinic-based care, n = 14), all unrelated to the intervention. Skew in the baseline data for the Pelvic Floor Impact Questionnaire-7, the influence of the global COVID-19 pandemic, the potential effects of crossover and the lack of ethnic diversity in the recruited sample were possible limitations. Conclusions: Self-management was acceptable and cost-effective, led to fewer complications and did not improve or worsen quality of life for women with prolapse compared with clinic-based care. Future research is needed to develop a quality-of-life measure that is sensitive to the changes women desire from treatment. Study registration: This study is registered as ISRCTN62510577. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/82/01) and is published in full in Health Technology Assessment; Vol. 28, No. 23. See the NIHR Funding and Awards website for further award information.

Pelvic organ prolapse is a common and distressing condition experienced by large numbers of women. Prolapse is when the organs that are usually in the pelvis drop down into the vagina. Women experience a feeling of something coming down into the vagina, along with bowel, bladder and sexual problems. One possible treatment is a vaginal pessary. The pessary is a device that is inserted into the vagina and holds the pelvic organs back in their usual place. Women who use a vaginal pessary usually come back to clinic every 6 months to have their pessary removed and replaced; this is called clinic-based care. However, it is possible for a woman to look after the pessary herself; this is called self-management. This study compared self-management with clinic-based care. Three hundred and forty women with prolapse took part; 171 received clinic-based care and 169 undertook self-management. Each woman had an equal chance of being in either group. Women in the self-management group received a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a telephone number for their local centre. Women in the clinic-based care group returned to clinic as advised by the treating healthcare professional. Self-management was found to be acceptable. Women self-managed their pessary in ways that suited their lifestyle. After 18 months, there was no difference between the groups in women's quality of life. Women in the self-management group experienced fewer pessary complications than women who received clinic-based care. Self-management costs less to deliver than clinic-based care. In summary, self-management did not improve women's quality of life more than clinic-based care, but it did lead to women experiencing fewer complications and cost less to deliver in the NHS. The findings support self-management as a treatment pathway for women using a pessary for prolapse.

Cost-effectiveness of 2 Models of Pessary Care for Pelvic Organ Prolapse: Findings From the TOPSY Randomized Controlled Trial.

OBJECTIVES: Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment option is pessary management. This study aimed to to investigate the cost-effectiveness of pessary self-management (SM) when compared with clinic-based care (CBC). A decision analytic model was developed to extend the economic evaluation. METHODS: A randomized controlled trial with health economic evaluation. The SM group received a 30-minute SM teaching session, information leaflet, 2-week follow-up call, and a local helpline number. The CBC group received routine outpatient pessary appointments, determined by usual practice. The primary outcome for the cost-effectiveness analysis was incremental cost per quality-adjusted life year (QALY), 18 months post-randomization. Uncertainty was handled using nonparametric bootstrap analysis. In addition, a simple decision analytic model was developed using the trial data to extend the analysis over a 5-year period. RESULTS: There was no significant difference in the mean number of QALYs gained between SM and CBC (1.241 vs 1.221), but mean cost was lower for SM (£578 vs £728). The incremental net benefit estimated at a willingness to pay of £20 000 per QALY gained was £564, with an 80.8% probability of cost-effectiveness. The modeling results were consistent with the trial analysis: the incremental net benefit was estimated as £4221, and the probability of SM being cost-effective at 5 years was 69.7%. CONCLUSIONS: Results suggest that pessary SM is likely to be cost-effective. The decision analytic model suggests that this result is likely to persist over longer durations.

Obstetric risk factors for levator ani muscle avulsion: A systematic review and meta-analysis.

OBJECTIVES: Women have a 11% lifetime risk of undergoing surgery for vaginal prolapse. Levator ani muscle (LAM) avulsion is one etiological factor associated with primary and recurrent pelvic organ prolapse. Pelvic organ prolapse has been shown to greatly affect the quality of life and well-being of women. Conduct a meta-analysis identifying risk factors associated with LAM avulsion recognised on transperineal ultrasound (TPUS) or magnetic resonance imaging (MRI) in primiparous women after vaginal birth. STUDY DESIGN: OVID Medline, Embase and the Cochrane Library from inception to January 2021 were searched. Review Manager 5.3 (The Cochrane Collaboration) was used to analyse data. Odds ratios (OR) with 95% confidence intervals (95% CIs) were calculated. The heterogeneity among studies was calculated using the I2statistic. RESULTS: Twenty-five studies were eligible for inclusion (n = 9333 women). Major LAM avulsion was diagnosed in an average of 22 % (range 12.7-39.5 %) of cases. Twenty-two studies used TPUS and three used MRI to diagnose avulsion. Modifiable and non-modifiable risk factors were identified. Significant predictors identified were forceps (OR 6.25 [4.33 - 9.0]), obstetric anal sphincter injuries (OR 3.93 [2.85-5.42]), vacuum (OR 2.41 [1.40-4.16]), and maternal age (OR 1.06 [1.02-1.10]). CONCLUSIONS: This is the first meta-analysis of both modifiable and non-modifiable risk factors associated with LAM avulsion. This information could be used to develop a clinically applicable risk prediction model to target postnatal women at risk of LAM avulsion with a view to prevent the onset of pelvic floor organ prolapse.

Neglected medium-term and long-term consequences of labour and childbirth: a systematic analysis of the burden, recommended practices, and a way forward.

Over the past three decades, substantial progress has been made in reducing maternal mortality worldwide. However, the historical focus on mortality reduction has been accompanied by comparative neglect of labour and birth complications that can emerge or persist months or years postnatally. This paper addresses these overlooked conditions, arguing that their absence from the global health agenda and national action plans has led to the misconception that they are uncommon or unimportant. The historical limitation of postnatal care services to the 6 weeks after birth is also a contributing factor. We reviewed epidemiological data on medium-term and long-term complications arising from labour and childbirth beyond 6 weeks, along with high-quality clinical guidelines for their prevention, identification, and treatment. We explore the complex interplay of human evolution, maternal physiology, and inherent predispositions that contribute to these complications. We offer actionable recommendations to change the current trajectories of these neglected conditions and help achieve the targets of Sustainable Development Goal 3. This paper is the third in a Series of four papers about maternal health in the perinatal period and beyond.

The prevention of perineal trauma during vaginal birth.

Perineal trauma after vaginal birth is common, with approximately 9 of 10 women being affected. Second-degree perineal tears are twice as likely to occur in primiparous births, with a incidence of 40%. The incidence of obstetrical anal sphincter injury is approximately 3%, with a significantly higher rate in primiparous than in multiparous women (6% vs 2%). Obstetrical anal sphincter injury is a significant risk factor for the development of anal incontinence, with approximately 10% of women developing symptoms within a year following vaginal birth. Obstetrical anal sphincter injuries have significant medicolegal implications and contribute greatly to healthcare costs. For example, in 2013 and 2014, the economic burden of obstetrical anal sphincter injuries in the United Kingdom ranged between £3.7 million (with assisted vaginal birth) and £9.8 million (with spontaneous vaginal birth). In the United States, complications associated with trauma to the perineum incurred costs of approximately $83 million between 2007 and 2011. It is therefore crucial to focus on improvements in clinical care to reduce this risk and minimize the development of perineal trauma, particularly obstetrical anal sphincter injuries. Identification of risk factors allows modification of obstetrical practice with the aim of reducing the rate of perineal trauma and its attendant associated morbidity. Risk factors associated with second-degree perineal trauma include increased fetal birthweight, operative vaginal birth, prolonged second stage of labor, maternal birth position, and advanced maternal age. With obstetrical anal sphincter injury, risk factors include induction of labor, augmentation of labor, epidural, increased fetal birthweight, fetal malposition (occiput posterior), midline episiotomy, operative vaginal birth, Asian ethnicity, and primiparity. Obstetrical practice can be modified both antenatally and intrapartum. The evidence suggests that in the antenatal period, perineal massage can be commenced in the third trimester of pregnancy to increase muscle elasticity and allow stretching of the perineum during birth, thereby reducing the risk of tearing or need for episiotomy. With regard to the intrapartum period, there is a growing body of evidence from the United Kingdom, Norway, and Denmark suggesting that the implementation of quality improvement initiatives including the training of clinicians in manual perineal protection and mediolateral episiotomy can reduce the incidence of obstetrical anal sphincter injury. With episiotomy, the International Federation of Gynecology and Obstetrics recommends restrictive rather than routine use of episiotomy. This is particularly the case with unassisted vaginal births. However, there is a role for episiotomy, specifically mediolateral or lateral, with assisted vaginal births. This is specifically the case with nulliparous vacuum and forceps births, given that the use of mediolateral or lateral episiotomy has been shown to significantly reduce the incidence of obstetrical anal sphincter injury in these groups by 43% and 68%, respectively. However, the complications associated with episiotomy including perineal pain, dyspareunia, and sexual dysfunction should be acknowledged. Despite considerable research, interventions for reducing the risk of perineal trauma remain a subject of controversy. In this review article, we present the available data on the prevention of perineal trauma by describing the risk factors associated with perineal trauma and interventions that can be implemented to prevent perineal trauma, in particular obstetrical anal sphincter injury.

The global burden of disease due to benign gynecological conditions: A call to action.

OBJECTIVE: Focusing on low- and middle-income countries (LMICs), this article uses data from the Global Burden of Disease (GBD) database to highlight the burden of morbidity due to benign gynecological conditions (BGCs). METHODS: We analyzed 2019 morbidity data for all BGCs, measured as years lost to disability (YLDs). Disease burden was calculated for individual conditions, BGCs overall, and percentages of overall disease burden from all conditions. The same data extraction was performed for malaria, tuberculosis, and HIV/AIDS for comparison. The data were subcategorized by age and World Bank income level. RESULTS: BGCs are major causes of disease morbidity worldwide. For women aged 15 years and over in high-income countries (HICs), 3 588 157 YLDs (3.94% of all YLDs) were due to BGC. In LMICs, 18 242 989 YLDs (5.35% of all YLDs) were due to BGCs. The highest burden of BGCs is seen during the reproductive years where conditions driven or exacerbated by reproductive hormones are the major causes of morbidity. In LMICs, for women aged 15-49, 14 574 100 YLDs (7.75% of all YLDs) were due to BGCs, declining to 3 152 313 YLDs (3.04%) in women aged 50-69 and 529 399 YLDs (1.06%) in women age 70+. CONCLUSION: These data demonstrate a huge burden of morbidity due to BGCs. There is an urgent need for international stakeholders to prioritize the treatment and prevention of BGCs.

UK survey of colorectal surgeons on the management of acute obstetric anal sphincter injuries.

AIM: The role of colorectal surgeons in the management of acute obstetric anal sphincter injury (OASI) is an ongoing debate. Their expertise in operating in the anorectal region lends itself to assisting in OASI repair. The aim of this study was to establish the current involvement and recommended management of acute OASI by colorectal surgeons. METHOD: An online survey of consultant colorectal surgeons was sent to members of the Pelvic Floor Society to assess current involvement in acute OASI management and repair. RESULTS: Forty completed surveys were collated and analysed. Sixty-five per cent of respondents had seen an acute OASI since being a consultant and 50% stated they were involved in the repair of OASI less than once per year. 37.5% felt that a de-functioning stoma was still necessary sometimes. Many agreed with current guidelines for OASI repair in terms of antibiotics, laxatives and follow-up. CONCLUSIONS: Colorectal surgeons have varied opinions on the management of OASI. We suggest that multidisciplinary training of obstetricians and colorectal surgeons could lead to more collaboration regarding the management of women with acute OASI.

Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial.

Background: Prolapse affects 30-40% of women. Those using a pessary for prolapse usually receive care as an outpatient. This trial determined effectiveness and cost-effectiveness of pessary self-management (SM) vs clinic-based care (CBC) in relation to condition-specific quality of life (QoL). Methods: Parallel-group, superiority randomised controlled trial, recruiting from 16 May 2018 to 7 February 2020, with follow-up to 17 September 2021. Women attending pessary clinics, ≥18 years, using a pessary (except Shelf, Gellhorn or Cube), with pessary retained ≥2 weeks were eligible. Limited manual dexterity; cognitive deficit; pregnancy; or requirement for non-English teaching were exclusions. SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received usual routine appointments. The primary clinical outcome was pelvic floor-specific QoL (PFIQ-7), and incremental net monetary benefit for cost-effectiveness, 18 months post-randomisation. Group allocation was by remote web-based application, minimised on age, user type (new/existing) and centre. Participants, intervention deliverers, researchers and the statistician were not blinded. The primary analysis was intention-to-treat based. Trial registration: https://doi.org/10.1186/ISRCTN62510577. Findings: The requisite 340 women were randomised (169 SM, 171 CBC) across 21 centres. There was not a statistically significant difference between groups in PFIQ-7 at 18 months (mean SM 32.3 vs CBC 32.5, adjusted mean difference SM-CBC -0.03, 95% CI -9.32 to 9.25). SM was less costly than CBC. The incremental net benefit of SM was £564 (SE £581, 95% CI -£576 to £1704). A lower percentage of pessary complications was reported in the SM group (mean SM 16.7% vs CBC 22.0%, adjusted mean difference -3.83%, 95% CI -6.86% to -0.81%). There was no meaningful difference in general self-efficacy. Self-managing women were more confident in self-management activities. There were no reported suspected unexpected serious adverse reactions, and 31 unrelated serious adverse events (17 SM, 14 CBC). Interpretation: Pessary self-management is cost-effective, does not improve or worsen QoL compared to CBC, and has a lower complication rate. Funding: National Institute for Health and Care Research, Health Technology Assessment Programme (16/82/01).

Diagnosis, management and training in perineal trauma: a UK national survey of obstetricians.

INTRODUCTION AND HYPOTHESIS: Perineal trauma during vaginal delivery is very common. Training in diagnosis and repair of trauma, including obstetric anal sphincter injuries, varies in the UK. We aimed to investigate the current knowledge and training received by obstetric physicians. METHODS: A national, validated survey was conducted online, using Qualtrics. The National Trainees Committee distributed the survey. It was also sent directly to consultants via email. RESULTS: A total of 302 physicians completed the survey and were included in the analysis. 3.9% of participants described their training in obstetric perineal trauma as "very poor" or "poor". 20.5% said they have not received training. 8.6% of physicians practising for more than 10 years had not had training for over 10 years. 70.5% responded "somewhat agree" or "strongly agree" when asked if they would like more training. Identification of first, second, third-, and fourth-degree tears from images and descriptions was very good (more than 80% correct for all categories). Classification of other perineal trauma was less consistent, with many incorrectly using the Sultan Classification. "Manual perineal support" and "Controlled or guided delivery" were the most frequently selected methods for the prevention of obstetric anal sphincter injury (OASI). CONCLUSIONS: Training experience for physicians in obstetric perineal trauma varies. Further improvement in training and education in perineal trauma, particularly in OASI, is needed for physicians. Perineal trauma that is not included in the Sultan Classification is often misclassified.

Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women.

BACKGROUND: Pelvic organ prolapse (POP) is the descent of a woman's uterus, bladder, or rectum into the vagina. It affects 50% of women over 50 years old who have given birth to at least one child, and recognised risk factors are older age, higher number of births, and higher body mass index. This review assesses the effects of oestrogen therapy, alone or in combination with other treatments, on POP in postmenopausal women. OBJECTIVES: To assess the benefits and harms of local and systemic oestrogen therapy in the management of pelvic organ prolapse symptoms in postmenopausal women, and to summarise the principal findings of relevant economic evaluations. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register (up to 20 June 2022), which includes CENTRAL, MEDLINE, two trials registers, and handsearching of journals and conference proceedings. We also checked the reference lists of relevant articles for additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs), quasi-RCTs, multi-arm RCTs, and cross-over RCTs that evaluated the effects of oestrogen therapy (alone or in combination with other treatments) versus placebo, no treatment, or other interventions in postmenopausal women with any grade of POP. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from the included trials using prespecified outcome measures and a piloted extraction form. The same review authors independently assessed the risk of bias of eligible trials using Cochrane's risk of bias tool. Had data allowed, we would have created summary of findings tables for our main outcome measures and assessed the certainty of the evidence using GRADE. MAIN RESULTS: We identified 14 studies including a total of 1002 women. In general, studies were at high risk of bias in terms of blinding of participants and personnel, and there were also some concerns about selective reporting. Owing to insufficient data for the outcomes of interest, we were unable to perform our planned subgroup analyses (systemic versus topical oestrogen, parous versus nulliparous women, women with versus without a uterus). No studies assessed the effects of oestrogen therapy alone versus no treatment, placebo, pelvic floor muscle training, devices such as vaginal pessaries, or surgery. However, we did identify three studies that assessed oestrogen therapy in conjunction with vaginal pessaries versus vaginal pessaries alone and 11 studies that assessed oestrogen therapy in conjunction with surgery versus surgery alone. AUTHORS' CONCLUSIONS: There was insufficient evidence from RCTs to draw any solid conclusions on the benefits or harms of oestrogen therapy for managing POP symptoms in postmenopausal women. Topical oestrogen in conjunction with pessaries was associated with fewer adverse vaginal events compared with pessaries alone, and topical oestrogen in conjunction with surgery was associated with reduced postoperative urinary tract infections compared with surgery alone; however, these findings should be interpreted with caution, as the studies that contributed data varied substantially in their design. There is a need for larger studies on the effectiveness and cost-effectiveness of oestrogen therapy, used alone or in conjunction with pelvic floor muscle training, vaginal pessaries, or surgery, for the management of POP. These studies should measure outcomes in the medium and long term.

Design and management considerations for control groups in hybrid effectiveness-implementation trials: Narrative review & case studies.

Hybrid effectiveness-implementation studies allow researchers to combine study of a clinical intervention's effectiveness with study of its implementation with the aim of accelerating the translation of evidence into practice. However, there currently exists limited guidance on how to design and manage such hybrid studies. This is particularly true for studies that include a comparison/control arm that, by design, receives less implementation support than the intervention arm. Lack of such guidance can present a challenge for researchers both in setting up but also in effectively managing participating sites in such trials. This paper uses a narrative review of the literature (Phase 1 of the research) and comparative case study of three studies (Phase 2 of the research) to identify common themes related to study design and management. Based on these, we comment and reflect on: (1) the balance that needs to be struck between fidelity to the study design and tailoring to emerging requests from participating sites as part of the research process, and (2) the modifications to the implementation strategies being evaluated. Hybrid trial teams should carefully consider the impact of design selection, trial management decisions, and any modifications to implementation processes and/or support on the delivery of a controlled evaluation. The rationale for these choices should be systematically reported to fill the gap in the literature.

Postpartum perineal wound infection and its effect on anal sphincter integrity: Results of a prospective observational study.

INTRODUCTION: Perineal wound infection can affect tissues at superficial, deep, and organ space levels. Women with obstetric anal sphincter injuries (OASIS) are at risk of infection; however, no study to date has investigated if infection can extend to affect the anal sphincter integrity. The aim of this study was to evaluate the clinical progression of perineal wound infection and its effect on the anal sphincter in women with or without OASIS using three-dimensional endoanal ultrasound (3D-EAUS). MATERIAL AND METHODS: Women were recruited into the Prospective Observational Study Evaluating the Sonographic Appearance of the Anal Sphincter in Women With Perineal Wound Infection Following Vaginal Delivery (PERINEAL Study) between August 2020 and August 2021 (NCT04480684). 3D-EAUS was performed weekly until complete wound healing. Significant bacterial colonization was diagnosed using the MolecuLight i:X camera. The primary study outcome was a change in a sphincter defect angle from baseline (wound infection) until wound healing. A robust Poisson regression model was used to analyze the effect of significant bacterial loads on the anal sphincter. RESULTS: Seventy-three women were included. A median of two ultrasound scans were performed in each patient (range 1-16). Five women (6.8%) had an OASI clinically diagnosed at delivery. In total, 250 EAUS were performed. An external anal sphincter defect was found on EAUS in 55 (22.0%) scans (n = 10 women). An external anal sphincter and internal anal sphincter defect was found in 26 scans (10.4%) (n = 3 women). During the course of the wound healing process, there was no significant change in defect size in wounds with or without significant bacterial colonization. In cases of an intact anal sphincter, wound infection did not disrupt its integrity. CONCLUSIONS: We found that perineal wound infection does not disrupt an intact anal sphincter or OASIS. This new information can provide important information for clinicians and patients. As there are myths frequently encountered in cases of litigation when disruption of sphincter integrity is attributed to perineal infection, the findings of this study should be tested in larger studies in the future.

The incidence of anal incontinence following obstetric anal sphincter injury graded using the Sultan classification: a network meta-analysis.

OBJECTIVE: This study aimed to systematically determine and compare the incidence of anal incontinence between those with different grades of obstetric anal sphincter injury. DATA SOURCES: Ovid MEDLINE, Embase, and the Cochrane Library were searched from January 2000 to April 2021. STUDY ELIGIBILITY CRITERIA: Observational studies investigating the incidence of anal incontinence following an obstetric anal sphincter injury that was graded using the Sultan classification were eligible for inclusion. To allow comparison between individual tear grades (3a, 3b, 3c, fourth), a network meta-analysis was performed using Stata (version 15.1). METHODS: For binary outcomes, odds ratios with corresponding 95% confidence intervals were reported. Obstetric anal sphincter injury grades were ranked from the best clinical outcome to the worst clinical outcome. The percentage chance of each grade taking each rank with regards to outcome was calculated. Study quality and risk of bias was assessed using the relevant tool from the Joanna Briggs Institute. RESULTS: Of the 696 studies identified, 10 were eligible for inclusion and were included in the network meta-analysis (n=2467 women). The mean incidence of anal incontinence among those with 3a tears was 22.4% (range, 6.1%-51.2%), 24.9% (range, 6.9%-46.7%) among those with 3b tears, 26.8% (range, 0%-55.6%) among those with 3c tears, and 28.6% (0%-71.4%) among those with fourth-degree tears. Anal incontinence incidence was found to be significantly higher among those with 3c (odds ratio, 1.79; 95% confidence interval, 1.09-2.94) and fourth-degree tears (odds ratio, 2.37; 95% confidence interval, 1.40-4.02) than among those with 3a tears. In addition, anal incontinence incidence was significantly higher among those with fourth-degree tears (odds ratio, 1.89; 95% confidence interval, 1.10-3.22) than among those with 3b tears. Those with 3a tears had the highest probability of having the best clinical outcome; those with 3b; second-, 3c; third- and fourth-degree tears had the highest probability of having the worst clinical outcome. Overall, all studies had a high or unclear risk of bias across 1 or more assessed element. CONCLUSION: This was a network meta-analysis comparing the incidence of anal incontinence among those with different grades of obstetric anal sphincter injury. Increasing tear-grade severity is associated with worse clinical outcomes. This study provides useful, clinically applicable information that can assist clinicians in the counseling of women following an obstetric anal sphincter injury. In addition, it highlights the importance of accurately diagnosing the obstetric anal sphincter injury grade and subsequently performing the appropriate repair.

Getting the size right: Are clinicians ready for it?

Objectives Digital examination has many uses in obstetrics and gynaecology, including cervical assessment in labour and measuring for vaginal pessaries. Clinicians must be adequately trained to perform accurate digital assessments and use this information to make decisions. We aimed to evaluate the accuracy of a clinician's estimate for three different measuring tasks and assess whether there was any difference in the accuracy in relation to seniority or job role. Study design Doctors and midwives were recruited from two perineal trauma training events. Estimates and measurements for three different activities were recorded: length of own index finger, length of an anal sphincter model and cervical dilatation at two different dilatations (7 cm and 9 cm) using a pocket guide cervical dilatation tool. The results were analysed for accuracy of measurements according to job role and seniority. Results A total of 369 participants took part. Only 4.6% of participants accurately (to 0.1 cm) estimated the length of their index finger (0% of midwives and 5.5% of doctors). There was a significant difference (p < 0.05) when comparing average differences between estimated and actual lengths measured for doctors and midwives for almost all measurements. When comparing doctors based on seniority there was no significant difference in the accuracy of estimated lengths. A higher percentage of midwives than doctors were accurate at both 7 cm (22% vs 16.1%) and 9 cm (30.5% vs 29.5%) dilated. Conclusion We found that accuracy was poor for both doctors and midwives when asked to estimate various measurements. We suggest that training will improve awareness of finger length and therefore improve accuracy when performing digital examinations in clinical practice.

Bacterial autofluorescence in infected perineal wounds: A prospective cohort study.

Diagnosis of perineal wound infection based solely on clinical signs and symptoms is subjective, and often incorrectly identifies wounds with clinically significant bacterial loads. New advances in wound care such as bacterial fluorescence imaging allow point-of -care assessment of bacterial burden. This single-center, prospective observational study included 80 women with perineal wound infection and aimed to determine the incidence of significant bacterial colonization identified with bacterial fluorescence imaging. Also, to evaluate the diagnostic accuracy of bacterial fluorescence imaging. 30 women (37.5%) had fluorescence in their wounds despite antibiotic therapy. The sensitivity of bacterial fluorescence imaging in the diagnosis of wounds with a clinically significant bacterial burden was 83% and specificity was 90%. The positive predictive value was 92% and negative predictive value was 80%. Overall, diagnostic accuracy was substantial. The results of this study demonstrate that bacterial fluorescence imaging can provide real-time information surrounding the bacterial burden of perineal wounds. ClinicalTrials.gov NCT04480684.

Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse.

BACKGROUND: Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alternative to surgery for the management of POP. However, the need for regular follow-up can be burdensome for women and requires significant healthcare resources. The TOPSY study is a randomised controlled trial which aims to determine the clinical and cost-effectiveness of self-management of vaginal pessaries. This paper describes the theoretical and practical development of the self-management intervention. METHODS: The intervention was developed using the MRC complex intervention framework, normalisation process theory (NPT) and self-management theory. The intervention aims to boost perceived self-efficacy in accordance with Bandura's social cognitive theory and is guided by the tasks and skills Lorig and Hollman describe as necessary to self-manage a health condition. RESULTS: The TOPSY intervention was designed to support women to undertake the medical management, role management and emotional management of their pessary. The six self-management skills described by Lorig and Hollman: problem-solving, decision-making, resource utilisation, formation of a patient-provider partnership role, action planning and self-tailoring, are discussed in detail, including how women were supported to achieve each task within the context of pessary self-management. The TOPSY intervention includes a self-management support session with a pessary practitioner trained in intervention delivery, a follow-up phone call 2 weeks later and ongoing telephone or face-to-face support as required by the woman initiated by contacting a member of the research team. CONCLUSIONS: The TOPSY study intervention was developed utilising the findings from a prior service development project, intervention development and self-efficacy theory, relevant literature, clinician experience and feedback from pessary using women and members of the public. In 2022, the findings of the TOPSY study will provide further evidence to inform this important aspect of pessary management. TRIAL REGISTRATION: ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017.

Can transperineal ultrasound improve the diagnosis of obstetric anal sphincter injuries?

INTRODUCTION AND HYPOTHESIS: Women with missed obstetric anal sphincter injuries (OASIs) are at an increased risk of anal incontinence. Our aim was to assess the accuracy of three-dimensional (3D) transperineal ultrasound (TPUS) compared with clinical examination for detecting OASIs. METHODS: A cross-sectional study of women undergoing their first vaginal delivery. Perineal trauma was initially assessed by the doctor or midwife performing the delivery (accoucheur) and women were then re-examined by the trained research fellow (KW). A 3D TPUS was performed immediately after delivery before suturing to identify OASIs. The research fellow's clinical diagnosis was used as the reference standard. A power calculation determined that 216 women would be required for the study. RESULTS: Two hundred and sixty-four women participated and 226 (86%) delivered vaginally. Twenty-one (9%) sustained OASIs. Six (29%) of these tears were missed by the accoucheur but were identified by the research fellow. TPUS identified 19 of the 21 (90.5%) OASIs. One percent (n = 2) had sonographic appearances of an anal sphincter defect that was not seen clinically. The positive and negative predictive value of TPUS to detect OASIs was 91% and 99% respectively. TPUS identified 91% of OASIs compared with 71% detected by the accoucheur, which was not statistically significant. CONCLUSIONS: The detection rate of OASIs with TPUS and with the clinical findings of the accoucheur was similar. Given the training and financial implications needed for TPUS, attention needs to be focused on the training of midwives and doctors to identify anal sphincter injuries by clinical examination.