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.

Patient experience of pain during vaginal pessary removal and insertion: a service evaluation study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse is a common problem affecting women, but there is currently a lack of research focusing on patient experience of pessary changes. This study was aimed at capturing the patient perspective of pessary changes and formally assessing pain during pessary removal and insertion. METHODS: A service evaluation request was granted by South Tees Hospitals NHS Trust. Patients undergoing pessary change (ring, shelf, or Gellhorn) in gynaecology outpatient clinics over a 6-month period were asked to rate their pain scores on a ten-point numerical pain-rating scale. Other associated data were collected. RESULTS: Out of 213 women, 58.2% reported that pessary removal was more painful than insertion, 30.5% reported equal pain, and 10.8% reported that insertion was more painful than removal. Pain scores were significantly higher for removal (mean 4.37, median 4, IQR 4-7) than for insertion (mean 2.66, median 2, IQR 2-4, p <0.001). Ring pessaries were significantly less painful to both remove and insert than shelf and Gellhorn pessaries. Smaller pessaries were more painful to both remove and insert. There was no significant difference in pain scores reported by those with or without diagnosed vulval conditions. CONCLUSIONS: Pessary removal causes most women moderate pain, which should be communicated to patients beforehand. Ring pessaries are significantly less painful to change than other pessary types. Clinicians should consider pain as a factor in their decision-making surrounding pessary choice and when counselling patients. Future research should focus on ways to reduce pain during pessary removal.

Impact of intravesical onabotulinumtoxinA (Botox) on sexual function in patients with overactive bladder syndrome: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: The association between overactive bladder (OAB) syndrome and sexual dysfunction is well documented. Intra-detrusor onabotulinumtoxinA (Botox) has proven to be effective treatment for OAB syndrome. Our aim was to examine the impact of intravesical Botox injection on sexual function in patients with OAB, by systematically reviewing the literature. METHODS: We reviewed the literature for studies that reported a change in sexual function after Botox treatment in patients suffering from OAB. This review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement using pre-agreed keywords, from database inception to December 2020. Statistical analyses were performed using Review Manager (RevMan; v.5.4). RESULTS: Initial results yielded 455 citations. Seven articles met our inclusion criteria. One article was double-reported, leaving 6 studies in the systematic review. Three observational before-and-after studies used the Female Sexual Function Index (FSFI) with sufficient information, and therefore were included in our meta-analysis. The pooled number of participants in all studies was 119 patients. In the meta-analysis, there was significant improvement in the following domains of the FSFI after Botox injection; desire (mean difference (MD) -0.51, p = 0.02), arousal (MD -0.86, p = 0.02), lubrication (MD -0.57, p = 0.03), orgasm (MD -0.65, p = 0.0003) and satisfaction (MD -0.46, p = 0.05). Pain was the only domain that did not show improvement (MD -0.07, p = 0.79). The total FSFI score was reported in 88 patients (two studies) showing significant improvement (MD -0.77, p = 0.006). CONCLUSIONS: We report a systematic review of the effect of Botox treatment on sexual function in patients with OAB. Although studies are small, the results indicate a positive effect in patients with OAB.

The effect of advisory documents on mid-urethral sling case acquisition to the British Society Urogynaecology (BSUG) database in England.

INTRODUCTION AND HYPOTHESIS: Many advisory documents have recommended uploading of all mid-urethral sling (MUS) cases onto the British Society of Urogynaecology (BSUG) or British Association of Urological Surgeons (BAUS) database. The aim of this study was to determine whether these documents have resulted in an increase in database case acquisition for MUS surgery. METHOD: We determined the number of cases uploaded onto the BSUG and BAUS databases and cases acquired by Hospital Episode Statistics (HES) over the period January 2011-March 2017 for the 6 months prior to each document and 6 months afterwards. RESULTS: There was an upsurge in data acquisition in 2013, which then declined after year end. There was a significant upsurge in case acquisition associated with the following documents: NHS Medical Director letter (p < 0.00001), the Healthcare Quality Improvement Partnership (HQIP) audit (p < 0.00001). There was a significant drop in case acquisition following the end of the HQIP audit (p < 0.00001) and the Mesh Working Group Interim report (p = 0.00325). CONCLUSION: There was a significant increase in case acquisition with the HQIP audit and decline after it. The significant increase in case acquisition seen after the NHS MD letter in November 2012 may have been due to an overlap in the data capture between it and the HQIP audit. The levels of case acquisition do not compare to registries that are essentially compulsory and therefore we believe that voluntary databases are not effective for device post-market surveillance.

Prevalence of histological abnormalities in hysterectomy specimens performed for prolapse. A systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: The practice of histopathological assessment of the uterus following hysterectomy for benign indications including pelvic organ prolapse (POP) surgery is common and often routine. While pathology is not anticipated, the finding of pathology requiring further action is always a concern, in particular CIN (cervical intraepithelial neoplasia) or cervical/uterine malignancy. We aimed to perform a systematic review to understand the prevalence of actionable uterine and cervical pathology in hysterectomy specimens performed for POP. METHODS: A literature search was performed in January 2020 of MEDLINE, Embase and CINAHL using the Healthcare Databases Advanced Search platform. Included studies reported CIN and/or uterine/cervical malignancy in histological assessment of hysterectomy specimens performed purely for POP. Meta-analysis of prevalence was performed using the MetaXL ( www.epigear.com ) add-in for Microsoft Excel. RESULTS: Six hundred seventy-seven records were identified, out of which 34 studies were eligible. Overall prevalence (95% confidence interval [CI]) of endometrial cancer in 33 studies was 0.004 (0.003-0.006), I2 = 41%, number needed to treat (NNT) 1:250. Total actionable uterine pathology was 0.005 (0.003-0.006) in 33 studies, I2 = 35%, NNT = 1:200. Overall prevalence of cervical cancer in 19 papers was 0.001 (0.000-0.002), I2 = 18%, NNT = 1:1000. In 16 studies the overall prevalence of CIN was 0.013 (0.001-0.033), I2 = 95%, NNT = 1:77. Prevalence of total actionable pathology was 0.013 (0.006-0.0023), I2 = 86%, NNT = 1:77. CONCLUSION: The risk of actionable pathology is low, but not negligible. The variation between populations is wide. The prevalence of finding such pathology supports the routine practice of sending all hysterectomy specimens performed for POP for histological assessment.

Episcissors-60™ and obstetrics anal sphincter injury: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: The National Health Service (NHS) in England has chosen the Episcissors-60™ as one of the products included in the NHS Innovation Accelerator programme. However, the evidence for its effectiveness is scanty. We therefore set out to systematically review the literature to compare risk of obstetric anal sphincter injury (OASI) in women who had undergone episiotomy with Episcissors-60™ versus those who had an episiotomy with other scissors. METHODS: Electronic search was performed on the Healthcare Databases Advanced Search (HDAS) platform using the MEDLINE, EMBASE and CINHAL search engines up to September 2018. The search words used were 'Episcissors-60' or 'episcissors 60.' Studies were included if patients who had episiotomies with Episcissors-60™ were compared with parallel or historic patients who had episiotomy with other scissors. The only restriction used was "human" studies. RESULTS: Of the initial 21 citations, 4 studies had enough information to be included in the meta-analysis. The number of study participants ranged from 63 to 4314. When comparing 797 patients who had episiotomies with Episcissors-60™ to 1122 patients who had episiotomies with other scissors, there was a significant reduction in OASI: risk difference = -0.04 (95% CI = -0.07 to -0.01; p = 0.005, I2 = 41%). The number needed to treat was 25 (95% CI = 14-100). This was not associated with an increase in episiotomy rate. CONCLUSIONS: We reported the first systematic review on the effect of Episcissors-60™ on OASI rate. Although the studies are few, and of small size and low quality, the results are promising in terms of possible reduction in OASI.

Outcome of surgical management for midurethral sling complications: a multicentre retrospective cohort study.

INTRODUCTION AND HYPOTHESIS: Suspension of midurethral sling (MUS) surgery in the UK has led to a call for further evidence regarding long-term morbidity and the efficacy of treatments when mesh complications are encountered. We reviewed how many patients who underwent MUS surgery in Teesside, UK, returned to theatre due to a complication and what the outcomes were following this surgical intervention. METHODS: All patients coded to have undergone an MUS procedure between 1 January 2010 and 31 December 2014 in Teesside were reviewed retrospectively (n = 924). Case notes were analysed for patients who returned to theatre up until December 2017 due to complications related to their original MUS. RESULTS: Seventy-one of 924 (7.7%) women returned to theatre for some form of surgical intervention. There was a statistically significant difference in return-to-theatre rate between the transobturator and retropubic approach groups (63/661; 9.5%; confidence interval (CI) 7.3-11.8% v 8/263; 3.0%; CI 0.96%, 5.1%, odds ratio (OR) 3.35, p = 0.001); 2.8% (26/924) underwent shortening, reburying, incision or MUS excision; 1.0% (9/924) underwent steroid injection along the MUS tract; 1.7% (16/924) underwent surgical treatment of detrusor overactivity; 3.0% (28/924) required further stress incontinence surgery. The risk of unresolved chronic pain post-MUS surgery following treatment of complications was 0.2% (2/924). CONCLUSIONS: Our results show a reassuringly low rate of mesh removal following MUS surgery. Furthermore, outcomes were good following surgical management of MUS complications. We advocate compulsory registration of all MUS procedures, follow-up data and complications to provide robust long-term evidence for the future.

Sacral neuromodulation and sexual function: a systematic review and meta-analysis of the literature.

INTRODUCTION AND HYPOTHESIS: Sexual function is being increasingly recognized as an important patient-reported outcome. Sacral neuromodulation (SNM) is a treatment with an expanding list of indications. The effect of sacral neuromodulation on sexual function has been examined in a number of studies with variable results. In this review, we aim to systematically review the literature and pool the data if appropriate. METHODS: The literature search was conducted primarily on the Healthcare Databases Advanced Search (HDAS) platform using the Medline, EMBASE and CINHAL search engines. Of 196 initial citations, 17 articles met our predefined inclusion criteria. Thirteen studies reported enough information to be included in our meta-analysis. RevMan5 software was used for analysis. RESULTS: Eight of 17 studies reported a positive effect of SNM on sexual function. Pooled analysis of data from 11 studies involving 573 patients before SNM and 438 patients after SNM showed significant improvement in sexual function (SMD = -0.39; 95% CI: -0.58 to -0.19; p = 0.0001). The results remained significant in most subgroup analyses except in patients suffering from fecal incontinence. CONCLUSIONS: SNM in women with pelvic floor disorders, especially bladder dysfunction, seems to have a positive effect on sexual function. This needs to be verified in adequately powered primary research using sexual function as the primary outcome.

The effect of percutaneous tibial nerve stimulation (PTNS) on sexual function: a systematic review and meta-analysis.

INTRODUCTION: Percutaneous tibial nerve stimulation (PTNS) is now an established treatment of pelvic floor dysfunction such as overactive bladder, faecal incontinence or voiding dysfunction. Prevalence of female sexual dysfunction is high in this group. We aim to examine the effect of PTNS on sexual function in this patient group by systematically reviewing the literature and pooling the data in a meta-analysis. METHODS: The literature search was conducted using the MEDLINE, Embase and CINAHL databases. Initial results yielded 74 citations. From these, nine articles met our inclusion criteria. Two articles were doubly reported, leaving seven studies in the systematic review. Only four studies reported sufficient information to be included in our meta-analysis. RESULTS: Three studies were randomised controlled trials, and five were before-after studies. The number of participants in each study ranged from 11 to 220. Four out of seven studies reported a positive effect of PTNS on sexual function. In the meta-analysis of four studies there was a significant improvement in general sexual function with PTNS (p = 0.04, SMD -0.41, CI[-0.79, -0.03], I2 = 0%). In a subgroup analysis of the bowel domain of sexual function, there was a significant improvement with PTNS (p = 0.03, MD 17.7, CI [1.92, 33.47], I2 = 0%). CONCLUSION: We report a systematic review on the effect of PTNS on sexual function. Although the studies are of small size, the results are promising in terms of a positive effect of PTNS on sexual function, and we recommend further research in this area.

One normal void and residual following MUS surgery is all that is necessary in most patients.

INTRODUCTION AND HYPOTHESIS: There is considerable variation worldwide on how the assessment of voiding function is performed following midurethral sling (MUS) surgery. There is potentially a financial cost, and reduction in efficiency when patient discharge is delayed. Using our current practice of two normal void and residual (V&R) readings before discharge, the aim of this retrospective study was to evaluate the likelihood of an abnormal second V&R test if the first V&R test was normal in order to determine if a policy of discharge after only one satisfactory V&R test is reasonable. METHODS: Data from 400 patients who had had MUS surgery with or without other procedures were collected. Our unit protocol included two consecutive voids of greater than 200 ml with residuals less than 150 ml before discharge. The patients were divided into the following groups: MUS only, MUS plus anterior colporrhaphy (AR) plus any other procedures (MUS/AR), and MUS with any non-AR procedures (MUS+). RESULTS: Complete datasets were available for 335 patients. Once inadequate tests (low volume voids <200 ml) had been excluded (28% overall), the likelihood of an abnormal second V&R test if the first test was normal was 7.1% overall, but 3.6% for MUS, 11.5% for MUS/AR and 8.6% for MUS+. CONCLUSION: The findings in the MUS-only group indicate that it is probably safe to discharge patients after one satisfactory V&R test, as long as safety measures such as 'open access' are available so that patients have unhindered readmission if problems arise.

Martius graft for TOT extrusion: a case series.

INTRODUCTION: The management of mid-urethral tape extrusion is inconsistent. We believe that we present here the first case series detailing the use of the Martius graft for trans-obturator tape (TOT) extrusion. METHODS: Five women had a Martius graft for TOT extrusion. Data were obtained retrospectively from case notes and a review postoperatively to investigate the results in the short and intermediate term. RESULTS: All extrusions were greater than 1 cm in diameter and situated between the midline and the lateral vaginal sulcus. In 3 women the tape extrusion was discovered at 6-12 weeks postoperatively and 2 presented with symptoms again after 12 months. Following the Martius graft, there was no ipsilateral recurrence of tape extrusion or exposure. Postoperatively, 2 women received oral antibiotics. Two women developed de novo sexual problems, which had resolved at follow-up. CONCLUSIONS: It is promising that all the tape extrusions were successfully treated with a Martius Graft, thus preserving tape function. There was a high incidence of minor complications initially, but there was minimal long-term morbidity and no cosmetic dissatisfaction. We believe that testing this proposition in a larger case series will provide better evidence.

Methotrexate treatment for peritoneal trophoblastic implants after laparoscopic salpingectomy and secondary laparoscopic excision of ectopic pregnancy.

Ectopic pregnancy is a one of the primary causes of maternal mortality in first trimester. The most common site of ectopic pregnancy is the fallopian tube. Surgical management of tubal ectopic pregnancy includes salpingotomy or salpingectomy. Persistent ectopic pregnancy can happen after salpingotomy due to incomplete removal of ectopic tissue. However, it is very rare after salpingectomy. In our case, the patient had right-sided salpingectomy and histology confirmed right-sided tubal ectopic pregnancy. She presented 19 days' later with abdominal pain, haemoperitoneum and persistent high beta-HCG (B-HCG). A second laparoscopy was done and tissue implants were removed from the surface of the right ovary and the omentum, which were confirmed to be products of conception on histology. The pain settled postoperative. However, B-HCG remained high postoperative. Subsequently, methotrexate treatment was given leading to full resolution of the pregnancy with one dose.

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.

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).

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.

The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation.

BACKGROUND: Process evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to the intervention and provide valuable insights into what is effective in a practical setting by examining the context in which interventions are implemented. The TOPSY study consists of a large multi-centre randomised controlled trial comparing the effectiveness of pessary self-management with clinic-based care in improving women's condition-specific quality of life, and a nested process evaluation. The process evaluation aims to examine and maximise recruitment to the trial, describe intervention fidelity and explore participants' and healthcare professionals' experiences. METHODS: The trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixed-methods approach. Semi-structured interviews will be conducted with randomised women (18 per randomised group/n = 36), women who declined trial participation but agreed to interview (non-randomised women) (n = 20) and healthcare professionals recruiting to the trial (n ~ 17) and delivering self-management and clinic-based care (n ~ 17). The six internal pilot centres will be asked to record two to three recruitment discussions each (total n = 12-18). All participating centres will be asked to record one or two self-management teaching appointments (n = 30) and self-management 2-week follow-up telephone calls (n = 30). Process data (quantitative and qualitative) will be gathered in participant completed trial questionnaires. Interviews will be analysed thematically and recordings using an analytic grid to identify fidelity to the intervention. Quantitative analysis will be predefined within the process evaluation analysis plan. DISCUSSION: The wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented. Understanding this contextual variance is central to understanding how and in what circumstances pessary self-management can be implemented (should it be effective). The inclusion of non-randomised women provides an innovative way of collecting indispensable information about eligible women who decline trial participation, allowing broader contextualisation and considerations of generalisability of trial findings. Methodological insights from examination of recruitment processes and mechanisms have the potential to inform recruitment mechanisms and future recruitment strategies and study designs. TRIAL REGISTRATION: ISRCTN62510577 . Registered on 6 October 2017.

Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial.

BACKGROUND: Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic-based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every 6 months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re-insert their pessary themselves; this is called self-management. This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care. METHODS: This is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support. The control group will receive the clinic-based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition-specific quality of life at 18 months' post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months' post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. DISCUSSION: The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic-based care in terms of improving women's quality of life, and of its cost-effectiveness. TRIAL REGISTRATION: ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017.

Obstetric anal sphincter injuries before and after the introduction of the Episcissors-60: A multi-centre time series analysis.

OBJECTIVE: To investigate the impact of the Episcissors-60 on obstetric anal sphincter injury (OASI) rates. STUDY DESIGN: Observational multi-centre time series analysis at four maternity units in the North-East of England. The main outcome measures were obstetric anal sphincter injury rates and delivery blood loss. RESULTS: Data were analysed for women who had a vaginal birth of a singleton pregnancy before (11,192) and after (8064) the introduction of the Episcissors-60. There were 2115 episiotomies before and 1498 after the introduction of the Episcissors-60, of which 1311 (87.5%) were undertaken with the Episcissors-60, 114 (7.6%) with other scissors and the scissors used were not stated in 73 (4.8%) women. There was no significant association between the introduction of Episcissors-60 and the performance of an episiotomy (χ2 = 0.006, p  = 0.94). Episiotomy was associated with a significant reduction in OASI rates (1.9% Vs 2.8%, odds ratio = 0.67 [0.51 - 0.86]; p =  0.001). There was no significant association between the introduction of the Episcissors-60 and the occurrence of OASIs in all women (χ2 = 0.6, p =  0.46) or in women who had an episiotomy (χ2 = 0.20, p = 0.71). In women who had an episiotomy, the mean estimated delivery blood loss was 550.3 ±â€¯8.2 ml before and 598.8 ±â€¯10.9 ml after the introduction of the Episcissors-60 (p <  0.001). CONCLUSION: Introduction of the Episcissors-60 was not associated with a change in OASI or episiotomy rates but may be associated with a small increase in delivery blood loss.

Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT.

BACKGROUND: Sepsis is a leading cause of direct and indirect maternal death in both the UK and globally. All forms of operative delivery are associated with an increased risk of sepsis, and the National Institute for Health and Care Excellence's guidance recommends the use of prophylactic antibiotics at all caesarean deliveries, based on substantial randomised controlled trial evidence of clinical effectiveness. A Cochrane review, updated in 2017 (Liabsuetrakul T, Choobun T, Peeyananjarassri K, Islam QM. Antibiotic prophylaxis for operative vaginal delivery. Cochrane Database Syst Rev 2017;8:CD004455), identified only one small previous trial of prophylactic antibiotics following operative vaginal birth (forceps or ventouse/vacuum extraction) and, given the small study size and extreme result, suggested that further robust evidence is needed. OBJECTIVES: To investigate whether or not a single dose of prophylactic antibiotic following operative vaginal birth is clinically effective for preventing confirmed or presumed maternal infection, and to investigate the associated impact on health-care costs. DESIGN: A multicentre, randomised, blinded, placebo-controlled trial. SETTING: Twenty-seven maternity units in the UK. PARTICIPANTS: Women who had an operative vaginal birth at ≥ 36 weeks' gestation, who were not known to be allergic to penicillin or constituents of co-amoxiclav and who had no indication for ongoing antibiotics. INTERVENTIONS: A single dose of intravenous co-amoxiclav (1 g of amoxicillin/200 mg of clavulanic acid) or placebo (sterile saline) allocated through sealed, sequentially numbered, indistinguishable packs. MAIN OUTCOME MEASURES: Primary outcome - confirmed or suspected infection within 6 weeks of giving birth. Secondary outcomes - severe sepsis, perineal wound infection, perineal pain, use of pain relief, hospital bed stay, hospital/general practitioner visits, need for additional perineal care, dyspareunia, ability to sit comfortably to feed the baby, maternal general health, breastfeeding, wound breakdown, occurrence of anaphylaxis and health-care costs. RESULTS: Between March 2016 and June 2018, 3427 women were randomised: 1719 to the antibiotic arm and 1708 to the placebo arm. Seven women withdrew, leaving 1715 women in the antibiotic arm and 1705 in the placebo arm for analysis. Primary outcome data were available for 3225 out of 3420 women (94.3%). Women randomised to the antibiotic arm were significantly less likely to have confirmed or suspected infection within 6 weeks of giving birth (180/1619, 11%) than women randomised to the placebo arm (306/1606, 19%) (relative risk 0.58, 95% confidence interval 0.49 to 0.69). Three serious adverse events were reported: one in the placebo arm and two in the antibiotic arm (one was thought to be causally related to the intervention). LIMITATIONS: The follow-up rate achieved for most secondary outcomes was 76%. CONCLUSIONS: This trial has shown clear evidence of benefit of a single intravenous dose of prophylactic co-amoxiclav after operative vaginal birth. These results may lead to reconsideration of official policy/guidance. Further analysis of the mechanism of action of this single dose of antibiotic is needed to investigate whether earlier, pre-delivery or repeated administration could be more effective. Until these analyses are completed, there is no indication for administration of more than a single dose of prophylactic antibiotic, or for pre-delivery administration. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11166984. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 54. See the National Institute for Health Research Journals Library website for further project information.

Maternal infection is a common problem after women have had a baby with the assistance of forceps or ventouse (vacuum/suction cup). We estimate that up to 1 in 10 women will have an infection around their birth canal, and almost 1 in 20 may have a more severe infection, such as an infection in the bloodstream (sepsis). A single dose of antibiotics at the time of giving birth has been shown to be effective in preventing maternal infection after caesarean birth. The aim of this trial was to investigate whether or not a single dose of preventative antibiotics was similarly effective at preventing maternal infection after giving birth with the assistance of forceps or ventouse. Women who were giving birth at > 36 weeks of pregnancy with the assistance of forceps or ventouse were randomly allocated (i.e. by chance, like tossing a coin) to receive an injection of antibiotics into a vein (intravenous) or an injection of salt solution without any antibiotics after their baby was born. Around 11 in 100 new mothers who received antibiotics had an infection within 6 weeks of delivery, compared with 19 out of 100 who did not receive antibiotics. Women receiving antibiotics also reported better healing and less discomfort from the wounds around the birth canal [either from tears or from the cut (episiotomy) used to help delivery] at 6 weeks after giving birth, and had fewer outpatient or general practitioner visits because of concerns about the wounds around the birth canal. This trial, therefore, showed that a single dose of antibiotics was very effective at preventing maternal infection after giving birth with the assistance of forceps or ventouse, as well as leading to better healing and less pain, and suggests that a single dose of antibiotics could become part of normal care.