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.

Understanding Factors That Affect Willingness to Self-Manage a Pessary for Pelvic Organ Prolapse: A Questionnaire-Based Cross-Sectional Study of Pessary-Using Women in the UK.

INTRODUCTION AND HYPOTHESIS: Pessary self-management offers benefits to women with no increased risk of complications. However, many are unwilling to self-manage, preferring clinician-led care. This study is aimed at exploring factors associated with willingness to self-manage a pessary. METHODS: Women attending pessary clinic at a UK hospital were asked to complete a questionnaire providing responses on pessary use, comorbidities, female genital self-image, self-management experience and willingness (or not) to learn self-management. Based upon statistical advice we aimed to recruit 90 women. Data were analysed using the non-parametric Kruskal-Wallis test and Chi-squared test. Free text data were analysed thematically. RESULTS: A total of 89 women completed the questionnaire. Thirty-three women (38%) had previously been taught pessary self-management. Of the remaining women, 12 (21%) were willing to learn, 28 (50%) were not willing and 16 (29%) were unsure. There was no correlation between female genital self-image and willingness to self-manage a pessary. Younger women were more willing to learn self-management (p = < 0.001). Willing women were motivated by reduced follow-up visits. Self-managing women reported benefits including increased autonomy, cleanliness and giving their body "a break". Reasons discouraging women from self-managing were a lack of confidence; feeling physically unable; wanting clinician-led care; fear of problems or previous problems with their pessary. CONCLUSIONS: Most women were either unsure about pessary self-management or unwilling to self-manage. Age was the only factor we found that had a significant relationship with willingness to self-manage a pessary. With robust self-management teaching, support and follow-up, it is likely that many of the barriers women report can be overcome.

A service evaluation to determine where and who delivers pessary care in the UK.

INTRODUCTION AND HYPOTHESIS: Pessaries offer effective conservative management for symptoms of pelvic organ prolapse and are frequently used in the UK. Previous publications have highlighted a lack of evidence-based pessary guidelines. There is also a dearth of evidence regarding who UK pessary practitioners are and the training received. METHODS: A Freedom of Information request was sent to 167 healthcare organisations in the UK. Requested information included the number of pessaries inserted or changed, the grade and profession of pessary practitioners and training requirements at the organisation. RESULTS: Responses were received from 128 organisations. One hundred and ten had provided information for practitioners managing pessaries. At 66% (72) of organisations, pessary care was provided by both doctors and nurses of varying grades. At 23% of organisations either solely doctors or solely nurses provided pessary care. At the remaining 9% there was a multidisciplinary approach to pessary care. At 3 hospitals, unregistered healthcare professionals provided pessary care. At the majority of organisations, respondents undertook supervised practise to gain skills in pessary management. Additional methods of training cited were learning through observation or achieving set competencies. Twenty-six percent received didactic training. At 21% of organisations there were no training requirements. CONCLUSIONS: At most organisations, there was a multidisciplinary approach to pessary care. It is questionable whether unregistered healthcare professionals should be delegated responsibility for pessary care. A standardised approach to pessary practitioner training is advocated to ensure that women receive safe, evidence-based pessary care. The UK Clinical Guidance Group for the Use of Pessaries in Vaginal Prolapse is currently developing national evidence-based guidelines to support pessary practitioners in their practice, including training requirements.

"Voice your choice": a study of women's choice of surgery for primary stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: This was an observational study aiming to determine factors which influence women's choice of surgery for primary stress urinary incontinence (SUI). METHODS: Two hundred twelve women undergoing a primary SUI procedure were recruited to this study from 12 hospitals in the north of England. After choosing a procedure, women were asked to complete a standardized semi-structured questionnaire about their health, demographics and a free text box to record factors important to them when choosing their procedure. Statistical analysis was performed to determine the impact of demographic, lifestyle or healthcare factors on women's decision-making. Thematic analysis of the free text data was performed to identify factors important for women when choosing a surgical procedure. RESULTS: Sixty-four percent of women chose urethral bulking. There was no significant difference among age, BMI, smoking status or previous laparotomy between women choosing the four types of surgery. Women were less likely to choose urethral bulking if seen in a tertiary centre compared with a secondary centre (p < 001). Major themes in decision-making were efficacy, invasiveness, recovery, risk of complications, use of mesh, the clinician, the media, hierarchy of treatments and type of anaesthetic. Some women expressed a hierarchical approach to treatment. CONCLUSIONS: Our findings suggest decision-making is not influenced by patient factors such as age, BMI, smoking status or previous laparotomies. Women's choices are a complex mix of factors and not simply related to efficacy.

Laparoscopic sacrocolpopexy posthysterectomy: intraoperative feasibility and safety in obese women compared with women of normal weight.

INTRODUCTION AND HYPOTHESIS: Our aim was to determine the intraoperative feasibility and complication rate of laparoscopic sacrocolpopexy (LSC) in overweight and obese women compared with women of normal weight. METHODS: This was a retrospective observational cohort study (Canadian Task Force classification II-2) conducted at a tertiary urogyaenocology unit evaluating 119 women who underwent LSC between March 2005 and January 2013. RESULTS: Body mass index (BMI) was classified as normal (22.89 ± 1.55), overweight (27.12 ± 1.40) and obese (33.47 ± 3.26) according to the World Health Organisation (WHO) classification. There was no difference in intraoperative complication rates for bladder, bowel, ureteric or vascular injury; haemorrhage; conversion to laparotomy; or anaesthetic complications for normal weight, overweight or obese women. Similarly there was no difference in operating time, duration of anaesthetic or hospital stay between BMI class (p = 0.070, p = 0.464, p = 0.898, respectively) postoperative or mesh complication rates. At 6-months' follow-up, there was no difference in Patient Global Impression of Improvement scale (PGI-I) (defined as very much better or much better) between normal weight, overweight and obese women (76.9, 72 and 65.4%, p = .669) or objective cure using the Pelvic Organ Prolapse Quantification (POP-Q) examination (p = 0.402). CONCLUSIONS: LSC is feasible, with equivalent intraoperative complication rates for normal weight, overweight and obese women when performed by experienced laparoscopic urogynaecologists. Given the benefits of a laparoscopic approach in obese women, the authors suggest they should be offered LSC as an option to treat vault prolapse when surgical management is being considered.

A review of pessary for prolapse practitioner training.

Pelvic organ prolapse is a significant quality of life issue for many women. Prolapse can be managed effectively with a mechanical device called a pessary therefore many women choose this as a conservative treatment option. Despite the extent to which pessaries are used in the UK, there are no clear guidelines regarding the training required for pessary practitioners. This article reviews literature related to pessary practitioner training. METHODS: 13 publications were reviewed. RESULTS: eight themes were identified, namely 'prevalence of pessary training', 'type of pessary training', confidence in pessary care provision', 'impact on pessary care', 'skills and knowledge required to be a pessary practitioner', 'barriers', 'speciality of pessary care providers', and 'ongoing support'. CONCLUSION: at present practitioners report a lack of pessary training, which impacts on care. Effective training includes didactic learning of agreed knowledge requirements, practice of clinical skills and ongoing support.

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).

What are the barriers and facilitators to self-management of chronic conditions reported by women? A systematic review.

INTRODUCTION: Pelvic organ prolapse (POP) can be effectively managed using a pessary. A scoping review found that pessary self-management appears to benefit women with no increased risk. Despite this, many are unwilling to self-manage their pessary. At present, there is a lack of understanding about what affects willingness to self-manage a pessary. However, there may be relevant, transferable findings from other literature about barriers to the self-management of other chronic conditions. Therefore, this systematic review aims to identify, appraise and synthesise the findings of published qualitative research exploring the barriers and facilitators to self-management of chronic conditions reported by women. METHODS AND ANALYSIS: The systematic review will be conducted and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and a guide for the systematic review of qualitative data. A search of MEDLINE, CINAHL, Embase and PsycInfo will be undertaken to identify relevant articles that meet the eligibility criteria using the search terms 'Women', 'Woman' 'Female,' 'Chronic', 'Long-term', 'Disease', 'Illness', 'Condition' 'Health,' 'Self-management,' 'Qualitative,' 'Barrier' and 'Facilitator'. A hand search of the reference list of non-original research identified during the search but excluded will be conducted for additional publications, which meet the inclusion and exclusion criteria. Studies published before 2005 and those not available in English will be excluded. Data relevant to the topic will be extracted and critical appraisal of all included publications undertaken. ETHICS AND DISSEMINATION: No ethical or Health Research Authority approval is required to undertake the systematic review. The systematic review findings will be disseminated by publication. The findings will also inform subsequent exploratory work regarding pessary self-management. PROSPERO REGISTRATION NUMBER: CRD42022327643.

What is known from the existing literature about self-management of pessaries for pelvic organ prolapse? A scoping review protocol.

INTRODUCTION: Pelvic organ prolapse (POP) can be managed with a pessary; however, regular follow-up may deter women from pessary management due to the inconvenience of frequent appointments, as well as preventing pessary users from autonomous decision-making. Pessary self-management, whereby the woman removes and inserts her own pessary may be a solution to these issues. However, there remains a number of uncertainties regarding the potential benefits and risks of pessary self-management. This scoping review aims to map available evidence about the subject of pessary self-management for POP to identify knowledge gaps providing the basis for future research. METHODS AND ANALYSIS: The scoping review will be conducted using the Joanna Briggs Institute scoping review methodology and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A search of Medline, CINAHL, Embase and PsycInfo will be undertaken to identify relevant articles which meet the eligibility criteria using the search terms 'pessary' and 'self-management' or 'self-care'. A hand search of the reference list of non-original research identified during the search but excluded, will be conducted for additional publications which meet the inclusion and exclusion criteria. Data relevant to the topic of pessary self-management will be extracted and critical appraisal of all included publications undertaken. ETHICS AND DISSEMINATION: No ethical or Health Research Authority approval is required to undertake the scoping review. However, it has been registered with The Open Science Framework (DOI 10.17605/OSF.IO/DNGCP). The findings will inform future research exploring pessary self-management and be disseminated via both a presentation at a national conference and publications in peer reviewed journals.

What is known from the existing literature about self-management of pessaries for pelvic organ prolapse? A scoping review.

OBJECTIVES: Pelvic organ prolapse can be managed with a pessary. However, regular follow-up may deter women due to the inconvenience of frequent appointments, as well as preventing autonomous decision making. Pessary self-management may be a solution to these issues. However, there remains a number of uncertainties regarding pessary self-management. This scoping review aims to map available evidence about pessary self-management to identify knowledge gaps providing the basis for future research. DESIGN: Scoping review as detailed in the review protocol. DATA SOURCES: A search of MEDLINE, CINAHL, EMBASE and PsycINFO databases and a handsearch were undertaken during May 2021 to identify relevant articles using the search terms 'pessary' and 'self-management' or 'self-care'. DATA EXTRACTION AND SYNTHESIS: Data relevant to pessary self-management was extracted and the Mixed Methods Appraisal Tool used to assess empirical rigour. Thematic analysis was performed to evaluate the results. RESULTS: The database search identified 82 publications. After duplicates and articles not meeting the inclusion and exclusion criteria were removed, there were 23 eligible articles. A hand search revealed a further 19 articles, resulting in a total of 42 publications.Findings relevant to pessary self-management were extracted and analysed for the emergence of themes. Recurrent themes in the literature were; the characteristics of self-managing women; pessary care; factors associated with decision making about self-management; teaching self-management and cost benefit. CONCLUSIONS: Pessary self-management may offer benefits to some women without increased risk. Some women do not feel willing or able to self-manage their pessary. However, increased support may help women overcome this. Further in-depth exploration of factors which affect women's willingness to self-manage their pessary is indicated to ensure better understanding and support as available for other conditions.

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.

Laparoscopic sacrocolpopexy (LSCP) using an ultra-lightweight polypropylene mesh.

OBJECTIVES: Since 2005 the preferred method for surgical treatment of vaginal vault prolapse within the department has been laparoscopic sacrocolpopexy with an ultra-lightweight polypropylene mesh. The study aimed to explore the functional and anatomical outcomes and mesh adverse events of women following this procedure. STUDY DESIGN: All women who had a Laparoscopic Sacrocolpopexy (LSCP) using an ultra-lightweight (19 g/m2) polypropylene mesh in two units in the North West of England between March 2005 and January 2013 (n = 238) were invited to participate in the study.Functional outcome data was collected using the Patient Global Impression Questionnaire (PGI-I), the Pelvic Floor Distress Inventory (PFDI-20) and the Electronic Personal Assessment Questionnaire (EPAQ) post-operatively. Anatomical outcome was assessed by Pelvic Organ Prolapse Quantification System (POP-Q) measurement. A mesh palpability assessment was performed and any mesh complications were recorded using the International Continence Society/International Urogynecology Association (ICS/IUGA) classification system. The results were compared to those in our previously published series using the same surgical technique but a standard weight mesh (82.5 g/m2). RESULTS: 89% of participants reported that they felt their post-operative condition had improved. POP-Q results revealed that the median position of C changed from -3 pre-op to -7 post-operatively. Mesh was palpable during vaginal examination in only 3 women (3%). No mesh extrusion was identified during the study. CONCLUSIONS: The study demonstrates that LSCP performed with an ultra-lightweight polypropylene mesh improves women's functional and anatomical symptoms and appears to have a low risk of mesh extrusion.