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.

Caesarean section and anal incontinence in women after obstetric anal sphincter injury: A systematic review and meta-analysis.

BACKGROUND: Approximately 50% women who give birth after obstetric anal sphincter injury (OASI) develop anal incontinence (AI) over their lifetime. OBJECTIVE: To evaluate current evidence for a protective benefit of planned caesarean section (CS) to prevent AI after OASI. SEARCH STRATEGY: MEDLINE/PubMed, Embase 1974-2024, CINAHL and Cochrane to 7 February 2024 (PROSPERO CRD42022372442). SELECTION CRITERIA: All studies reporting outcomes after OASI and a subsequent birth, by any mode. DATA COLLECTION AND ANALYSIS: Eighty-six of 2646 screened studies met inclusion criteria, with nine studies suitable to meta-analyse the primary outcome of 'adjusted AI' after OASI and subsequent birth. Subgroups: short-term AI, long-term AI, AI in asymptomatic women. SECONDARY OUTCOMES: total AI, quality of life, satisfaction/regret, solid/liquid/flatal incontinence, faecal urgency, AI in women with and without subsequent birth, change in AI pre- to post- subsequent birth. MAIN RESULTS: There was no evidence of a difference in adjusted AI after subsequent vaginal birth compared with CS after OASI across all time periods (OR = 0.92, 95% CI 0.72-1.20; 9 studies, 2104 participants, I2 = 0% p = 0.58), for subgroup analyses or secondary outcomes. There was no evidence of a difference in AI in women with or without subsequent birth (OR = 1.00 95% CI 0.65-1.54; 10 studies, 970 participants, I2 = 35% p = 0.99), or pre- to post- subsequent birth (OR = 0.79 95% CI 0.51-1.25; 13 studies, 5496 participants, I2 = 73% p = 0.31). CONCLUSIONS: Due to low evidence quality, we are unable to determine whether planned caesarean is protective against AI after OASI. Higher quality evidence is required to guide personalised decision-making for asymptomatic women and to determine the effect of subsequent birth mode on long-term AI outcomes.

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.

Clinical outcomes after total excision of transobturator tape inserted for treatment of stress urinary incontinence.

INTRODUCTION: Midurethral tapes (MUTs) were the most common surgical treatment for stress urinary incontinence (SUI) between 2008 and 2017. Transobturator tapes were introduced as a novel way to insert MUTs. Some women have experienced life-changing complications, and opt to undergo a total excision of transobturator tape (TETOT). There is a paucity in evidence about the outcomes of TETOT, which is a complex operation. This study aims to report clinical outcomes of all women who underwent TETOT in a specialist mesh center. METHODS: All women between 2017 and 2022 who underwent TETOT in one mesh center were reviewed. Background demographics and preoperative symptoms were recorded retrospectively. Outcome data were collected using patient global impression of improvement (PGI-I) scales via telephone review and analyzed using SPSS 25. RESULTS: Forty-five women underwent telephone review in May 2022, on average 27.9 months (range: 3-60) after TETOT. Mean age was 55 and body mass index (BMI): 30; 82% were postmenopausal, 20% were smokers, and 73.3% had recurrent SUI before excision. Indications for excision were infection (4%), vaginal exposure (24%), urethral perforation (9%), and chronic pain not associated with other complications (60%). Two women with recurrent SUI opted for a concomitant fascial sling; both reported a PGI of "very much improved" regarding SUI postoperatively. Only 12 women (26.5%) did not have SUI before excision; of these 9 (75%) reported new SUI postoperatively. Pain improved for 57.8%, but worsened for 24.4%. Although not statistically significant (p = 0.055), more women who underwent TETOT for pain alone reported worsening pain than those with pain with an additional complication (37% vs. 5.55%). Overall, 62.2% women felt "better" after their excision, 17.8% felt "worse." DISCUSSION: After TETOT, 62% of women felt better. Improvement in pain was reported by 58%-those with chronic pain without another complication reported improvement in pain less frequently (48% vs. 72%) and worsening pain more frequently (37% vs. 6%). Existing SUI worsened in 65% of women and 75% developed new SUI. There appears to be discordance between reporting global improvement with worsening of commonly measured clinical outcomes. CONCLUSION: Outcome data are important for counseling women about the risks and benefits of TETOT. Women and clinicians may have different attitudes to the possible benefits of TETOT, as evidenced by women reporting feeling better despite continuing pain or SUI. Conventional outcome measures do not adequately capture all outcomes that are important to patients.

Which parameters, related to the female urethra and pelvic floor, determine therapy selection for recurrent female stress urinary incontinence: ICI-RS 2023?

INTRODUCTION: The evidence basis for therapy selection in women who have failed primary stress urinary incontinence (SUI) surgery is limited. The ICI-RS group discussed the available data at its meeting in June 2023, particularly the anatomical characteristics as assessed using magnetic resonance imaging (MRI) and ultrasound (US) modalities, functional characteristics associated with storage and voiding urodynamic assessment, as well as the patient characteristics that might influence outcomes. This paper summarizes the evidence base that supported these discussions and offers the basis for research proposals for future groups. METHODS: A literature search of MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials was performed, and the data is presented. Research questions are based on the knowledge gaps highlighted. RESULTS: Possible MRI parameters that may influence outcomes were striated urethral sphincter volume, bladder and proximal urethral funneling, pubo-urethral ligament integrity, distance of the bladder neck below the pubococcygeal line, posterior urethra-vesical angle, and bladder neck to levator ani distance. US parameters included sling distance to the urethral lumen and pubis, sling position, bladder neck mobility, and lateral arm asymmetry, twisting, or curling. Urodynamic parameters included detrusor overactivity, Valsalva leak point pressure, maximum urethral closure pressure, and bladder outlet obstruction. Important patient parameters included body mass index, age, and previous interventions. CONCLUSIONS: Identifying and quantifying causative factors in patients with recurrent SUI, that allow clinicians to modify subsequent treatment choices and techniques may help reduce treatment failure and complications. Formulating algorithms is the next step in optimizing patient counseling, surgical selection, and healthcare allocation.

Comparison of two questionnaires to diagnose obstructive defecation syndrome during pregnancy and post-natally.

INTRODUCTION AND HYPOTHESIS: Obstructive defecation syndrome (ODS) is a common urogynaecology presentation. This study compares two questionnaires, the electronic Personal Assessment Questionnaire (e-PAQ), used in urogynaecology clinics, with the ODS-Score (ODS-S), a simple validated scoring system used in colorectal clinics for diagnosing ODS, to identify patients with an ODS-S cut-off ≥9. METHODS: A total of 221 paired ODS-S and e-PAQ questionnaires were completed; 80 during the second trimester of pregnancy, 73 during the third and 68 post-natally, including women sustaining obstetric anal sphincter injury (OASI). e-PAQ score and ODS-S were compared and Pearson's correlation coefficient calculated. Areas under the curve assessed the diagnostic ability of e-PAQ scores to identify patients with ODS-S of ≥9. RESULTS: The e-PAQ and ODS-S scores showed a positive correlation in the second and third trimesters of pregnancy, post-natally and following OASI. Pearson's correlation coefficient was calculated (0.77; p < 0.001, 0.79; p < 0.001, 0.66; p = 0.001 and 0.79; p < 0.001 respectively). An e-PAQ evacuatory domain score of ≥33 identified women with an ODS score of ≥9 with a sensitivity and specificity of 71% and 94% in the second trimester, 86% and 95% third trimester and 78% and 97% in the OASI group respectively. Area under the curve was >0.90 for all groups. CONCLUSIONS: Comparison of e-PAQ evacuatory domain scores and ODS-S show a strong correlation, with an e-PAQ score of ≥33 promising for identifying women with an ODS score of ≥9, indicating ODS. This study will enable us to identify women during pregnancy and post-natally with ODS for whom early recognition and intervention may be beneficial.

MR scan evaluation of pelvic organ prolapse mesh complications and agreement with intra-operative findings.

INTRODUCTION: An increasing number of women are presenting with symptoms after the placement of mesh implants for prolapse which may be attributable to a mesh implant complication. MRI imaging can be used to evaluate abdominally placed mesh but there is no published research evaluating the use of MRI in this group of women. The objective of our study was to report our experience as a tertiary centre in evaluating abdominal mesh with MR imaging and the agreement of MR reports with surgical findings. STUDY DESIGN: A retrospective observational cohort study (Canadian Task Force classification II-2) of all women referred to our tertiary unit who underwent an MR scan for investigation of symptoms of mesh complication following an abdominally placed mesh implant between June 2006 and September 2018 was performed. The reports of MR images were compared with the findings at surgery. RESULTS: MR scan was performed in 87 with suspected mesh complications. MR scan detected mesh failure in 42.1% of women (37/87), infection in 12.6% (11/87), compression in 2.3% (2/87), exposure in 12.6% (11/88), bowel extrusion in 2.3% (2/87) and inflammation in 11.5% (10/87). Agreement between MR scan report and surgical diagnosis was almost perfect for mesh failure, infection and compression, whilst agreement was only moderate for mesh erosion and signs of inflammation (failure κ = 0.97, infection κ = 0.94, compression κ = 1.0, exposure κ = 0.58 and inflammation κ = 0.24). CONCLUSION: These data provide information on the role of MR imaging in the investigation of women presenting with suspected intra-abdominal POP mesh complications including recurrence.

Pessaries (mechanical devices) for managing pelvic organ prolapse in women.

BACKGROUND: Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an ageing population. Women experience a variety of troublesome symptoms as a consequence of prolapse, including a feeling of 'something coming down' into the vagina, pain, urinary symptoms, bowel symptoms and sexual difficulties. Treatment for prolapse includes surgery, pelvic floor muscle training (PFMT) and vaginal pessaries. Vaginal pessaries are passive mechanical devices designed to support the vagina and hold the prolapsed organs back in the anatomically correct position. The most commonly used pessaries are made from polyvinyl-chloride, polythene, silicone or latex. Pessaries are frequently used by clinicians with high numbers of clinicians offering a pessary as first-line treatment for prolapse.  This is an update of a Cochrane Review first published in 2003 and last published in 2013. OBJECTIVES: To assess the effects of pessaries (mechanical devices) for managing pelvic organ prolapse in women; and summarise the principal findings of relevant economic evaluations of this intervention. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 January 2020). We searched the reference lists of relevant articles and contacted the authors of included studies. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in at least one arm of the study. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed abstracts, extracted data, assessed risk of bias and carried out GRADE assessments with arbitration from a third review author if necessary. MAIN RESULTS: We included four studies involving a total of 478 women with various stages of prolapse, all of which took place in high-income countries. In one trial, only six of the 113 recruited women consented to random assignment to an intervention and no data are available for those six women. We could not perform any meta-analysis because each of the trials addressed a different comparison. None of the trials reported data about perceived resolution of prolapse symptoms or about psychological outcome measures. All studies reported data about perceived improvement of prolapse symptoms. Generally, the trials were at high risk of performance bias, due to lack of blinding, and low risk of selection bias. We downgraded the certainty of evidence for imprecision resulting from the low numbers of women participating in the trials. Pessary versus no treatment: at 12 months' follow-up, we are uncertain about the effect of pessaries compared with no treatment on perceived improvement of prolapse symptoms (mean difference (MD) in questionnaire scores -0.03, 95% confidence interval (CI) -0.61 to 0.55; 27 women; 1 study; very low-certainty evidence), and cure or improvement of sexual problems (MD -0.29, 95% CI -1.67 to 1.09; 27 women; 1 study; very low-certainty evidence). In this comparison we did not find any evidence relating to prolapse-specific quality of life or to the number of women experiencing adverse events (abnormal vaginal bleeding or de novo voiding difficulty). Pessary versus pelvic floor muscle training (PFMT): at 12 months' follow-up, we are uncertain if there is a difference between pessaries and PFMT in terms of women's perceived improvement in prolapse symptoms (MD -9.60, 95% CI -22.53 to 3.33; 137 women; low-certainty evidence), prolapse-specific quality of life (MD -3.30, 95% CI -8.70 to 15.30; 1 study; 116 women; low-certainty evidence), or cure or improvement of sexual problems (MD -2.30, 95% -5.20 to 0.60; 1 study; 48 women; low-certainty evidence). Pessaries may result in a large increase in risk of adverse events compared with PFMT (RR 75.25, 95% CI 4.70 to 1205.45; 1 study; 97 women; low-certainty evidence). Adverse events included increased vaginal discharge, and/or increased urinary incontinence and/or erosion or irritation of the vaginal walls. Pessary plus PFMT versus PFMT alone: at 12 months' follow-up, pessary plus PFMT probably leads to more women perceiving improvement in their prolapse symptoms compared with PFMT alone (RR 2.15, 95% CI 1.58 to 2.94; 1 study; 260 women; moderate-certainty evidence). At 12 months' follow-up, pessary plus PFMT probably improves women's prolapse-specific quality of life compared with PFMT alone (median (interquartile range (IQR)) POPIQ score: pessary plus PFMT 0.3 (0 to 22.2); 132 women; PFMT only 8.9 (0 to 64.9); 128 women; P = 0.02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding compared with PFMT alone (RR 2.18, 95% CI 0.69 to 6.91; 1 study; 260 women; low-certainty evidence). The evidence is uncertain if pessary plus PFMT has any effect on the risk of de novo voiding difficulty compared with PFMT alone (RR 1.32, 95% CI 0.54 to 3.19; 1 study; 189 women; low-certainty evidence). AUTHORS' CONCLUSIONS: We are uncertain if pessaries improve pelvic organ prolapse symptoms for women compared with no treatment or PFMT but pessaries in addition to PFMT probably improve women's pelvic organ prolapse symptoms and prolapse-specific quality of life. However, there may be an increased risk of adverse events with pessaries compared to PFMT. Future trials should recruit adequate numbers of women and measure clinically important outcomes such as prolapse specific quality of life and resolution of prolapse symptoms.   The review found two relevant economic evaluations. Of these, one assessed the cost-effectiveness of pessary treatment, expectant management and surgical procedures, and the other compared pessary treatment to PFMT.

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.

Pelvic organ prolapse: self-management of pessaries can be a good option.

The studyHagen S, Kearney R, Goodman K, et al. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial. eClinicalMedicine 2023;66:102326.To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/pelvic-organ-prolapse-self-management-of-pessaries-can-be-a-good-option/.

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.

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.

Vaginal birth and de novo stress incontinence: relative contributions of urethral dysfunction and mobility.

OBJECTIVE: To evaluate the relative contributions of urethral mobility and urethral function to stress incontinence. METHODS: This was a case-control study with group matching. Eighty primiparous women with self-reported new stress incontinence 9-12 months postpartum were compared with 80 primiparous continent controls to identify impairments specific to stress incontinence. Eighty nulliparous continent controls were evaluated as a comparison group to allow us to determine birth-related changes not associated with stress incontinence. Urethral function was measured with urethral profilometry, and vesical neck mobility was assessed with ultrasound and cotton swab test. Urethral sphincter anatomy and mobility were evaluated using magnetic resonance imaging. The associations among urethral closure pressure, vesical neck movement, and incontinence were explored using logistic regression. RESULTS: Urethral closure pressure (+/-standard deviation) in primiparous incontinent women (62.9+/-25.2 cm H(2)0) was lower than in primiparous continent women (83.9+/-21.0, P<.001; effect size d=0.91) who were similar to nulliparous women (90.3+/-25.0, P=.091). Vesical neck movement measured during cough with ultrasonography was the mobility measure most associated with stress incontinence; 15.6+/-6.2 mm in incontinent women compared with 10.9+/-6.2 in primiparous continent women (P<.001, d=0.76) or nulliparas (9.9+/-5.0, P=.322). Logistic regression disclosed the two-variable model (max-rescaled R(2)=0.37, P<.001) was more strongly associated with stress incontinence than either single-variable model, urethral closure pressure (R(2)=0.25, P<.001) or vesical neck movement (R(2)=0.16 P<.001). CONCLUSION: Lower maximal urethral closure pressure is the measure most associated with de novo stress incontinence after first vaginal birth followed by vesical neck mobility. LEVEL OF EVIDENCE: II.

Comparison of levator ani muscle defects and function in women with and without pelvic organ prolapse.

BACKGROUND: To compare levator ani defects and pelvic floor function among women with prolapse and controls. METHODS: Levator ani structure and function were measured in a case-control study with group matching for age, race, and hysterectomy status among 151 women with prolapse (cases) and 135 controls with normal support (controls) determined by pelvic organ prolapse quantification examination. Magnetic resonance imaging was used to determine whether there were "major" (more than half missing), "minor" (less than half of the muscle missing), or no defects in the levator ani muscles. Vaginal closure force at rest and during maximal pelvic muscle contraction was measured with an instrumented vaginal speculum. RESULTS: Cases were more likely to have major levator ani defects than controls (55% compared with 16%), with an adjusted odds ratio of 7.3 (95% confidence interval 3.9-13.6, P<.001) but equally likely to have minor defects (16% compared with 22%). Of women who reported delivery by forceps, 53% had major defects compared with 28% for the nonforceps women, adjusted odds ratio 3.4 (95% confidence interval 1.95-5.78). Women with prolapse generated less vaginal closure force during pelvic muscle contraction than controls (2.0 Newtons compared with 3.2 Newtons P<.001), whereas those with defects generated less force than women without defects (2.0 Newtons compared with 3.1 Newtons, P<.001). The genital hiatus was 50% longer in cases than controls (4.7+/-1.4 cm compared with 3.1+/-1.0 cm, P<.001). CONCLUSION: Women with prolapse more often have defects in the levator ani and generate less vaginal closure force during a maximal contraction than controls. LEVEL OF EVIDENCE: II.