'There's Nothing Wrong With You; You Just Need to Lose Weight'-A Qualitative Exploration of Pelvic Floor Dysfunction Among Women With Multiple Sclerosis and Their Interaction in Seeking Pelvic Healthcare.

INTRODUCTION: Within 10 years of multiple sclerosis (MS) progression, nearly all women will have experienced symptoms associated with bladder, bowel and/or sexual health. Yet despite the impact these symptoms have on physical, psychological and social well-being, it remains an underserved area within the UK healthcare system. STUDY AIM: This research employs a participatory research approach framed within the principles of intersectional feminism to collaboratively investigate the lived experiences of pelvic floor dysfunction (PFD) and healthcare interactions among UK-based women with MS. SETTING AND PARTICIPANTS: Women residing in the United Kingdom with MS were invited to participate in online interviews facilitated by the primary author. ANALYSIS: A thematic framework analysis offering a structured yet adaptable approach to data collection and interpretation. RESULTS: One focus group involving four women with MS and seven individual, one-to-one interviews with women with MS provided insights into the challenges associated with navigating both MS and PFD. Four main themes included: Navigating MS and PFD; Cycles of Control; Mind, Mobility and Bladder Embodiment; Silenced Voices: The Impact of Taboos/Stigma/Dismissal on Preventing Access and Resistance through Collective Community. Six subthemes were also identified. Taken together, these themes cumulatively reflect PFD as an unmet healthcare need. CONCLUSION: Our findings underscore negative healthcare experiences, inadequate information provision and unmet needs related to PFD, emphasising the compounding effects of gender and disability biases. IMPACT: We hope that these insights can lay the groundwork for developing tailored therapeutic interventions and improved PFD healthcare for women with MS. Potential solutions include using existing MS support communities. PUBLIC CONTRIBUTIONS: Women with MS were actively involved in co-producing interview scripts for one-to-one interviews. The primary author shared study findings at an MS group event, engaging in discussions with over 30 individuals, including people with MS and their loved ones. MS advocates played a pivotal role in contextualising the study within the broader lived experience of MS.

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

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

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

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

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

Strategies used for childhood chronic functional constipation: the SUCCESS evidence synthesis.

Background: Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional constipation, potentially with overflow incontinence. Optimal management strategies remain unclear. Objective: To determine the most effective interventions, and combinations and sequences of interventions, for childhood chronic functional constipation, and understand how they can best be implemented. Methods: Key stakeholders, comprising two parents of children with chronic functional constipation, two adults who experienced childhood chronic functional constipation and four health professional/continence experts, contributed throughout the research. We conducted pragmatic mixed-method reviews. For all reviews, included studies focused on any interventions/strategies, delivered in any setting, to improve any outcomes in children (0-18 years) with a clinical diagnosis of chronic functional constipation (excluding studies of diagnosis/assessment) included. Dual reviewers applied inclusion criteria and assessed risk of bias. One reviewer extracted data, checked by a second reviewer. Scoping review: We systematically searched electronic databases (including Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature) (January 2011 to March 2020) and grey literature, including studies (any design) reporting any intervention/strategy. Data were coded, tabulated and mapped. Research quality was not evaluated. Systematic reviews of the evidence of effectiveness: For each different intervention, we included existing systematic reviews judged to be low risk of bias (using the Risk of Bias Assessment Tool for Systematic Reviews), updating any meta-analyses with new randomised controlled trials. Where there was no existing low risk of bias systematic reviews, we included randomised controlled trials and other primary studies. The risk of bias was judged using design-specific tools. Evidence was synthesised narratively, and a process of considered judgement was used to judge certainty in the evidence as high, moderate, low, very low or insufficient evidence. Economic synthesis: Included studies (any design, English-language) detailed intervention-related costs. Studies were categorised as cost-consequence, cost-effectiveness, cost-utility or cost-benefit, and reporting quality evaluated using the consensus health economic criteria checklist. Systematic review of implementation factors: Included studies reported data relating to implementation barriers or facilitators. Using a best-fit framework synthesis approach, factors were synthesised around the consolidated framework for implementation research domains. Results: Stakeholders prioritised outcomes, developed a model which informed evidence synthesis and identified evidence gaps. Scoping review: 651 studies, including 190 randomised controlled trials and 236 primary studies, conservatively reported 48 interventions/intervention combinations. Effectiveness systematic reviews: studies explored service delivery models (n = 15); interventions delivered by families/carers (n = 32), wider children's workforce (n = 21), continence teams (n = 31) and specialist consultant-led teams (n = 42); complementary therapies (n = 15); and psychosocial interventions (n = 4). One intervention (probiotics) had moderate-quality evidence; all others had low to very-low-quality evidence. Thirty-one studies reported evidence relating to cost or resource use; data were insufficient to support generalisable conclusions. One hundred and six studies described implementation barriers and facilitators. Conclusions: Management of childhood chronic functional constipation is complex. The available evidence remains limited, with small, poorly conducted and reported studies. Many evidence gaps were identified. Treatment recommendations within current clinical guidelines remain largely unchanged, but there is a need for research to move away from considering effectiveness of single interventions. Clinical care and future studies must consider the individual characteristics of children. Study registration: This study is registered as PROSPERO CRD42019159008. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 128470) and is published in full in Health Technology Assessment; Vol. 28, No. 5. See the NIHR Funding and Awards website for further award information.

Between 5% and 30% of children experience constipation at some stage. In one-third of these children, this progresses to chronic functional constipation. Chronic functional constipation affects more children with additional needs. We aimed to find and bring together published information about treatments for chronic functional constipation, to help establish best treatments and treatment combinations. We did not cover assessment or diagnosis of chronic functional constipation. This project was guided by a 'stakeholder group', including parents of children with constipation, people who experienced constipation as children, and healthcare professionals/continence experts. We carried out a 'scoping review' and a series of 'systematic reviews'. Our 'scoping review' provides an overall picture of research about treatments, with 651 studies describing 48 treatments. This helps identify important evidence gaps. 'Systematic reviews' are robust methods of bringing together and interpreting research evidence. Our stakeholder group decided to structure our systematic reviews to reflect who delivered the interventions. We brought together evidence about how well treatments worked when delivered by families/carers (32 studies), the wider children's workforce (e.g. general practitioner, health visitor) (21 studies), continence teams (31 studies) or specialist consultant-led teams (42 studies). We also considered complementary therapies (15 studies) and behavioural strategies (4 studies). Care is affected by what is done and how it is done. We brought together evidence about different models of delivering care (15 studies), barriers and facilitators to implementation of treatments (106 studies) and costs (31 studies). Quality of evidence was mainly low to very low. Despite numerous studies, there was often insufficient information to support generalisable conclusions. Our findings generally agreed with current clinical guidelines. Management of childhood chronic functional constipation should be child-centred, multifaceted and adapted according to the individual child, their needs, the situation in which they live and the health-care setting in which they are looked after. Research is needed to address our identified evidence gaps.

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.

Conservative interventions for treating urinary incontinence in women: an Overview of Cochrane systematic reviews.

BACKGROUND: Urinary incontinence (UI) is the involuntary loss of urine and can be caused by several different conditions. The common types of UI are stress (SUI), urgency (UUI) and mixed (MUI). A wide range of interventions can be delivered to reduce the symptoms of UI in women. Conservative interventions are generally recommended as the first line of treatment. OBJECTIVES: To summarise Cochrane Reviews that assessed the effects of conservative interventions for treating UI in women. METHODS: We searched the Cochrane Library to January 2021 (CDSR; 2021, Issue 1) and included any Cochrane Review that included studies with women aged 18 years or older with a clinical diagnosis of SUI, UUI or MUI, and investigating a conservative intervention aimed at improving or curing UI. We included reviews that compared a conservative intervention with 'control' (which included placebo, no treatment or usual care), another conservative intervention or another active, but non-conservative, intervention. A stakeholder group informed the selection and synthesis of evidence. Two overview authors independently applied the inclusion criteria, extracted data and judged review quality, resolving disagreements through discussion. Primary outcomes of interest were patient-reported cure or improvement and condition-specific quality of life. We judged the risk of bias in included reviews using the ROBIS tool. We judged the certainty of evidence within the reviews based on the GRADE approach. Evidence relating to SUI, UUI or all types of UI combined (AUI) were synthesised separately. The AUI group included evidence relating to participants with MUI, as well as from studies that combined women with different diagnoses (i.e. SUI, UUI and MUI) and studies in which the type of UI was unclear. MAIN RESULTS: We included 29 relevant Cochrane Reviews. Seven focused on physical therapies; five on education, behavioural and lifestyle advice; one on mechanical devices; one on acupuncture and one on yoga. Fourteen focused on non-conservative interventions but had a comparison with a conservative intervention. No reviews synthesised evidence relating to psychological therapies. There were 112 unique trials (including 8975 women) that had primary outcome data included in at least one analysis. Stress urinary incontinence (14 reviews) Conservative intervention versus control: there was moderate or high certainty evidence that pelvic floor muscle training (PFMT), PFMT plus biofeedback and cones were more beneficial than control for curing or improving UI. PFMT and intravaginal devices improved quality of life compared to control. One conservative intervention versus another conservative intervention: for cure and improvement of UI, there was moderate or high certainty evidence that: continence pessary plus PFMT was more beneficial than continence pessary alone; PFMT plus educational intervention was more beneficial than cones; more-intensive PFMT was more beneficial than less-intensive PFMT; and PFMT plus an adherence strategy was more beneficial than PFMT alone. There was no moderate or high certainty evidence for quality of life. Urgency urinary incontinence (five reviews) Conservative intervention versus control: there was moderate to high-certainty evidence demonstrating that PFMT plus feedback, PFMT plus biofeedback, electrical stimulation and bladder training were more beneficial than control for curing or improving UI. Women using electrical stimulation plus PFMT had higher quality of life than women in the control group. One conservative intervention versus another conservative intervention: for cure or improvement, there was moderate certainty evidence that electrical stimulation was more effective than laseropuncture. There was high or moderate certainty evidence that PFMT resulted in higher quality of life than electrical stimulation and electrical stimulation plus PFMT resulted in better cure or improvement and higher quality of life than PFMT alone. All types of urinary incontinence (13 reviews) Conservative intervention versus control: there was moderate to high certainty evidence of better cure or improvement with PFMT, electrical stimulation, weight loss and cones compared to control. There was moderate certainty evidence of improved quality of life with PFMT compared to control. One conservative intervention versus another conservative intervention: there was moderate or high certainty evidence of better cure or improvement for PFMT with bladder training than bladder training alone. Likewise, PFMT with more individual health professional supervision was more effective than less contact/supervision and more-intensive PFMT was more beneficial than less-intensive PFMT. There was moderate certainty evidence that PFMT plus bladder training resulted in higher quality of life than bladder training alone. AUTHORS' CONCLUSIONS: There is high certainty that PFMT is more beneficial than control for all types of UI for outcomes of cure or improvement and quality of life. We are moderately certain that, if PFMT is more intense, more frequent, with individual supervision, with/without combined with behavioural interventions with/without an adherence strategy, effectiveness is improved. We are highly certain that, for cure or improvement, cones are more beneficial than control (but not PFMT) for women with SUI, electrical stimulation is beneficial for women with UUI, and weight loss results in more cure and improvement than control for women with AUI. Most evidence within the included Cochrane Reviews is of low certainty. It is important that future new and updated Cochrane Reviews develop questions that are more clinically useful, avoid multiple overlapping reviews and consult women with UI to further identify outcomes of importance.

Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis.

BACKGROUND: Neurogenic lower urinary tract dysfunction is an abnormality in the presence of underlying neurologic disease. A recent systematic review and meta-analysis demonstrated that storage phase symptoms are the predominant symptoms among people with multiple sclerosis (PwMS). Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive treatment for bladder storage symptoms; however, the potential efficacy of stimulation among PwMS is based on a small number of studies with the absence of high-quality evidence. The aim of this study was to evaluate the feasibility, acceptability, and safety of TTNS in PwMS using an affordable transcutaneous electrical nerve stimulation (TENS) unit. METHODS: A total of 23 participants with MS enrolled in the study. The primary outcomes included recruitment/retention rate, completion of the outcomes and the intervention, adherence to the protocol, adverse events, and acceptability of the intervention. The primary outcomes were assessed using diaries and a satisfaction questionnaire. The secondary outcomes included changes in urinary symptoms and quality of life assessed using a set of validated outcome measures including a 3-day bladder diary, PPIUS, ICIQ-OAB, and KHQ at baseline and post-intervention. RESULTS: Twenty participants completed the study. Three participants (13.04%) withdrew. All 20 participants completed the 6-week intervention and all the outcome measures (100%), with no reported adverse events. Participants were satisfied and found the unit acceptable. Three-day bladder diary showed changes in urinary frequency from a daily median of 10 times to 8 times and daily median urgency changed from 6 times at baseline to 2 times post-intervention. PPIUS showed changes in daily median sever urgency from 3 points (IQR=4) to 1 point (IQR=1) post-intervention. ICIQ-OAB total scores changed from 8 points (IQR=2.25) to 4 points (IQR=2.5) post-intervention. Median and mean scores of KHQ showed a clinical meaningful change of QoL in part-two and part-three of the questionnaire. CONCLUSIONS: TTNS is feasible, safe, and acceptable for PwMS. Changes of urinary symptoms scores and QoL post-intervention suggested improvements. Future implications need to consider the treatment protocol including frequency of treatment sessions, duration of treatment, and the electrical stimulation parameters as well as the outcome measures followed in the current study for the implementation of the future pilot RCT. TRIAL REGISTRATION: ClinicalTrials.gov NCT04528784 . Registered on 27 August 2020. https://register. CLINICALTRIALS: gov/prs/app/action/LoginUser?ts=1&cx=-jg9qo4 .

Stimulation of the tibial nerve-a randomised trial for urinary problems associated with Parkinson's-the STARTUP trial.

BACKGROUND: non-motor symptoms such as bladder dysfunction are common (80%) in people with Parkinson's increasing the risk for falls with a negative impact on health-related costs and quality of life.We undertook STARTUP to evaluate the clinical and cost-effectiveness of using an adhesive electrode to stimulate the transcutaneous tibial nerve stimulation (TTNS) to treat bladder dysfunction in people with Parkinson's disease (PD).Study design, materials and methods: STARTUP was a parallel two-arm, multi-centre, pragmatic, double-blind, randomised controlled trial. Each participant attended one clinic visit to complete consent, be randomised using a computer-generated system and to be shown how to use the device.The trial had two co-primary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score (IPSS). These were completed at baseline, 6 and 12 weeks. A bladder frequency chart and resource questionnaire were also completed. RESULTS: two hundred forty two participants were randomised. About 59% of participants were male, the mean age was 69 years and mean time since diagnosis was 6 years. Questionnaire return rate was between 79 and 90%.There was a statistically significantly lower score in the active group at 6 weeks in the IPSS questionnaire (mean difference (Standard deviation, SD) 12.5 (6.5) vs 10.9 (5.5), effect size -1.49, 95% CI -2.72, -0.25). There was no statistically significant change in any other outcome. CONCLUSION: TTNS was demonstrated to be safe with a high level of compliance. There was a significant change in one of the co-primary outcome measures at the end of the treatment period (i.e. 6 weeks), which could indicate a benefit. Further fully powered RCTs are required to determine effective treatments.

A Qualitative Study of Health Care Professionals' Views on Bowel Care in Multiple Sclerosis: Whose Job Is It Anyway?

Background: Bowel dysfunction, including constipation and fecal incontinence, is prevalent in individuals with multiple sclerosis (MS), adversely affecting quality of life and increasing caregiver burden. How health care professionals (HCPs) identify, assess, and manage people with MS with bowel dysfunction is understudied. This study explored how HCPs think about, assess, and manage bowel dysfunction in individuals with MS. Methods: Semistructured interviews were conducted with 18 HCPs from different professional disciplines and clinical specialties recruited from UK National Health Service primary, secondary, and tertiary care services using purposive and chain referral sampling through professional networks. One participant worked for a bladder and bowel charity. Data were analyzed using thematic analysis. Results: Views differed regarding responsibilities for providing bowel care. Participants thought individuals with MS should notify HCPs of bowel symptoms and take responsibility for self-management where possible, with family caregivers required to help with bowel care. Although people with MS were often referred to bladder and bowel specialists when a crisis point was reached, earlier referral was called for by these HCPs. There were variations in assessment processes, treatment options offered, and service provision. Participants thought HCPs needed more education on bowel dysfunction, bowel care should take a high priority, and evidence-based clinical guidelines and referral pathways would improve service delivery. Conclusions: The HCPs caring for individuals with MS see many with bowel dysfunction, and there is variation in care and service provision; HCPs require more education, evidence-based clinical guidelines, and referral pathways to improve case finding, assessment, and management of these symptoms for individuals with MS.

Management strategies for neurogenic lower urinary tract dysfunction: a qualitative study of the experiences of people with multiple sclerosis and healthcare professionals.

PURPOSE: Urinary symptoms are highly prevalent among people with MS. This study aimed to explore the experiences of people with MS and HCPs in managing urinary symptoms and explore their views on using TTNS to treat urinary symptoms. MATERIALS AND METHODS: Audio-recorded semi-structured, interviews were employed with people with MS and HCPs. All transcribed interviews were exported to NVivo software (Version 12) and analyzed using a reflexive approach to thematic analysis. RESULTS: Four main themes were identified; The wide-ranging negative impacts of urinary symptoms ("It's limited everything else"), Gaps in urinary services ("Is there somebody like that, sort of specialized in that area?"), Management strategies ("I don't go too far from the toilet in case I need to use one"), and optimism about TTNS ("Are you giving Me Hope?"). CONCLUSION: Urinary symptoms are common and very troublesome for people with MS. Despite their prevalence, many people with MS continue to suffer in silence. People with MS require skilled multidisciplinary services guided by clinical care pathways to improve service provision and to address urinary symptoms. HCP's and people with MS are open to the use of TTNS for urinary symptoms and have clear preferences for location and duration of intervention delivery.Implications for rehabilitationUrinary symptoms are very common and troublesome for people with multiple sclerosis, yet many continue to suffer in silence.People with multiple sclerosis lack knowledge about treatment options for urinary symptoms.There is an on-going need for healthcare provider education on guidelines for screening and managing urinary symptoms in people with MS and the role of specialist urinary service providers.HCP's and people with MS are open to the use of TTNS for urinary symptoms.

Tibial nerve stimulation compared with sham to reduce incontinence in care home residents: ELECTRIC RCT.

BACKGROUND: Urinary incontinence is prevalent in nursing and residential care homes, and has a profound impact on residents' dignity and quality of life. Treatment options are limited in these care contexts and care homes predominantly use absorbent pads to contain incontinence, rather than actively treat it. Transcutaneous posterior tibial nerve stimulation is a non-invasive, safe, low-cost intervention that is effective in reducing urinary incontinence in adults. OBJECTIVE: To determine the clinical effectiveness of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and to determine the associated costs of the treatment. DESIGN: A multicentre, pragmatic, participant and outcome assessor-blind, randomised placebo-controlled trial. SETTING: A total of 37 UK residential and nursing care homes. PARTICIPANTS: Care home residents with at least weekly urinary incontinence that is contained using absorbent pads and who are able to use a toilet/toilet aid with or without assistance. INTERVENTIONS: Residents were randomised (1 : 1) to receive 12 30-minute sessions of transcutaneous posterior tibial nerve stimulation or sham stimulation over a 6-week period. MAIN OUTCOME MEASURES: Primary outcome - change in volume of urine leaked over a 24-hour period at 6 weeks. Secondary outcomes - number of pads used, Perception of Bladder Condition, toileting skills, quality of life and resource use. RESULTS: A total of 408 residents were randomised (transcutaneous posterior tibial nerve stimulation, n = 197; sham stimulation, n = 209); two exclusions occurred post randomisation. Primary outcome data were available for 345 (85%) residents (transcutaneous posterior tibial nerve stimulation, n = 167; sham stimulation, n = 178). Adherence to the intervention protocol was as follows: 78% of the transcutaneous posterior tibial nerve stimulation group and 71% of the sham group received the correct stimulation. Primary intention-to-treat adjusted analysis indicated a mean change of -5 ml (standard deviation 362 ml) urine leakage from baseline in the transcutaneous posterior tibial nerve stimulation group and -66 ml (standard deviation 394 ml) urine leakage in the sham group, which was a statistically significant, but not clinically important, between-group difference of 68-ml urine leakage (95% confidence interval 0 to 136 ml; p = 0.05) in favour of the sham group. Sensitivity analysis supported the primary analysis. No meaningful differences were detected in any of the secondary outcomes. No serious adverse events related to transcutaneous posterior tibial nerve stimulation were reported. Economic evaluation assessed the resources used. The training and support costs for the staff to deliver the intervention were estimated at £121.03 per staff member. Estimated costs for delivery of transcutaneous posterior tibial nerve stimulation during the trial were £81.20 per participant. No significant difference was found between participants' scores over time, or between transcutaneous posterior tibial nerve stimulation and sham groups at any time point, for resident or proxy quality-of-life measures. CONCLUSIONS: The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial showed, in the care home context (with a high proportion of residents with poor cognitive capacity and limited independent mobility), that transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence. No economic case for transcutaneous posterior tibial nerve stimulation was made by the cost-consequences analysis; however, the positive reception of learning about urinary incontinence for care home staff supports a case for routine education in this care context. LIMITATIONS: Completing 24-hour pad collections was challenging for care home staff, resulting in some missing primary outcome data. FUTURE WORK: Research should investigate transcutaneous posterior tibial nerve stimulation in residents with urgency urinary incontinence to determine whether or not targeted stimulation is effective. Research should evaluate the effects of continence training for staff on continence care in care homes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN98415244 and ClinicalTrials.gov NCT03248362. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 41. See the NIHR Journals Library website for further project information.

Bladder leakage (urinary incontinence) is common among people living in care homes. Most people wear absorbent pads to contain urine leakage, but this does not treat the cause of incontinence. Transcutaneous posterior tibial nerve stimulation is a treatment for the type of incontinence associated with a sudden need to use the toilet (urgency incontinence). Two sticky patches applied to the ankle are connected to a small electrical stimulator. The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial looked at whether or not transcutaneous posterior tibial nerve stimulation can help reduce incontinence for people in care homes. A total of 406 residents from 37 care homes were given transcutaneous posterior tibial nerve stimulation treatment or a dummy treatment for 30 minutes, twice per week for 6 weeks. The amount of urine leaked by each resident was measured over 24 hours by collecting all pads used in a sealable plastic bag and weighing the bag. This happened after the final transcutaneous posterior tibial nerve stimulation or dummy treatment, and again after 3 and 5 months. Residents, family members and care home staff were asked if they thought that the transcutaneous posterior tibial nerve stimulation had any effect and for their views of the treatment. We found no important difference in leakage between residents who had the transcutaneous posterior tibial nerve stimulation and those who had the dummy treatment. There were also no differences in daily pad use, feelings about bladder condition or quality of life. It cost around £120 to train staff to deliver transcutaneous posterior tibial nerve stimulation and around £80 per person to have transcutaneous posterior tibial nerve stimulation treatment. Transcutaneous posterior tibial nerve stimulation had no serious side-effects. Care home residents, even those with severe dementia, found the application of transcutaneous posterior tibial nerve stimulation acceptable. Staff found learning about incontinence helpful, but continence care routines did not change. In summary, the ELECTRIC trial found that for very dependent older people in care homes, transcutaneous posterior tibial nerve stimulation did not reduce urinary incontinence. The findings do not support transcutaneous posterior tibial nerve stimulation use to reduce urinary incontinence in care home environments.

An International Continence Society (ICS) report on the terminology for pelvic floor muscle assessment.

INTRODUCTION: The terminology for female and male pelvic floor muscle (PFM) assessment has expanded considerably since the first PFM function and dysfunction standardization of terminology document in 2005. New terms have entered assessment reports, and new investigations to measure PFM function and dysfunction have been developed. An update of this terminology was required to comprehensively document the terms and their definitions, and to describe the assessment method and interpretation of the finding, to standardize assessment procedures and aid diagnostic decision making. METHODS: This report combines the input of members of the Standardisation Committee of the International Continence Society (ICS) Working Group 16, with contributions from recognized experts in the field and external referees. A logical, sequential, clinically directed assessment framework was created against which the assessment process was mapped. Within categories and subclassifications, each term was assigned a numeric coding. A transparent process of 12 rounds of full working group and external review was undertaken to exhaustively examine each definition, plus additional extensive internal development, with decision making by collective opinion (consensus). RESULTS: A Terminology Report for the symptoms, signs, investigations, and diagnoses associated with PFM function and dysfunction, encompassing 185 separate definitions/descriptors, has been developed. It is clinically based with the most common assessment processes defined. Clarity and user-friendliness have been key aims to make it interpretable by clinicians and researchers of different disciplines. CONCLUSION: A consensus-based Terminology Report for assessment of PFM function and dysfunction has been produced to aid clinical practice and be a stimulus for research.

Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT.

BACKGROUND: Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. DESIGN: A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. SETTING: This trial was set in UK community and outpatient care settings. PARTICIPANTS: Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. INTERVENTIONS: Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions. MAIN OUTCOME MEASURES: The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0-21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. RESULTS: A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference -0.09, 95% confidence interval -0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. LIMITATIONS: Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. CONCLUSIONS: There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. FUTURE WORK: Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. TRIAL REGISTRATION: Current Controlled Trial ISRCTN57746448. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.

Urinary incontinence (accidental leakage of urine) is a common and embarrassing problem for women. Pregnancy and childbirth may contribute by leading to less muscle support and bladder control. Pelvic floor exercises and 'biofeedback' equipment (a device that lets women see the muscles working as they exercise) are often used in treatment. There is good evidence that exercises (for the pelvic floor) can help, but less evidence about whether or not adding biofeedback provides better results. This trial compared pelvic floor exercises alone with pelvic floor exercises plus biofeedback. Six hundred women with urinary incontinence participated. Three hundred women were randomly assigned to the exercise group and 300 women were randomised to the exercise plus biofeedback group. Each woman had an equal chance of being in either group. Women were offered six appointments with a therapist over 16 weeks to receive their allocated treatment. After 2 years, there was no difference between the groups in the severity of women's urinary incontinence. Women in both groups varied in how much exercise they managed to do. Some managed to exercise consistently over the 2 years and others less so. There were many factors (other than the treatment received) that affected a woman's ability to exercise. Notably, women viewed the therapists' input very positively. The therapists reported some problems fitting biofeedback into the appointments, but, overall, they delivered both treatments as intended. Women carried out exercises at home and many in the biofeedback pelvic floor muscle training group also used biofeedback at home; however, for both groups, time issues, forgetting and other health problems affected their adherence. There were no serious complications related to either treatment. Overall, exercise plus biofeedback was not significantly more expensive than exercise alone and the quality of life associated with exercise plus biofeedback was not better than the quality of life for exercise alone. In summary, exercises plus biofeedback was no better than exercise alone. The findings do not support using biofeedback routinely as part of pelvic floor exercise treatment for women with urinary incontinence.

Interventions to support the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic: a mixed methods systematic review.

BACKGROUND: Evidence from disease epidemics shows that healthcare workers are at risk of developing short- and long-term mental health problems. The World Health Organization (WHO) has warned about the potential negative impact of the COVID-19 crisis on the mental well-being of health and social care professionals. Symptoms of mental health problems commonly include depression, anxiety, stress, and additional cognitive and social problems; these can impact on function in the workplace. The mental health and resilience (ability to cope with the negative effects of stress) of frontline health and social care professionals ('frontline workers' in this review) could be supported during disease epidemics by workplace interventions, interventions to support basic daily needs, psychological support interventions, pharmacological interventions, or a combination of any or all of these. OBJECTIVES: Objective 1: to assess the effects of interventions aimed at supporting the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic. Objective 2: to identify barriers and facilitators that may impact on the implementation of interventions aimed at supporting the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic. SEARCH METHODS: On 28 May 2020 we searched the Cochrane Database of Systematic Reviews, CENTRAL, MEDLINE, Embase, Web of Science, PsycINFO, CINAHL, Global Index Medicus databases and WHO Institutional Repository for Information Sharing. We also searched ongoing trials registers and Google Scholar. We ran all searches from the year 2002 onwards, with no language restrictions. SELECTION CRITERIA: We included studies in which participants were health and social care professionals working at the front line during infectious disease outbreaks, categorised as epidemics or pandemics by WHO, from 2002 onwards. For objective 1 we included quantitative evidence from randomised trials, non-randomised trials, controlled before-after studies and interrupted time series studies, which investigated the effect of any intervention to support mental health or resilience, compared to no intervention, standard care, placebo or attention control intervention, or other active interventions. For objective 2 we included qualitative evidence from studies that described barriers and facilitators to the implementation of interventions. Outcomes critical to this review were general mental health and resilience. Additional outcomes included psychological symptoms of anxiety, depression or stress; burnout; other mental health disorders; workplace staffing; and adverse events arising from interventions. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently applied selection criteria to abstracts and full papers, with disagreements resolved through discussion. One review author systematically extracted data, cross-checked by a second review author. For objective 1, we assessed risk of bias of studies of effectiveness using the Cochrane 'Risk of bias' tool. For objective 2, we assessed methodological limitations using either the CASP (Critical Appraisal Skills Programme) qualitative study tool, for qualitative studies, or WEIRD (Ways of Evaluating Important and Relevant Data) tool, for descriptive studies. We planned meta-analyses of pairwise comparisons for outcomes if direct evidence were available. Two review authors extracted evidence relating to barriers and facilitators to implementation, organised these around the domains of the Consolidated Framework of Implementation Research, and used the GRADE-CERQual approach to assess confidence in each finding. We planned to produce an overarching synthesis, bringing quantitative and qualitative findings together. MAIN RESULTS: We included 16 studies that reported implementation of an intervention aimed at supporting the resilience or mental health of frontline workers during disease outbreaks (severe acute respiratory syndrome (SARS): 2; Ebola: 9; Middle East respiratory syndrome (MERS): 1; COVID-19: 4). Interventions studied included workplace interventions, such as training, structure and communication (6 studies); psychological support interventions, such as counselling and psychology services (8 studies); and multifaceted interventions (2 studies). Objective 1: a mixed-methods study that incorporated a cluster-randomised trial, investigating the effect of a work-based intervention, provided very low-certainty evidence about the effect of training frontline healthcare workers to deliver psychological first aid on a measure of burnout. Objective 2: we included all 16 studies in our qualitative evidence synthesis; we classified seven as qualitative and nine as descriptive studies. We identified 17 key findings from multiple barriers and facilitators reported in studies. We did not have high confidence in any of the findings; we had moderate confidence in six findings and low to very low confidence in 11 findings. We are moderately confident that the following two factors were barriers to intervention implementation: frontline workers, or the organisations in which they worked, not being fully aware of what they needed to support their mental well-being; and a lack of equipment, staff time or skills needed for an intervention. We are moderately confident that the following three factors were facilitators of intervention implementation: interventions that could be adapted for local needs; having effective communication, both formally and socially; and having positive, safe and supportive learning environments for frontline workers. We are moderately confident that the knowledge or beliefs, or both, that people have about an intervention can act as either barriers or facilitators to implementation of the intervention. AUTHORS' CONCLUSIONS: There is a lack of both quantitative and qualitative evidence from studies carried out during or after disease epidemics and pandemics that can inform the selection of interventions that are beneficial to the resilience and mental health of frontline workers. Alternative sources of evidence (e.g. from other healthcare crises, and general evidence about interventions that support mental well-being) could therefore be used to inform decision making. When selecting interventions aimed at supporting frontline workers' mental health, organisational, social, personal, and psychological factors may all be important. Research to determine the effectiveness of interventions is a high priority. The COVID-19 pandemic provides unique opportunities for robust evaluation of interventions. Future studies must be developed with appropriately rigorous planning, including development, peer review and transparent reporting of research protocols, following guidance and standards for best practice, and with appropriate length of follow-up. Factors that may act as barriers and facilitators to implementation of interventions should be considered during the planning of future research and when selecting interventions to deliver within local settings.

Implementing pelvic floor muscle training for women with pelvic organ prolapse: a realist evaluation of different delivery models.

BACKGROUND: Pelvic Floor Muscle Training (PFMT) has been shown to be effective for pelvic organ prolapse in women, but its implementation in routine practice is challenging due to lack of adequate specialist staff. It is important to know if PFMT can be delivered by different staff skill mixes, what barriers and facilitators operate in different contexts, what strategies enable successful implementation and what are the underlying mechanisms of their action. PROPEL intervention was designed to maximise the delivery of effective PFMT in the UK NHS using different staff skill mixes. We conducted a realist evaluation (RE) of this implementation to understand what works, for whom, in what circumstances and why. METHODS: Informed by the Realist and RE-AIM frameworks, the study used a longitudinal, qualitative, multiple case study design. The study took place in five, purposively selected, diverse NHS sites across the UK and proceeded in three phases to identify, test and refine a theory of change. Data collection took place at 4 time points over an 18 month implementation period using focus groups and semi-structured interviews with a range of stakeholders including service leads/managers, senior practitioners, newly trained staff and women receiving care in the new service models. Data were analysed using thematic framework approach adapted to identify Context, Mechanism and Outcome (CMO) configurations of the RE. RESULTS: A heightened awareness of the service need among staff and management was a mechanism for change, particularly in areas where there was a shortage of skilled staff. In contrast, the most established specialist physiotherapist-delivered PFMT service activated feelings of role protection and compromised quality, which restricted the reach of PFMT through alternative models. Staff with some level of prior knowledge in women's health and adequate organisational support were more comfortable and confident in new role. Implementation was seamless when PFMT delivery was incorporated in newly trained staff's role and core work. CONCLUSION: Roll-out of PFMT delivery through different staff skill mixes is possible when it is undertaken by clinicians with an interest in women's health, and carefully implemented ensuring adequate levels of training and ongoing support from specialists, multi-disciplinary teams and management.

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.

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.

Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial.

OBJECTIVE: To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women. DESIGN: Parallel group randomised controlled trial. SETTING: 23 community and secondary care centres providing continence care in Scotland and England. PARTICIPANTS: 600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone. INTERVENTIONS: Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments. MAIN OUTCOME MEASURES: The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years. RESULTS: Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions. CONCLUSIONS: At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated. TRIAL REGISTRATION: ISRCTN57756448.