Objectives This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To compare the different treatments (conservative, pharmacological, and surgical) in terms of cure or cure and improvement of urinary incontinence, and adverse events, in women aged 60 and over through a network meta‐analysis, and ranking the numerous interventions within one treatment network.

Objective To compare long-term clinical and cost-effectiveness of pessary self-management (SM) with clinic-based care (CBC) for pelvic floor-specific quality of life (QoL).Design Four-year questionnaire follow-up of trial participants.Setting UK pessary clinics.Sample Responders at 4 years aged >= 18 years at recruitment, using a pessary (except Shelf, Gellhorn or Cube) which had been retained >= 2 weeks. Exclusions: limited manual dexterity; cognitive deficit; pregnancy; requiring non-English SM teaching.Methods SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received routine appointments. Allocation was by remote web-based application, minimised on age, user type (new/existing) and centre with no blinding. Participants were invited to opt into a 4-year follow-up. The primary analysis was intention to treat.Outcome Measures The primary outcomes were pelvic floor-specific QoL (PFIQ-7) and incremental net monetary benefit (INB) 4 years post-randomisation. Secondary outcomes included complications and prolapse symptoms.Results Of 340 women randomised, 186 (55%) responded at 4 years (86/169 [51%] SM, 100/171 [58%] CBC). There was no statistically significant group difference in PFIQ-7 at 4 years (mean SM 32.9 vs. CBC 31.4, adjusted mean difference [AMD] SM-CBC 4.86, 95% CI -6.41 to 16.12). There was a statistically non-significant lower percentage of pessary complications for SM (SM 17.7% vs. CBC 22.0%, AMD 3.01 CI -0.58 to 6.61). At 4-years, SM was cost-effective (INB 2240) pound. There was one potentially related serious adverse event (SM group).Conclusions Pessary self-management is an effective and cost-effective long-term option for women with prolapse.Trial Registration ISRCTN number: 62510577 (https://doi.org/10.1186/ISRCTN62510577)

Objectives To explore the feasibility and acceptability of pain management (transcutaneous electrical nerve stimulation (TENS)) and patient education (PE) to increase physical activity in people with peripheral arterial disease and intermittent claudication (IC).Design Feasibility randomised controlled trial with embedded process evaluation.Setting One secondary care UK vascular centre.Participants 56 community-dwelling adults with a history of stable IC and ankle-brachial pressure index ≤0.9 were recruited via claudication clinics.Interventions Participants randomised to 6 weeks of: TENS+PE, TENS, Placebo TENS+PE or Placebo TENS. PE was a 3-hour workshop plus three follow-up phone calls. The TENS machine was worn during walking (TENS: 120 Hz, 200 μs, intensity ‘strong but comfortable’; Placebo TENS: intensity below sensation threshold).Outcomes Primary feasibility outcomes included rates of recruitment, retention and adherence. Acceptability of the intervention and trial procedures was explored with semistructured interviews. Measures of walking capacity, walking behaviour, quality of life, disease perception and pain were recorded at baseline, end of intervention (6 weeks) and follow-up (3 months).Results 56 participants were randomised from 95 who completed baseline screening. Of the 39 excluded, 97% (38/39) had >20% variability in absolute claudication distance. All participants received their allocated intervention. Outcome completion was 91% at 6 weeks and 80% at 3 months. Attendance at group education was 96% with 63% taking follow-up phone calls. Compliance with TENS was 70% according to participant-completed logs. Interviewed participants (n=9) were generally positive about the acceptability of the interventions and trial procedures; however, experience of TENS use was mixed. Some participants were dissatisfied with the size of the device and electrode wires.Conclusions The PrEPAID (Pain management and Patient Education for Physical Activity in Intermittent claudication) trial was feasible to run; however, 40% of potential participants were excluded at screening due to issues of research fidelity rather than participant suitability or willingness to participate. A future definitive trial should consider a revised primary outcome measure and smaller wireless TENS machines.Trial registration number ClinicalTrials.gov, NCT03204825. Registered on 2 July 2017.Trial funding Chief Scientist Office, Scottish Government. Translational grant award (TCS/16/55).

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 selfmanagement 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. vParticipants: 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 pound per quality -adjusted life -year gained, with an estimated incremental net benefit of 564.32 pound 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 selfmanaging 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

ObjectiveTo investigate pelvic floor dysfunction (PFD; urinary incontinence (UI), faecal incontinence (FI) and prolapse) >= 20 years after childbirth and their association with delivery mode history and demographic characteristics.DesignCohort study with long-term follow-up.SettingMaternity units in Aberdeen and Birmingham (UK) and Dunedin (NZ).PopulationWomen giving birth in 1993/1994.MethodsPostal questionnaires at 20 (New Zealand) or 26 (United Kingdom) years after index birth (n = 6195). Regression analyses investigated associations between risk factors and UI, FI and prolapse symptoms.Main Outcome MeasuresPrevalence of self-reported UI, FI, 'something coming down' from or in the vagina (SCD), and the Pelvic Organ Prolapse-Symptom Score, and relationships with delivery method.ResultsThirty-seven per cent (n = 2270) responded at 20/26 years, of whom 61% reported UI (59% of whom reported more severe UI), 22% FI and 17% prolapse symptoms. Having only caesarean section (CS) was associated with a significantly lower risk of UI (OR 0.63, 95% CI 0.46-0.85), FI (OR 0.63, 95% CI 0.42-0.96) and SCD (OR 0.44, 95% CI 0.27-0.74) compared to only spontaneous vaginal deliveries (SVDs). Having any forceps delivery was associated with reporting FI compared to only SVDs (OR 1.29, 95% CI 1.00-1.66), but there was no association for UI (OR 0.95, 95% CI 0.76-1.19) or SCD (OR 1.05, 95% CI 0.80-1.38). Higher current BMI was associated with all PFD outcomes.ConclusionsPrevalence of PFD continues to increase up to 26 years following index birth, and differences were observed according to delivery mode history. Exclusive CS was associated with less risk of UI, FI and any prolapse symptoms.

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.

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 selfmanagement (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 lea flet, 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 signi ficant 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 pound vs 728) pound. The incremental net bene fit estimated at a willingness to pay of 20 pound 000 per QALY gained was 564 pound, with an 80.8% probability of cost-effectiveness. The modeling results were consistent with the trial analysis: the incremental net bene fit was estimated as 4221 pound, 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.

This paper describes the development process of the ‘SKIP IT’ text messaging intervention to promote smoking cessation during pregnancy. Smoking during pregnancy is a major risk to mother and infant health. Pregnant women who smoke are more likely to experience complications during pregnancy, and babies born to women who smoke are likely to experience ongoing health needs. Previous interventions for reducing smoking in pregnant women have shown limited effectiveness. The objective was to develop an effective intervention to promote smoking cessation during pregnancy by examining the complex set of needs for facilitating positive behaviour change. This included engaging with clinicians and the target group of pregnant smokers to ensure the intervention is feasible and acceptable. Due to the linear nature of this development methods and results are presented together. Step 1: Literature review methods A series of literature reviews were carried to explore existing psychological theory relating to smoking cessation during pregnancy. The result was six ‘elements’ that, if achieved, are likely to increase the likelihood of a successful quit attempt: Step 2: Qualitative interviews Qualitative interviews were conducted with key stakeholder groups. The setting for this qualitative work was one large maternity unit in Scotland. Evidence supporting each of the ‘elements’ developed from the literature review was present. Step 3: Intervention development Evidence from the literature reviews and qualitative interviews was collated and a prototype intervention was developed based on storytelling and images. The final intervention consisted of frequent text messages sent to participants from a fictional character, ‘Megan’, who was designed as a coping model. Images corresponding to the current size of the fetus were sent weekly. Step 4: Alpha testing The intervention underwent alpha testing where the intervention was taken to a wider stakeholder group for feedback. The writing group refined the intervention to reflect changes to current smoking cessation technology, including e-cigarettes and extended the intervention to be delivered up to 6 weeks post-birth. Step 5: Focus groups and user feedback Qualitative user testing was carried out the two health boards. The views of the target group were used to develop an intervention that was demonstrated to be feasible in practice and both acceptable and engaging for participants. Step 6: Refining texts and coding Text messages were refined based on the user feedback. The final text messages were coded for the presence of Behavioural Change Techniques (BCTs) by two coders. We have developed a narrative and image-based intervention delivering by text message with the aim of supporting smoking cessation in pregnant women. Importantly, the intervention is rooted in an in-depth understanding of the target group, and their needs. Trials registration ClinicalTrials.gov Protocol ID: RMS2119.

Introduction This research investigates how community-led organisations' (CLOs') use of assets-based approaches improves health and well-being, and how that might be different in different contexts. Assets-based approaches involve 'doing with' rather than 'doing to' and bring people in communities together to achieve positive change using their own knowledge, skills and experience. Some studies have shown that such approaches can have a positive effect on health and well-being. However, research is limited, and we know little about which approaches lead to which outcomes and how different contexts might affect success. Methods and analysis Using a realist approach, we will work with 15 CLOs based in disadvantaged communities in England, Scotland and Northern Ireland. A realist synthesis of review papers, and a policy analysis in different contexts, precedes qualitative interviews and workshops with stakeholders, to find out how CLOs' programmes work and identify existing data. We will explore participants' experiences through: a Q methodology study; participatory photography workshops; qualitative interviews and measure outcomes using a longitudinal survey, with 225 CLO participants, to assess impact for people who connect with the CLOs. An economic analysis will estimate costs and benefits to participants, for different contexts and mechanisms. A 'Lived Experience Panel' of people connected with our CLOs as participants or volunteers, will ensure the appropriateness of the research, interpretation and reporting of findings. Ethics and dissemination This project, research tools and consent processes have been approved by the Glasgow Caledonian University School of Health and Life Sciences Ethics Committee, and affirmed by Ethics Committees at Bournemouth University, Queen's University Belfast and the University of East London. Common Health Assets does not involve any National Health Service sites, staff or patients. Findings will be presented through social media, project website, blogs, policy briefings, journal articles, conferences and visually in short digital stories, and photographic exhibitions.

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 statis-tically 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 pound (SE 581 pound, 95% CI -576 pound to 1704) pound. 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.

INTRODUCTION AND HYPOTHESIS:Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse. METHODS:A total of 1348 women undergoing primary transvaginal repair of an anterior and/or posterior prolapse were recruited between January 2010 and August 2013 from 35 UK centres. They were randomised by remote allocation to native tissue surgery, biological xenograft or polypropylene mesh. We performed both 4- and 6-year follow-up using validated patient-reported outcome measures. RESULTS:At 4 and 6 years post-operation, there was no clinically important difference in Pelvic Organ Prolapse Symptom Score for any of the treatments. Using a strict composite outcome to assess functional cure at 6 years, we found no difference in cure among the three types of surgery. Half the women were cured at 6 years but only 10.3 to 12% of women had undergone further surgery for prolapse. However, 8.4% of women in the mesh group had undergone further surgery for mesh complications. There was no difference in the incidence of chronic pain or dyspareunia between groups. CONCLUSIONS:At the mid-term outcome of 6 years, there is no benefit from augmenting primary prolapse repairs with polypropylene mesh inlays or biological xenografts. There was no evidence that polypropylene mesh inlays caused greater pain or dyspareunia than native tissue repairs.

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.

Conducting economic evaluations alongside randomised controlled trials (RCTs) is an efficient way to collect cost-effectiveness data. Generic preference-based measures, such as EQ-5D, are often used alongside clinical data measures in RCTs. However, in the case of female urinary incontinence (UI), evidence of the relative performance of EQ-5D with condition-specific measures such as the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), measuring severity of UI, and Pelvic Organ Prolapse Symptom Score (POP-SS), measuring severity of prolapse symptoms, is limited. This study employed secondary analysis of outcome measures data collected during the Optimal Pelvic floor muscle training for Adherence Long-term (OPAL) RCT, which compared biofeedback-mediated pelvic floor muscle training to basic pelvic floor muscle training for women with UI. The relative performance of EQ-5D-3L and ICIQ-UI SF, and EQ-5D-3L and POP-SS was assessed for concurrent validity and known-groups validity. Data for 577 women (mean age 48) were available for EQ-5D-3L/ICIQ-UI SF, and 555 women (mean age 47) for EQ-5D-3L/POP-SS. Overall, EQ-5D-3L exhibited very weak association with the ICIQ-UI SF total score, or any subscale. EQ-5D-3L and POP-SS were found to be weakly correlated. EQ-5D-3L was able to distinguish between groups with known differences in severity of UI and also between types of UI. These findings provide useful information to guide researchers in selecting appropriate outcome measures for use in future clinical trials.

INTRODUCTION:Parkinson's disease is the second most common chronic neurodegenerative condition with bladder dysfunction affecting up to 71%. Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence. Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson's UK.OBJECTIVES:Conduct a randomised controlled trial (RCT) targeting people with Parkinson's disease (PwP) who have self-reported problematic lower urinary tract symptoms, investigating the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS. Implement a standardised training approach and package for the correct application of TTNS. Conduct a cost-effectiveness analysis of TTNS compared with sham TTNS.METHODS AND ANALYSIS:An RCT of 6 weeks with twice weekly TTNS or sham TTNS. Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system, and will be shown how to apply TTNS or sham TTNS. Participants will receive a weekly telephone call from the researchers during the intervention period. The trial has two coprimary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score. Secondary outcomes include a 3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation. Outcomes will be measured at 0, 6 and 12 weeks.A sample size of 208 randomised in equal numbers to the two arms will provide 90% power to detect a clinically important difference of 2.52 points on the Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score at 12 weeks at 5% significance level, based on an SD of 4.7 in each arm and 20% attrition at 6 weeks. Analysis will be by intention to treat and pre defined in a statistical analysis plan ETHICS AND DISSEMINATION: East of Scotland Research Ethics Service (EoSRES), 18/ES00042, obtained on 10 May 2018. The trial will allow us to determine effectiveness, safety, cost and acceptability of TTNS for bladder dysfunction in PWP. Results will be published in open access journals; lay reports will be posted to all participants and presented at conferences.TRIAL REGISTRATION NUMBER:ISRCTN12437878; Pre-results.

Objective: Smoking during pregnancy causes risks to mother and infant health. We investigated the feasibility and likely success of SKIP-IT, a narrative and picture-based smoking cessation intervention delivered via text messages.Methods: A feasibility and pilot trial. We aimed to recruit 70 pregnant women who smoked, randomised to usual care alone, or usual care and the SKIP-IT intervention, between 12 weeks of pregnancy and 6 weeks post due-date. Outcomes assessed were recruitment, retention, acceptability of, and engagement with the intervention, smoking behaviour, intentions, perceived risk, and self-efficacy. Results: Of 312 women initially approached by smoking cessation services only 54 (17%) agreed to be contacted by the research team. Twenty were then either ineligible or uncontactable and 28 (82%) participated. Most women reported texts to be entertaining and helpful. The proportion of women not smoking at follow-up was lower in the intervention group, but numbers were too small to draw conclusions about effectiveness.Conclusion: The intervention was acceptable, but difficulty in making initial and follow-up contacts meant our methods were unfeasible for a larger trial. Practice implications: Digital Storytelling interventions could help women quit smoking, but further research is required to identify alternative methods for studies with pregnant women who smoke.Crown Copyright (c) 2022 Published by Elsevier B.V. CC_BY_NC_ND_4.0

Pelvic organ prolapse affects around 40% of women aged over 50 years. A multicentre parallel group randomised trial (the Pelvic Organ Prolapse PhysiotherapY (POPPY) trial) demonstrated that pelvic floor muscle training (PFMT) was effective in reducing prolapse symptoms compared with no treatment. However, insight into the long-term impact of PFMT on health outcomes and health-service utilisation is scarce. This study utilised linkage of Scottish administrative health records to follow-up POPPY trial participants resident in Scotland over 11 years. Mixed effects logistic regression determined the likelihood of receiving further prolapse treatment for those in the PFMT and control groups. Analyses were adjusted for age group, prolapse stage, baseline symptom severity and attitude towards surgery. A cost assessment estimated longitudinal costs to the UK National Health Service (in Scotland) of accessing further prolapse treatment for each trial group. Two hundred and ninety-three women, aged 25 to 79 years, were followed up. One hundred and forty-one women (48.1%) had received further prolapse treatment: 65 (of 149; 43.6%) in the PFMT group compared with 76 (of 144; 52.8%) in the control group. PFMT was associated with a reduction in the odds of any prolapse treatment during follow-up (AOR 0.61; 95% CI 0.37 to 0.99). Total cost of secondary care was £154,544 (GBP) in the PFMT group and £172,549 (GBP) in the control group. Although PFMT did not lead to significant differences in total costs for further prolapse treatment over a post-intervention period of more than 10 years, it reduced the overall long-term risk of requiring hospital-based treatment for pelvic floor disorders.