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.

'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.

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.

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.

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.

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.

Factors affecting continuation of clean intermittent catheterisation in people with multiple sclerosis: Results of the COSMOS mixed-methods study.

BACKGROUND: Clean intermittent catheterisation (CIC) is often recommended for people with multiple sclerosis (MS). OBJECTIVE: To determine the variables that affect continuation or discontinuation of the use of CIC. METHODS: A three-part mixed-method study (prospective longitudinal cohort ( n = 56), longitudinal qualitative interviews ( n = 20) and retrospective survey ( n = 456)) was undertaken, which identified the variables that influenced CIC continuation/discontinuation. The potential explanatory variables investigated in each study were the individual's age, gender, social circumstances, number of urinary tract infections, bladder symptoms, presence of co-morbidity, stage of multiple sclerosis and years since diagnosis, as well as CIC teaching method and intensity. RESULTS: For some people with MS the prospect of undertaking CIC is difficult and may take a period of time to accept before beginning the process of using CIC. Ongoing support from clinicians, support at home and a perceived improvement in symptoms such as nocturia were positive predictors of continuation. In many cases, the development of a urinary tract infection during the early stages of CIC use had a significant detrimental impact on continuation. CONCLUSION: Procedures for reducing the incidence of urinary tract infection during the learning period (i.e. when being taught and becoming competent) should be considered, as well as the development of a tool to aid identification of a person's readiness to try CIC.

Women's experiences of receiving care for pelvic organ prolapse: a qualitative study.

BACKGROUND: Pelvic organ prolapse is a common urogenital condition affecting 41-50% of women over the age of 40. To achieve early diagnosis and appropriate treatment, it is important that care is sensitive to and meets women's needs, throughout their patient journey. This study explored women's experiences of seeking diagnosis and treatment for prolapse and their needs and priorities for improving person-centred care. METHODS: Twenty-two women receiving prolapse care through urogynaecology services across three purposefully selected NHS UK sites took part in three focus groups and four telephone interviews. A topic guide facilitated discussions about women's experiences of prolapse, diagnosis, treatment, follow-up, interactions with healthcare professionals, overall service delivery, and ideals for future services to meet their needs. Data were analysed thematically. RESULTS: Three themes emerged relating to women's experiences of a) Evaluating what is normal b) Hobson's choice of treatment decisions, and c) The trial and error of treatment and technique. Women often delayed seeking help for their symptoms due to lack of awareness, embarrassment and stigma. When presented to GPs, their symptoms were often dismissed and unaddressed until they became more severe. Women reported receiving little or no choice in treatment decisions. Choices were often influenced by health professionals' preferences which were subtly reflected through the framing of the offer. Women's embodied knowledge of their condition and treatment was largely unheeded, resulting in decisions that were inconsistent with women's preferences and needs. Physiotherapy based interventions were reported as helping women regain control over their symptoms and life. A need for greater awareness of prolapse and physiotherapy interventions among women, GPs and consultants was identified alongside greater focus on prevention, early diagnosis and regular follow-up. Greater choice and involvement in treatment decision making was desired. CONCLUSIONS: As prolapse treatment options expand to include more conservative choices, greater awareness and education is needed among women and professionals about these as a first line treatment and preventive measure, alongside a multi-professional team approach to treatment decision making. Women presenting with prolapse symptoms need to be listened to by the health care team, offered better information about treatment choices, and supported to make a decision that is right for them.

Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial.

BACKGROUND: Pelvic floor muscle training can reduce prolapse severity and symptoms in women seeking treatment. We aimed to assess whether this intervention could also be effective in secondary prevention of prolapse and the need for future treatment. METHODS: We did this multicentre, parallel-group, randomised controlled trial at three centres in New Zealand and the UK. Women from a longitudinal study of pelvic floor function after childbirth were potentially eligible for inclusion. Women of any age who had stage 1-3 prolapse, but had not sought treatment, were randomly assigned (1:1), via remote computer allocation, to receive either one-to-one pelvic floor muscle training (five physiotherapy appointments over 16 weeks, and annual review) plus Pilates-based pelvic floor muscle training classes and a DVD for home use (intervention group), or a prolapse lifestyle advice leaflet (control group). Randomisation was minimised by centre, parity (three or less vs more than three deliveries), prolapse stage (above the hymen vs at or beyond the hymen), and delivery method (any vaginal vs all caesarean sections). Women and intervention physiotherapists could not be masked to group allocation, but allocation was masked from data entry researchers and from the trial statistician until after database lock. The primary outcome was self-reported prolapse symptoms (Pelvic Organ Prolapse Symptom Score [POP-SS]) at 2 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01171846. FINDINGS: Between Dec 21, 2008, and Feb 24, 2010, in New Zealand, and Oct 27, 2010, and Sept 5, 2011, in the UK, we randomly assigned 414 women to the intervention group (n=207) or the control group (n=207). One participant in each group was excluded after randomisation, leaving 412 women for analysis. At baseline, 399 (97%) women had prolapse above or at the level of the hymen. The mean POP-SS score at 2 years was 3·2 (SD 3·4) in the intervention group versus 4·2 (SD 4·4) in the control group (adjusted mean difference -1·01, 95% CI -1·70 to -0·33; p=0·004). The mean symptom score stayed similar across time points in the control group, but decreased in the intervention group. Three adverse events were reported, all of which were in the intervention group (one women had a fall, one woman had a pain in her tail bone, and one woman had chest pain and shortness of breath). INTERPRETATION: Our study shows that pelvic floor muscle training leads to a small, but probably important, reduction in prolapse symptoms. This finding will be important for women and caregivers considering preventive strategies. FUNDING: Wellbeing of Women charity, the New Zealand Continence Association, and the Dean's Bequest Fund of Dunedin School of Medicine.

International Continence Society supported pelvic physiotherapy education guideline.

AIM: To provide a guideline of desired knowledge, clinical skills and education levels in Pelvic Physiotherapy (PT). Physiotherapy (PT) involves "using knowledge and skills unique to physiotherapists" and, "is the service only provided by, or under the direction and supervision of a physiotherapist."1 METHODS: The PT Committee, within the body of the International Continence Society (ICS), collected information regarding existing educational levels for pelvic floor PT. Through face to face and on on-line discussion consensus was reached which was summarized in three progressive educational levels based on knowledge and skills and brought together in a guideline. The guideline was submitted to all physiotherapists and the Educational Committee of the ICS, and after approval, submitted to the Executive Board of the ICS. RESULT: The guideline lists, in a progressive way, knowledge areas and skills to be achieved by education. It is broad and allows for individual interpretation based on local situations regarding education and healthcare possibilities. It is intended to be dynamic and updated on a regular basis. CONCLUSION: The proposed Pelvic PT education guideline is a dynamic document that allows course creators to plan topics for continuing course work and to recognize educational level of a therapist in the field of Pelvic PT. This education guideline can be used to set minimum worldwide standards resulting in higher skill levels for local pelvic physiotherapists and thereby better patient care outcome.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction.

Introduction and hypothesis There has been an increasing need for the terminology on the conservative management of female pelvic floor dysfunction to be collated in a clinically based consensus report. Methods This Report combines the input of members and elected nominees of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS), assisted at intervals by many external referees. An extensive process of nine rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). Before opening up for comments on the webpages of ICS and IUGA, five experts from physiotherapy, neurology, urology, urogynecology, and nursing were invited to comment on the paper. Results A Terminology Report on the conservative management of female pelvic floor dysfunction, encompassing over 200 separate definitions, has been developed. It is clinically based, with the most common symptoms, signs, assessments, diagnoses, and treatments defined. Clarity and ease of use have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in female pelvic floor dysfunction. Ongoing review is not only anticipated, but will be required to keep the document updated and as widely acceptable as possible. Conclusion A consensus-based terminology report for the conservative management of female pelvic floor dysfunction has been produced, aimed at being a significant aid to clinical practice and a stimulus for research.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction.

INTRODUCTION AND HYPOTHESIS: There has been an increasing need for the terminology on the conservative management of female pelvic floor dysfunction to be collated in a clinically based consensus report. METHODS: This Report combines the input of members and elected nominees of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS), assisted at intervals by many external referees. An extensive process of nine rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). Before opening up for comments on the webpages of ICS and IUGA, five experts from physiotherapy, neurology, urology, urogynecology, and nursing were invited to comment on the paper. RESULTS: A Terminology Report on the conservative management of female pelvic floor dysfunction, encompassing over 200 separate definitions, has been developed. It is clinically based, with the most common symptoms, signs, assessments, diagnoses, and treatments defined. Clarity and ease of use have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in female pelvic floor dysfunction. Ongoing review is not only anticipated, but will be required to keep the document updated and as widely acceptable as possible. CONCLUSION: A consensus-based terminology report for the conservative management of female pelvic floor dysfunction has been produced, aimed at being a significant aid to clinical practice and a stimulus for research.

What Adherence Measures Should Be Used in Trials of Home-Based Rehabilitation Interventions? A Systematic Review of the Validity, Reliability, and Acceptability of Measures.

OBJECTIVE: To systematically review methods for measuring adherence used in home-based rehabilitation trials and to evaluate their validity, reliability, and acceptability. DATA SOURCES: In phase 1 we searched the CENTRAL database, NHS Economic Evaluation Database, and Health Technology Assessment Database (January 2000 to April 2013) to identify adherence measures used in randomized controlled trials of allied health professional home-based rehabilitation interventions. In phase 2 we searched the databases of MEDLINE, Embase, CINAHL, Allied and Complementary Medicine Database, PsycINFO, CENTRAL, ProQuest Nursing and Allied Health, and Web of Science (inception to April 2015) for measurement property assessments for each measure. STUDY SELECTION: Studies assessing the validity, reliability, or acceptability of adherence measures. DATA EXTRACTION: Two reviewers independently extracted data on participant and measure characteristics, measurement properties evaluated, evaluation methods, and outcome statistics and assessed study quality using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. DATA SYNTHESIS: In phase 1 we included 8 adherence measures (56 trials). In phase 2, from the 222 measurement property assessments identified in 109 studies, 22 high-quality measurement property assessments were narratively synthesized. Low-quality studies were used as supporting data. StepWatch Activity Monitor validly and acceptably measured short-term step count adherence. The Problematic Experiences of Therapy Scale validly and reliably assessed adherence to vestibular rehabilitation exercises. Adherence diaries had moderately high validity and acceptability across limited populations. The Borg 6 to 20 scale, Bassett and Prapavessis scale, and Yamax CW series had insufficient validity. Low-quality evidence supported use of the Joint Protection Behaviour Assessment. Polar A1 series heart monitors were considered acceptable by 1 study. CONCLUSIONS: Current rehabilitation adherence measures are limited. Some possess promising validity and acceptability for certain parameters of adherence, situations, and populations and should be used in these situations. Rigorous evaluation of adherence measures in a broader range of populations is needed.

PROPEL: implementation of an evidence based pelvic floor muscle training intervention for women with pelvic organ prolapse: a realist evaluation and outcomes study protocol.

BACKGROUND: Pelvic Organ Prolapse (POP) is estimated to affect 41%-50% of women aged over 40. Findings from the multi-centre randomised controlled "Pelvic Organ Prolapse PhysiotherapY" (POPPY) trial showed that individualised pelvic floor muscle training (PFMT) was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. However, provision of PFMT for prolapse continues to vary across the UK, with limited numbers of women's health physiotherapists specialising in its delivery. Implementation of this robust evidence from the POPPY trial will require attention to different models of delivery (e.g. staff skill mix) to fit with differing care environments. METHODS: A Realist Evaluation (RE) of implementation and outcomes of PFMT delivery in contrasting NHS settings will be conducted using multiple case study sites. Involving substantial local stakeholder engagement will permit a detailed exploration of how local sites make decisions on how to deliver PFMT and how these lead to service change. The RE will track how implementation is working; identify what influences outcomes; and, guided by the RE-AIM framework, will collect robust outcomes data. This will require mixed methods data collection and analysis. Qualitative data will be collected at four time-points across each site to understand local contexts and decisions regarding options for intervention delivery and to monitor implementation, uptake, adherence and outcomes. Patient outcome data will be collected at baseline, six months and one year follow-up for 120 women. Primary outcome will be the Pelvic Organ Prolapse Symptom Score (POP-SS). An economic evaluation will assess the costs and benefits associated with different delivery models taking account of further health care resource use by the women. Cost data will be combined with the primary outcome in a cost effectiveness analysis, and the EQ-5D-5L data in a cost utility analysis for each of the different models of delivery. DISCUSSION: Study of the implementation of varying models of service delivery of PFMT across contrasting sites combined with outcomes data and a cost effectiveness analysis will provide insight into the implementation and value of different models of PFMT service delivery and the cost benefits to the NHS in the longer term.

Abdominal massage for the alleviation of symptoms of constipation in people with Parkinson's: a randomised controlled pilot study.

BACKGROUND: constipation is one of the most common non-motor features of Parkinson's affecting up to 90% of patients. In severe cases, it can lead to hospitalisation and is usually managed with laxatives which in themselves can lead to side effects. Abdominal massage has been used as adjunct in the management of constipation in various populations, but not in those with Parkinson's. OBJECTIVE: the primary objective was to test the recruitment, retention and the appropriateness of the intervention methods and outcome measures. METHODS: thirty-two patients with Parkinson's were recruited from three movement disorder clinics and were randomised to receive either 6 weeks of daily abdominal massage plus lifestyle advice on managing constipation (Intervention Group, n = 16) or lifestyle advice (Control Group, n = 16). Data were collected prior to group allocation (Baseline), at Week 6 (following intervention) and 4 weeks later (Week 10). Outcome tools included the Gastrointestinal Rating Scale and a bowel diary. RESULTS: constipation has a negative impact on quality of life. The study recruited to target, retention was high and adherence to the study processes was good. The massage was undertaken as recommended during the 6 weeks of intervention with 50% continuing with the massage at 10 weeks. Participants in both groups demonstrated an improvement in symptoms, although this was not significantly different between the groups. CONCLUSION: abdominal massage, as an adjunct to management of constipation, offers an acceptable and potentially beneficial intervention to patients with Parkinson's.

Health professionals' and patients' perspectives on pelvic floor muscle training adherence-2011 ICS State-of-the-Science Seminar research paper IV of IV.

AIMS: There is scant information on pelvic floor muscle training (PFMT) adherence barriers and facilitators. A web-based survey was conducted (1) to investigate whether responses from health professionals and the public broadly reflected findings in the literature, (2) if responses differed between the two groups, and (3) to identify new research directions. METHODS: Health professional and public surveys were posted on the ICS website. PFMT adherence barriers and facilitators were divided into four categories: physical/condition, patient, therapy, and social-economic. Responses were analyzed using descriptive statistics from quantitative data and thematic data analysis for qualitative data. RESULTS: Five hundred and fifteen health professionals and 51 public respondents participated. Both cohorts felt "patient-related factors" constituted the most important adherence barrier, but differed in their rankings of short- and long-term barriers. Health professionals rated "patient-related" and the public "therapy-related" factors as the most important adherence facilitator. Both ranked "perception of PFMT benefit" as the most important long-term facilitator. Contrary to published findings, symptom severity was not ranked highly. Neither cohort felt the barriers nor facilitators differed according to PFM condition (urinary/faecal incontinence, pelvic organ prolapse, pelvic pain); however, a large number of health professionals felt differences existed across age, gender, and ethnicity. Half of respondents in both cohorts felt research barriers and facilitators differed from those in clinical practice. CONCLUSIONS: An emphasis on "patient-related" factors, ahead of "condition-specific" and "therapy-related," affecting PFMT adherence barriers was evident. Health professionals need to be aware of the importance of long-term patient perception of PFMT benefits and consider enabling strategies.

Pelvic-floor-muscle-training adherence "modifiers": A review of primary qualitative studies-2011 ICS State-of-the-Science Seminar research paper III of IV.

AIMS: This review aims to locate and summarize the findings of qualitative studies exploring the experience of and adherence to pelvic floor muscle training (PFMT) to recommend future directions for practice and research. METHODS: Primary qualitative studies were identified through a conventional subject search of electronic databases, reference-list checking, and expert contact. A core eligibility criterion was the inclusion of verbatim quotes from participants about PFMT experiences. Details of study aims, methods, and participants were extracted and tabulated. Data were inductively grouped into categories describing "modifiers" of adherence (verified by a second author) and systematically displayed with supporting illustrative quotes. RESULTS: Thirteen studies (14 study reports) were included; eight recruited only or predominantly women with urinary incontinence, three recruited postnatal women, and two included women with pelvic organ prolapse. The quality of methodological reporting varied. Six "modifiers" of adherence were described: knowledge; physical skill; feelings about PFMT; cognitive analysis, planning, and attention; prioritization; and service provision. CONCLUSIONS: Individuals' experience substantial difficulties with capability (particularly knowledge and skills), motivation (especially associated with the considerable cognitive demands of PFMT), and opportunity (as external factors generate competing priorities) when adopting and maintaining a PFMT program. Expert consensus was that judicious selection and deliberate application of appropriate behavior change strategies directed to the "modifiers" of adherence identified in the review may improve PFMT outcomes. Future research is needed to explore whether the review findings are congruent with the PFMT experiences of antenatal women, men, and adults with fecal incontinence.

Scoping review of adherence promotion theories in pelvic floor muscle training - 2011 ICS state-of-the-science seminar research paper i of iv.

AIMS: This paper, the first of four emanating from the International Continence Society's 2011 State-of-the-Science Seminar on pelvic-floor-muscle training (PFMT) adherence, aimed to summarize the literature on theoretical models to promote PFMT adherence, as identified in the research, or suggested by the seminar's expert panel, and recommends future directions for clinical practice and research. METHODS: Existing literature on theories of health behavior were identified through a conventional subject search of electronic databases, reference-list checking, and input from the expert panel. A core eligibility criterion was that the study included a theoretical model to underpin adherence strategies used in an intervention to promote PFM training/exercise. RESULTS: A brief critique of 12 theoretical models/theories is provided and, were appropriate, their use in PFMT adherence strategies identified or examples of possible uses in future studies outlined. CONCLUSION: A better theoretical-based understanding of interventions to promote PFMT adherence through changes in health behaviors is required. The results of this scoping review and expert opinions identified several promising models. Future research should explicitly map the theories behind interventions that are thought to improve adherence in various populations (e.g., perinatal women to prevent or lessen urinary incontinence). In addition, identified behavioral theories applied to PFMT require a process whereby their impact can be evaluated.

Pelvic-Floor-Muscle Training Adherence: Tools, Measurements and Strategies-2011 ICS State-of-the-Science Seminar Research Paper II of IV.

AIMS: This paper on pelvic-floor-muscle training (PFMT) adherence, the second of four from the International Continence Society's 2011 State-of-the-Science Conference, aims to (1) identify and collate current adherence outcome measures, (2) report the determinants of adherence, (3) report on PFMT adherence strategies, and (4) make actionable clinical and research recommendations. METHOD: Data were amassed from a literature review and an expert panel (2011 conference), following consensus statement methodology. Experts in pelvic floor dysfunction collated and synthesized the evidence and expert opinions on PFMT adherence for urinary incontinence (UI) and lower bowel dysfunction in men and women and pelvic organ prolapse in women. RESULTS: The literature was scarce for most of the studied populations except for limited research on women with UI. OUTCOME MEASURES: Exercise diaries were the most widely-used adherence outcome measure, PFMT adherence was inconsistently monitored and inadequately reported. Determinants: Research, mostly secondary analyses of RCTs, suggested that intention to adhere, self-efficacy expectations, attitudes towards the exercises, perceived benefits and a high social pressure to engage in PFMT impacted adherence. STRATEGIES: Few trials studied and compared adherence strategies. A structured PFMT programme, an enthusiastic physiotherapist, audio prompts, use of established theories of behavior change, and user-consultations seem to increase adherence. CONCLUSION: The literature on adherence outcome measures, determinants and strategies remains scarce for the studied populations with PFM dysfunction, except in women with UI. Although some current adherence findings can be applied to clinical practice, more effective and standardized research is urgently needed across all the sub-populations.