The development of the Cystectomy-Pathway Assessment Tool (C-PAT): a concise tool to assess the quality of care in the cystectomy pathway.

OBJECTIVES: To develop and test the psychometric properties of a concise, patient-reported questionnaire, designed to assess key aspects of the radical cystectomy (RC) patient pathway that are important to both patients and clinicians. PATIENTS AND METHODS: Draft items were developed by a consultation with a 13-member expert clinical panel, and the in-depth qualitative analysis of 14 semi-structured interviews with patients who had received RC within the previous 18 months. A further nine cognitive interviews with patients refined the items and ensured they were easy to complete. Pilot testing in 122 patients recruited from five hospitals in England tested the properties of validity and reliability of the resulting 17-item questionnaire. RESULTS: Patients and clinicians identified the following aspects as important for the delivery of quality patient care. These included timely referral and initial test results; an explanation of risk/benefits of treatment; access to a cancer nurse specialist; training and support in stoma management; timely surgery, surgical complications, and timely follow-up. Pilot testing showed missing data was low (≤3% for all items), and between 73% and 89% of the responses to items were the most positive about their care (indicating ceiling effects). Five items were identified using factor analysis as being statistically related (Cronbach's α 0.76, intraclass correlation coefficient test-retest reliability of 0.95) and formed the scored part of the tool 'care and support', scored 0-16. There was insufficient evidence at this stage to show the tool was capable of measuring differences between cancer centres. CONCLUSION: We have developed a questionnaire that captures aspects of quality of care within the RC patient pathway. The results support the validity and reliability of the 17-item Cystectomy-Pathway Assessment Tool (C-PAT). We envisage the tool can be the basis for audit of the patient reported assessment of the quality of care for individual cancer centres.

Professional perspectives on impacts, benefits and disadvantages of changes made to community continence services during the COVID-19 pandemic: findings from the EPICCC-19 national survey.

BACKGROUND: The COVID-19 pandemic required changes to the organisation and delivery of NHS community continence services which assess and treat adults and children experiencing bladder and bowel difficulties. Although strong evidence exists for the physical and mental health benefits, improved quality of life, and health service efficiencies resulting from optimally organised community-based continence services, recent audits identified pre-pandemic pressures on these services. The aim of this study was to explore professional perceptions of changes made to community continence services due to the COVID-19 pandemic and consequent impacts on practice, care provision and patient experience. METHODS: Online survey of 65 community continence services in England. Thematic analysis using constant comparison of open-ended questions. Frequency counts of closed-ended questions. RESULTS: Sixty-five services across 34 Sustainability and Transformation Partnership areas responded to the survey. Use of remote/virtual consultations enabled continuation of continence care but aspects of 'usual' assessment (examinations, tests) could not be completed within a remote assessment, requiring professionals to decide which patients needed subsequent in-person appointments. Remote appointments could increase service capacity due to their time efficiency, were favoured by some patients for their convenience, and could increase access to care for others. However, the limited ability to complete aspects of usual assessment raised concerns that diagnoses could be missed, or inappropriate care initiated. The format also restricted opportunities to identify non-verbal cues that could inform professional interpretation; and made building a therapeutic relationship between professional and patient more challenging. Remote appointments also posed access challenges for some patient groups. A third of participating services had experienced staff redeployment, resulting in long wait times and some patients being left without care; or reported additional caseload, which had delayed care provision for patients with continence issues. Participants perceived continence care to have been deprioritised, and more generally undervalued, and called for greater recognition of the impact of continence care. CONCLUSIONS: Remote appointments offer efficiency and convenience. However, 'in-person' approaches are highly valued for optimum quality, patient-centred continence care, and good team relationships. Failure to restore redeployed continence staff will diminish patient health and quality of life, with associated costs to the NHS.

Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate for men with lower urinary tract symptoms or urinary retention (UNBLOCS): a randomised controlled trial.

BACKGROUND: Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction. Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. We aimed to investigate TURP versus ThuVARP in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction. METHODS: In this randomised, blinded, parallel-group, pragmatic equivalence trial, men in seven UK hospitals with bothersome lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction were randomly assigned (1:1) at the point of surgery to receive ThuVARP or TURP. Patients were masked until follow-up completion. Centres used their usual TURP procedure (monopolar or bipolar). All trial surgeons underwent training on the ThuVARP technique. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS) at 12-months post-surgery. Equivalence was defined as a difference of 2·5 points or less for IPSS and 4 mL per s or less for Qmax. Analysis was done according to the intention-to-treat principle. The trial is registered with the ISRCTN Registry, ISRCTN00788389. FINDINGS: Between July 23, 2014, and Dec 30, 2016, 410 men were randomly assigned to ThuVARP or TURP, 205 per study group. TURP was superior for Qmax (mean 23·2 mL per s for TURP and 20·2 mL per s for ThuVARP; adjusted difference in means -3·12, 95% CI -5·79 to -0·45). Equivalence was shown for IPSS (mean 6·3 for TURP and 6·4 for ThuVARP; adjusted difference in means 0·28, -0·92 to 1·49). Mean hospital stay was 48 h in both study groups. 91 (45%) of 204 patients in the TURP group and 96 (47%) of 203 patients in the ThuVARP group had at least one complication. INTERPRETATION: TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax. Anticipated laser benefits for ThuVARP of reduced hospital stay and complications were not observed. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

Grading Severity and Bother Using the International Prostate Symptom Score and International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Score in Men Seeking Lower Urinary Tract Symptoms Therapy.

PURPOSE: We established severity banding ranges, bother assessment and key item content in principal patient reported outcomes measures in men seeking therapy for lower urinary tract symptoms. MATERIALS AND METHODS: Data for International Prostate Symptom Score (I-PSS) and International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) were derived from a study evaluating 820 men at 26 United Kingdom hospitals. ROC curves were used to establish severity bandings. RESULTS: Classification tree showed that thresholds between mild-moderate and moderate-severe severity bands were 15 and 27 for I-PSS, 16 and 26 for ICIQ-MLUTS/severity, and 22 and 81 for ICIQ-MLUTS/bother, respectively. Highest area under the ROC curve and lowest Akaike's information criteria of univariate logistic regression indicated that ICIQ-MLUTS/bother was more related to global quality of life than were I-PSS and ICIQ-MLUTS/severity. The symptoms affecting I-PSS-quality of life (QoL) were only fully identified by ICIQ-MLUTS, because 2 key symptoms (urinary incontinence and post-micturition dribble) are not measured by I-PSS. ICIQ-MLUTS demonstrated that bother of some lower urinary tract symptoms is disproportionate to severity, and that persisting high bother levels following surgery are more likely due to storage (18% to 25%) and post-voiding (18% to 28%) lower urinary tract symptoms than voiding lower urinary tract symptoms (5% to 13%). Symptom improvement after surgery was uncertain if baseline I-PSS-QoL score was less than 3. CONCLUSIONS: The severity threshold scores were measured for the 2 key lower urinary tract symptoms patient reported outcomes measures, and the results indicate suitable categories of symptom severity for use in men referred for urological care. The ICIQ-MLUTS measures all the lower urinary tract symptoms affecting quality of life and includes individual symptom bother scores.

International Consultation on Incontinence Questionnaire-Satisfaction: psychometric testing of a new patient-reported outcome measure for the evaluation of satisfaction after urological surgery.

OBJECTIVES: To evaluate the psychometric properties of a new patient-reported outcome measure (PROM), the International Consultation on Incontinence Questionnaire-Satisfaction (ICIQ-S), to assess satisfaction after urological surgery. SUBJECTS/PATIENTS AND METHODS: Following item development, the developmental ICIQ-S (dICIQ-S) was used within in a randomised control trial comparing two types of surgery for male prostatic obstruction at 1.5, 3, and 12 months after surgery. Reliability was assessed by Cronbach's α and construct validity by the correlation of scores with concurrently administered PROMs of known validity: ICIQ-Male Lower Urinary Tract Symptoms (LUTS), International Prostate Symptom Score, and the ICIQ-LUTS Quality of Life. RESULTS: A total of 410 men were included in the trial. Missing data was generally low for the dICIQ-S [mean (range) 1.6 (<1-3.1)%] except for the items 'complications' 6.8% and 'satisfaction with sex-life' 9.2%. High ceiling effects were found in all items. Factor analysis identified six items related to surgical outcomes (Cronbach's α 0.89), which have formed the scored part of the ICIQ-S, together with a standalone overall satisfaction item, scored 0-10. Seven additional unscored items, related to satisfaction with experiences and expectations, were also retained. As hypothesised, post-surgery dICIQ-S scores were correlated with reduced symptoms and improved quality of life as measured by the concurrent PROMs. CONCLUSION: The results support the validity and reliability of a scored six-item domain for evaluating satisfaction with surgical outcomes, together with a standalone scored overall satisfaction item. The further unscored seven standalone items are anticipated to be used as the basis for adaptation and further validation of the ICIQ-S in different patient populations.

The International Consultation on Incontinence Questionnaires (ICIQ): An update on status and direction.

AIMS: In its 22nd year, the International Consultation on Incontinence Questionnaire (ICIQ) project continues to promote its primary objective; the development and dissemination of patient completed questionnaires for the standardized, high-quality assessment of urinary, bowel, and vaginal symptoms. The paper gives an update on the ICIQ in the context of current scientific developments of PROM design and regulatory requirements, and plans are outlined for its future direction. METHODS: An online library of all questionnaires, including over 300 translations has been launched to facilitate access through a semi-automated registration system. The ICIQ project continues to update its protocol to meet current scientific standards and incorporate methodological advances within PROM development. RESULTS: Nineteen psychometrically validated patient-reported outcome measures (PROMs) are published for use in clinical practice and research, including amongst others, a bladder diary, male and female lower urinary tract symptoms, long term catheter, pad use, and bowel symptom questionnaires. The original ICIQ-UI Short Form for the assessment of urinary incontinence continues to be the most internationally used questionnaire and has been translated into over 60 languages. New questionnaires which are under development include the ICIQ-Underactive Bladder and ICIQ-Satisfaction. We anticipate the new website and online library will further facilitate the ease of dissemination and availability of the questionnaires for clinical practice and research. CONCLUSION: The ICIQ continues to successfully achieve its primary objective. Going forward, a greater focus on promoting routine clinical use and the potential for electronic integration into databases and medical records is envisaged.

The development of the ICIQ-UAB: A patient reported outcome measure for underactive bladder.

AIMS: To present the development of the International Consultation on Incontinence Questionnaire-underactive bladder (ICIQ-UAB) as the first patient reported outcome measure for the assessment of the symptoms and impact on the health-related quality of life of UAB developed in-line with the Food and Drug Administration Guidance for Industry. METHODS: Draft items were developed following 44 semi-structured concept elicitation interviews in the UK and refined using 36 cognitive interviews. A pilot study was designed to assess the draft ICIQ-UAB's initial psychometric properties with 54 patients recruited from European hospitals. Further concept elicitation interviews were also carried out with 11 patients in the US and 10 patients in Japan. All participants had a prior urodynamic diagnosis of detrusor underactivity. RESULTS: The cognitive interviews confirmed the initial items to be understood and interpreted as intended. Pilot testing showed that both internal consistency (Cronbach's α ≥ 0.85) and test-retest reliability (stable patients; intraclass correlation coefficient ≥ 0.88) were high. The interviews in the US and Japan elicited symptoms and impacts that support previous findings in the UK and provided further insight into the experiences of patients in those countries. The developmental ICIQ-UAB was refined using the evidence from all substudies. CONCLUSIONS: The validity and reliability of the ICIQ-UAB were supported in a pilot study setting and the wider cultural applicability by the additional interviews in the US and Japan. Following further validation in future clinical trials, the developmental ICIQ-UAB is envisaged as an important tool for the monitoring of future UAB treatment strategies.

Results of a randomized, double blind, placebo controlled, crossover trial of melatonin for treatment of Nocturia in adults with multiple sclerosis (MeNiMS).

BACKGROUND: Nocturia is a common urinary symptom of multiple sclerosis (MS) which can affect quality of life (QoL) adversely. Melatonin is a hormone known to regulate circadian rhythm and reduce smooth muscle activity such as in the bladder. There is limited evidence supporting use of melatonin to alleviate urinary frequency at night in the treatment of nocturia. The aim of this study was to evaluate the effect of melatonin on the mean number of nocturia episodes per night in patients with MS. METHODS: A randomized, double blind, placebo controlled crossover trial was conducted. 34 patients with nocturia secondary to multiple sclerosis underwent a 4-day pre-treatment monitoring phase. The patients were randomized to receive either 2 mg per night (taken at bedtime) of capsulated sustained-release melatonin (Circadin®) or 1 placebo capsule for 6 weeks followed by a crossover to the other regimen for an additional 6 weeks after a 1-month washout period. RESULTS: From the 26 patients who completed the study, there was no significant difference observed in the signs or symptoms of nocturia when taking 2 mg melatonin compared to placebo. The primary outcome measure, mean number of nocturia episodes on bladder diaries, was 1.8/night at baseline, and 1.4/night on melatonin, compared with 1.6 for placebo (Medians 1.70, 1.50, and 1.30 respectively, p = 0.85). There was also no significant difference seen in LUTS, QoL and sleep quality when taking melatonin. No significant safety concerns arose. CONCLUSIONS: This small study suggests that a low dose of melatonin taken at bedtime may be ineffective therapy for nocturia in MS. TRIAL REGISTRATION: (EudraCT reference) 2012-00418321 registered: 25/01/13. ISRCTN Registry: ISRCTN38687869 .

Development and psychometric evaluation of ICIQ-PadPROM: A quality of life questionnaire to assess the treatment effect of absorbent continence products.

AIM: To describe the development and evaluation of the ICIQ-PadPROM, the first self-reported quality of life questionnaire to assess the treatment effect of absorbent continence products, a new addition to the set of ICIQ modules providing international standardized assessment of lower pelvic dysfunction. METHODS: Developed in four phases, question items semi-structured interviews were conducted with pad using men (n = 19), women (n = 6), with secondary analysis undertaken on transcripts (n = 15 women) from a previous study. Validity of a draft 67 item questionnaire was tested through cognitive debriefing interviews (n = 34) and postal survey (n = 239). Reliability was evaluated by 65 users with a 3 week interval between completions. Expert opinion and factor analysis were used to reduce the final questionnaire to 17 scored and 3 unscored items. RESULTS: The questionnaire comprises four scored domains: Pad design and Physical Effects (seven items), Psychological Effects (four items), Social Effects and Pad Leakage (three items) and Burden of Pad Use (three items), plus three unscored items. Levels of missing data ranged from 0 to 7.6%, with fair-to-moderate agreement. The Cronbach's alpha coefficient for all question items was 0.91 and factor analysis was undertaken to reduce redundancy. CONCLUSION: Existing incontinence-related outcome tools measure change in symptoms and quality of life impact. The ICIQ PadPROM questionnaire is the first to measure the impact of absorbent continence products on quality of life in the absence of any change in symptoms and will help policy-makers, clinicians, industry, and researchers to evaluate different products designs and materials for different patient populations.

Neurogenic bowel dysfunction: Clinical management recommendations of the Neurologic Incontinence Committee of the Fifth International Consultation on Incontinence 2013.

BACKGROUND: Evidence-based guidelines for the management of neurological disease and lower bowel dysfunction have been produced by the International Consultations on Incontinence (ICI). These are comprehensive guidelines, and were developed to have world-wide relevance. AIMS: To update clinical management of neurogenic bowel dysfunction from the recommendations of the 4th ICI, 2009. MATERIALS AND METHODS: A series of evidence reviews and updates were performed by members of the working group. The resulting guidelines were presented at the 2012 meeting of the European Association of Urology for consultation, and modifications applied to deliver evidence based conclusions and recommendations for the scientific report of the 5th edition of the ICI in 2013. RESULTS: The current review is a synthesis of the conclusions and recommendations, including the algorithms for initial and specialized management of neurogenic bowel dysfunction. The pathophysiology is described in terms of spinal cord injury, multiple sclerosis, and Parkinson's disease. Assessment requires detailed history and clinical assessment, general investigations, and specialized testing, if required. Treatment primarily focuses on optimizing stool consistency and regulating bowel evacuation to improve quality of life. Symptom management covers conservative and interventional measures to promote good habits and assist stool evacuation, along with prevention of incontinence. Education is essential to achieving optimal bowel management. DISCUSSION: The review offers a pragmatic approach to management in the context of complex pathophysiology and varied evidence base.

Can a patient reported outcome be adequate without assessing quality of life in lower urinary tract dysfunction?

AIMS AND METHODS: A think tank was convened at the sixth ICI-RS meeting held in the United Kingdom on September 2015, to consider the adequacy of patient reported outcome (PRO) measurement if quality of life (QoL) evaluation were excluded. Rigorous methodology is proposed for the development of PROs and much is written about this process but the necessity for QoL inclusion is rarely discussed. The decision was therefore taken to consider what QoL evaluation provides and what these data provide. RESULTS: Discussions highlighted the need to question our aim for including QoL evaluation in clinical practice and research, in order to ensure its necessity for the intended purpose. Improved understanding of the usefulness of QoL data, in particular in relation to important health indicators was also identified as an area of unmet need. CONCLUSIONS: The think tank ended with a collaborative research proposal to pool existing QoL databases to explore the correlations with other outcome measures and types of associations present. It was suggested that these findings would enable clinicians and researchers to make more informed decisions regarding PRO selection, use, and intepretation.

Psychometric equivalence of electronic and telephone completion of the ICIQ modules.

AIMS: To assess the equivalence of touch-screen (hand-held iPad) and telephone completion of patient-completed International Consultation on Incontinence Questionnaire (ICIQ) modules by comparison with corresponding data collected using conventional paper-and-pencil methods. METHODS: Men and women, attending urology outpatients complaining of LUTS, were randomised to one of three groups which determined the order in which they completed three administrations of the same questionnaire: paper, iPad and telephone. Four ICIQ questionnaires were evaluated: ICIQ-MLUTS, ICIQ-LUTSqol, ICIQ-OABqol and ICIQ-UI SF. RESULTS: From August 2012 to October 2014 a total of 448 out of 491 (91%) recruits completed the first two administrations and were included in the analysis. Three hundred forty-eight out of 491 (71%) completed the phone administration. The intra-class correlation coefficient (ICC) and Kappa statistic were calculated where appropriate between completed pairs of administrations. Mean ICC correlations were high (>0.8) between paper and iPad administrations. Paired paper and phone administrations were less well correlated, although still high (mean ICC>0.75). This may be partly due to the practical limitation that the phone interview was completed up to a week later than the initial two administrations. There was no evidence that potential moderator effects (gender, age and experience with computers or touch screen devices) significantly affected overall reliability of scores between administrations. CONCLUSIONS: We can recommend the interchangeable use of ICIQ electronic or paper based questionnaires in a clinical or research setting. Self-report is preferable to telephone delivery where possible. Neurourol. Urodynam. 9999:XX-XX, 2016. © 2016 Wiley Periodicals, Inc.

Development of a core set of outcome measures for OAB treatment.

INTRODUCTION AND HYPOTHESIS: Standardized measures enable the comparison of outcomes across providers and treatments giving valuable information for improving care quality and efficacy. The aim of this project was to define a minimum standard set of outcome measures and case-mix factors for evaluating the care of patients with overactive bladder (OAB). METHODS: The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group (WG) of leading clinicians and patients to engage in a structured method for developing a core outcome set. Consensus was determined by a modified Delphi process, and discussions were supported by both literature review and patient input. RESULTS: The standard set measures outcomes of care for adults seeking treatment for OAB, excluding residents of long-term care facilities. The WG focused on treatment outcomes identified as most important key outcome domains to patients: symptom burden and bother, physical functioning, emotional health, impact of symptoms and treatment on quality of life, and success of treatment. Demographic information and case-mix factors that may affect these outcomes were also included. CONCLUSIONS: The standardized outcome set for evaluating clinical care is appropriate for use by all health providers caring for patients with OAB, regardless of specialty or geographic location, and provides key data for quality improvement activities and research.

Development and psychometric evaluation of the ICIQ-LTCqol: A self-report quality of life questionnaire for long-term indwelling catheter users.

AIMS: Long-term indwelling catheterisation may affect health related quality of life, but clinical assessment and monitoring of people with indwelling catheters is poorly recorded because there are no validated measures to capture these criteria. In this paper, we describe the development of the ICIQ-Long Term Catheter quality of life (ICIQ-LTCqol), one of the modules of the ICIQ series, an international project to standardise assessment of lower pelvic dysfunction: www.iciq.net. METHODS: In-depth interviews were conducted with 27 catheter-users and 4 informal carers and cognitive debriefing with a further 31 catheter-users and clinical experts to evaluate clarity and comprehensiveness. The draft 44 item questionnaire was then sent by post to 893 long-term catheter-users; the 370 completed questionnaires were used to test content validity, test re-test reliability and internal consistency (Cronbach α coefficient). Factor analysis alongside expert opinion was used to formulate the final questionnaire of 16 items. This was then sent by post to another 438 long-term catheter-users to evaluate domain scores. RESULTS: The final questionnaire consists of two scored domains: catheter function and concern (9 items) and lifestyle impact (3 items) and four standalone items, relating to pads, pain, sexual activity and bladder spasm. Levels of missing data are good (mean 3.6%) with moderate to good agreement and acceptable internal consistency (Cronbach's alpha 0.76 and 0.74 for each domain respectively), suggesting acceptability and stability of the questionnaire. CONCLUSION: The ICIQ-LTCqol is a psychometrically robust self-report questionnaire for the clinical assessment and evaluation of health related quality of life for long-term catheter users.

The impact of urinary incontinence on health-related quality of life (HRQoL) in a real-world population of women aged 45-60 years: results from a survey in France, Germany, the UK and the USA.

OBJECTIVE: To develop a clear understanding of the relationship between severity of urinary incontinence (UI) and health-related quality of life (HRQoL) and mental well-being in a population of women of working age with the requisite demands of a busy, active life. SUBJECTS AND METHODS: A survey of women with UI, aged between 45 and 60 years, was conducted via the internet in the UK, France, Germany and USA between 1 and 30 September 2013. Validated outcome measures were used to assess symptoms and the impact of UI on activities of daily life, HRQoL, and mental well-being: The International Consultation on Incontinence Modular Questionnaire Short Form; (ICIQ-UI Short Form); the ICIQ-Lower Urinary Tract Symptoms Quality of Life; (ICIQ-LUTSqol); the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). The relationships between UI, HRQoL and mental well-being were analysed using analyses of variance and regression. RESULTS: The survey was completed by 1203 women with UI with an average age of 52.7 years. Based upon responses to the ICIQ-UI Short Form about the amount of urine that leaks, respondents were categorised as having light (n = 1023, 87%), medium (n = 134, 11%), or severe UI (n = 20, 2%). The scores on the ICIQ-UI Short Form increased with severity [mean (sd) scores: light UI 7.9 (3.4), medium UI 13.8 (2.9), and severe UI 18.3 (3.9)], as did the impact on HRQoL, assessed using the ICIQ-LUTSqol [mean (sd) scores: light UI 30.6 (7.3), medium UI 41.0 (11.2), and severe UI 56.9 (17.6)]. Mental well-being decreased with severity of UI, the mean (se) WEMWBS scores were: light UI 48.3 (10.1), medium UI 44.5 (9.5), and severe UI 39.9 (16.2). CONCLUSION: In women with UI, aged 45-60 years, UI symptoms directly affect HRQoL, which subsequently impacts negatively on mental well-being.

Clinical Evaluation of a Prototype Underwear Designed to Detect Urine Leakage From Continence Pads.

PURPOSE: We evaluated the performance of prototype underwear designed to detect urine leakage from continence pads, their acceptability to users, and their effect on health-related quality of life and psychosocial factors. DESIGN: Prototype product evaluation. SUBJECTS AND SETTING: Participants were 81 women with an average age of 67 years (range, 32-98 years) recruited between October 2010 and February 2012 from outpatient clinics, general practice surgeries, community continence services, and through charities and networks. METHODS: The TACT3 project developed and manufactured a prototype undergarment designed to alert the wearer to a pad leak before it reaches outer clothing or furniture. The study was conducted in 2 stages: a pilot/feasibility study to assess general performance and a larger study to measure performance, acceptability to users, health-related quality of life, and psychosocial impact. Participants were asked to wear the prototype underwear for a period of 2 weeks, keeping a daily diary of leakage events for the first 7 days. They also completed validated instruments measuring lower urinary tract symptoms, health-related quality of life, and psychosocial impact. RESULTS: On average, 86% of the time participants were alerted to pad leakage events. More than 90% thought the prototype underwear was "good" or "OK" and that it would or could give them more confidence. Mean scores for the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form indicated no change in the level of symptoms reported before or after the intervention, and no significant changes in health-related quality of life status occurred, except improvement in for travel restrictions. Evaluation via the Psychosocial Impact of Assistive Devices Scale also indicated a positive impact. CONCLUSION: The prototype underwear evaluated in this study was effective and acceptable for 5 out of every 10 wearers. Findings also suggest that the prototype underwear is suitable for women of all ages, dress sizes, and continence severity.

CONfidence: Developing an app to promote bladder and bowel health.

The CONfidence app was developed to address an unmet need for access to self-help advice and information for bladder and bowel incontinence. The app was developed by the Bladder and Bowel CONfidence Health Integration Team and Expert Self Care and this paper describes the evolution of this innovation to empower patients and the public with bladder and bowel leakage. The app is intended to provide a proactive approach to continence promotion and not replace formal healthcare. Crucial steps were identified to ensuring this resource was accessible and understandable for the intended audience including: input from national clinical experts and individuals with lived experience to co-produce content, clear definition of scope, technical expertise in app development, clear language avoiding jargon or medical terms, credibility assurance and a strategic plan for dissemination. The app is free to download and will remain so to ensure evidence-based continence advice can be in the palm of all with a smartphone. The CONfidence app has been downloaded approaching 7000 times and is in use in 10 countries. A continual effort is required to share this resource as disclosure of these symptoms is shrouded in secrecy and many people could benefit from its content.

Identifying the key determinants of a community pharmacy based bladder and bowel service.

OBJECTIVES: Community pharmacies and their personnel present an opportunity to implement new services for bladder and bowel continence care. Underpinned by the COM-B model of capability (C), opportunity (O), motivation (M), Behaviour (B)), this study explored the opinions of healthcare staff and users of community pharmacy services, to inform the development of a new pharmacy bladder and bowel service (PBBS). METHODS: A qualitative design was adopted by conducting in-depth semi-structured interviews with pharmacy staff, users of community pharmacy services, bladder and bowel service staff, and professionals involved with commissioning services. A thematic analysis was used, and resulting themes were mapped onto the components of the COM-B model. RESULTS: A total of 27 participants were interviewed that represented the four groups of participants. A pro-active, protocolised PBBS was envisaged, involving targeted advice and provision of self-help materials, medication support, and referral/follow-up assessment as appropriate. Training programs for pharmacy staff, adequate funding/remuneration and information technology, awareness campaigns, policy support and guidance were identified as key behavioural targets for the success of a potential PBBS. Workforce time and capacity, service user embarrassment and stigma were potential barriers. CONCLUSIONS: The study identified a range of elements to be considered in the design and implementation of a successful PBBS. Informed by the evidence presented by this study, a multi-faceted approach to co-design the service will be required to ensure it is fit for purpose for all healthcare public and policy stakeholders.

The role of community pharmacy in the promotion of continence care: A systematic review.

OBJECTIVES: Community pharmacies are convenient healthcare settings which provide a wide range of services in addition to medicine supply. Continence care is an area where there is an opportunity for the implementation of new innovations to improve clinical and service outcomes. The objective was to systematically evaluate evidence for the effectiveness, safety, acceptability and key determinants of interventions for the promotion and implementation of continence care in the community pharmacy setting. METHODS: The protocol was registered in the International Prospective Register of Systematic Reviews database (PROSPERO: CRD42022322558). The databases Medline, Embase, PsycINFO and CINAHL were searched and supplemented by grey literature searches, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses checklist. In total, 338 titles and abstracts were screened, 20 studies underwent full-text screening and four studies met the inclusion criteria and underwent quality assessment. The results are reported narratively due to the heterogeneity of study designs. RESULTS: There was some evidence for the effectiveness of interventions, resulting in increased provision of consumer self-help advice and materials, referrals to other care providers, and an increase in staff knowledge and confidence in continence care. Evidence was inconclusive for clinical outcomes due to small sample sizes and poor follow-up rates. Acceptability of interventions to both pharmacy staff and consumers was generally positive with some frustrations with reimbursement procedures and time constraints. Facilitators of a successful pharmacy-based continence service are likely to include staff training, high-quality self-care resources, increased public awareness, and the establishment of effective referral pathways and appropriate reimbursement (of service providers). CONCLUSIONS: There is a paucity of evidence regarding the contribution of the community pharmacy sector to continence care. The development of a new pharmacy bladder and bowel service should involve patients, healthcare professionals and policy stakeholders to address the potential barriers and build upon the facilitators identified by this review. PATIENT SUMMARY: We identified research that had explored how community pharmacy (chemist) personnel might support people with continence problems (e.g. bladder and bowel leakage). Only four studies were identified, however, they reported that training for pharmacy personnel and providing self-help advice about continence can be successful and was well-received by patients.