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.

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.

Lower urinary tract symptoms in men: the TRIUMPH cluster RCT.

Background: Conservative therapies are recommended as initial treatment for male lower urinary tract symptoms. However, there is a lack of evidence on effectiveness and uncertainty regarding approaches to delivery. Objective: The objective was to determine whether or not a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for lower urinary tract symptoms to usual care. Design: This was a two-arm cluster randomised controlled trial. Setting: The trial was set in 30 NHS general practice sites in England. Participants: Participants were adult men (aged ≥ 18 years) with bothersome lower urinary tract symptoms. Interventions: Sites were randomised 1 : 1 to deliver the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions trial intervention or usual care to all participants. The TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions intervention comprised a standardised advice booklet developed for the trial from the British Association of Urological Surgeons' patient information sheets, with patient and expert input. Patients were directed to relevant sections by general practice or research nurses/healthcare assistants following urinary symptom assessment, providing the manualised element. The healthcare professional provided follow-up contacts over 12 weeks to support adherence to the intervention. Main outcome measures: The primary outcome was the validated patient-reported International Prostate Symptom Score 12 months post consent. Rather than the minimal clinically important difference of 3.0 points for overall International Prostate Symptom Score, the sample size aimed to detect a difference of 2.0 points, owing to the recognised clinical impact of individual symptoms. Results: A total of 1077 men consented to the study: 524 in sites randomised to the intervention arm (n = 17) and 553 in sites randomised to the control arm (n = 13). A difference in mean International Prostate Symptom Score at 12 months was found (adjusted mean difference of -1.81 points, 95% confidence interval -2.66 to -0.95 points), with a lower score in the intervention arm, indicating less severe symptoms. Secondary outcomes of patient-reported urinary symptoms, quality of life specific to lower urinary tract symptoms and perception of lower urinary tract symptoms all showed evidence of a difference between the arms favouring the intervention. No difference was seen between the arms in the proportion of urology referrals or adverse events. In qualitative interviews, participants welcomed the intervention, describing positive effects on their symptoms, as well as on their understanding of conservative care and their attitude towards the experience of lower urinary tract symptoms. The interviews highlighted that structured, in-depth self-management is insufficiently embedded within general practitioner consultations. From an NHS perspective, mean costs and quality-adjusted life-years were similar between trial arms. The intervention arm had slightly lower mean costs (adjusted mean difference of -£29.99, 95% confidence interval -£109.84 to £22.63) than the usual-care arm, and a small gain in quality-adjusted life-years (adjusted mean difference of 0.001, 95% confidence interval -0.011 to 0.014). Conclusions: The intervention showed a small, sustained benefit for men's lower urinary tract symptoms and quality of life across a range of outcome measures in a UK primary care setting. Qualitative data showed that men highly valued the intervention. Intervention costs were marginally lower than usual-care costs. Limitations of the study included that trial participants were unmasked, with limited diversity in ethnicity and deprivation level. Additional research is needed to assess the applicability of the intervention for a more ethnically diverse population.. Trial registration: This trial is registered as ISRCTN11669964. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/90/03) and is published in full in Health Technology Assessment; Vol. 28, No. 13. See the NIHR Funding and Awards website for further award information.

Urinary problems among men become more common with age. Nearly one-third of all men aged > 65 years experience some urinary symptoms, which can have a substantial effect on their daily lives. Symptoms include needing to pass urine more often, urgently or during the night, and difficulties in passing urine. Men are usually diagnosed and treated by their general practitioner, and should be offered advice on controlling their symptoms themselves (e.g. lifestyle changes and exercises) before trying tablets or surgery. However, it is not known how helpful such advice is, and how general practices can effectively provide it. Thirty general practices in the West of England and Wessex took part in the study. Practices were split into two groups, with each practice providing either the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions care package or the practice's usual care to all of its patients in the trial. The TReatIng Urinary symptoms in Men in Primary Healthcare using nonpharmacological and non-surgical interventions care package included a booklet of advice to help control urinary symptoms, with a nurse or healthcare assistant directing men to relevant sections according to their symptoms, and providing follow-up contacts. We mainly assessed the benefits of the TReatIng Urinary symptoms in Men in Primary Healthcare using nonpharmacological and non-surgical interventions care package, compared with usual care, by using a questionnaire on urinary symptoms completed by participants. A total of 1077 men with urinary symptoms that bothered them joined the study. The main result was that men reported greater improvement in urinary symptoms with the TRIUMPH care package than with usual care, 12 months after joining the study. We also found that men receiving the TRIUMPH care package had a slight improvement in quality of life and outlook on their urinary symptoms. There was no difference between the two groups in the number of patients referred to hospital for treatment, the type, number and severity of side effects or cost to the NHS. Overall, the TRIUMPH care package was more effective in treating men with urinary symptoms than usual care by their general practice.

Cost-effectiveness of a primary healthcare intervention to treat male lower urinary tract symptoms: the TRIUMPH cluster randomised controlled trial.

OBJECTIVES: To estimate the cost-effectiveness of a primary care intervention for male lower urinary tract symptoms (LUTS) compared with usual care. DESIGN: Economic evaluation alongside a cluster randomised controlled trial from a UK National Health Service (NHS) perspective with a 12-month time horizon. SETTING: Thirty NHS general practice sites in England. PARTICIPANTS: 1077 men aged 18 or older identified in primary care with bothersome LUTS. INTERVENTIONS: A standardised and manualised intervention for the treatment of bothersome LUTS was compared with usual care. The intervention group (n=524) received a standardised information booklet with guidance on conservative treatment for LUTS, urinary symptom assessment and follow-up contacts for 12 weeks. The usual care group (n=553) followed local guidelines between general practice sites. MEASURES: Resource use was obtained from electronic health records, trial staff and participants, and valued using UK reference costs. Quality-adjusted life-years (QALYs) were calculated from the EQ-5D-5L questionnaire. Adjusted mean differences in costs and QALYs and incremental net monetary benefit were estimated. RESULTS: 866 of 1077 (80.4%) participants had complete data and were included in the base-case analysis. Over the 12-month follow-up period, intervention and usual care arms had similar mean adjusted costs and QALYs. Mean differences were lower in the intervention arm for adjusted costs -£29.99 (95% CI -£109.84 to £22.63) while higher in the intervention arm for adjusted QALYs 0.001 (95% CI -0.011 to 0.014). The incremental net monetary benefit statistic was £48.01 (95% CI -£225.83 to £321.85) at the National Institute for Health and Care Excellence UK threshold of £20 000 per QALY. The cost-effectiveness acceptability curve showed a 63% probability of the intervention arm being cost-effective at this threshold. CONCLUSIONS: Costs and QALYs were similar between the two arms at 12 months follow-up. This indicates that the intervention can be implemented in general practice at neutral cost. TRIAL REGISTRATION NUMBER: ISRCTN11669964.

Development and first-in-human testing of FLUME urinary catheter with protected tip and relocated drainage holes.

Purpose: Evaluation of a catheter design which protects its tip with the retaining balloon when inflated, and has eyeholes at the base of the balloon to improve drainage. Materials and methods: Preclinical tests included assessment of retaining balloon performance, and microbiological blockage. Clinical testing evaluated short-term use and safety in hospital (stage 1) or the patient's usual residence (stage 2). Results: The retaining balloon supported static loads of 0.7kg, with reduced trauma when modelling forced evulsion. In vitro time to blockage with P. Mirabilis was significantly slower for FLUME compared with latex Foley catheters, but not the silicone Foley. Stage 1 testing (10 patients) confirmed balloon inflation, drainage, retention and removal, with no serious adverse events caused by catheterisation; one balloon failed to inflate, one patient could not be catheterised. Of five patients at stage 2, one had the catheter for 28 days without complication, one experienced spontaneous balloon deflation (14th day) and three needed early removal (blood clot, bypassing, difficulty connecting the drainage bag). Bacterial profiles of two FLUME catheters retained at least 2 weeks matched the Foley catheters. Acquired catheter colouration (two FLUME, one Foley) was not associated with biochemical change in the material. Conclusion: FLUME catheter performed well in preclinical blockage and balloon tests. Tests in 15 patients confirmed basic function and additional training was not needed for staff familiar with Foley catheterisation. Clinical issues commonly seen with catheters included failed catheterisation, clot blockage and bypassing. In addition, an unintended balloon deflation and a failure of bag connection occurred. Plain language summary: This article describes a new catheter design which aims to improve patient comfort and safety, and maximise bladder drainage, by protecting the bladder from the exposed catheter tip and by locating the drainage holes better. Various tests were done to check the catheter retaining balloon was safe and how well the catheter did when exposed to bacteria that could block it. The catheter was also used in people for the first time, to check it could be put in safely and functioned as intended. The results showed the FLUME catheter did well in the balloon and blockage tests. Tests in 15 patients confirmed basic function and showed placement was easy for staff familiar with conventional catheters. There were some clinical issues typical of urinary catheters and some possible improvements were identified.

Treatment of lower urinary tract symptoms in men in primary care using a conservative intervention: cluster randomised controlled trial.

OBJECTIVE: To determine whether a standardised and manualised care intervention in men in primary care could achieve superior improvement of lower urinary tract symptoms (LUTS) compared with usual care. DESIGN: Cluster randomised controlled trial. SETTING: 30 National Health Service general practice sites in England. PARTICIPANTS: Sites were randomised 1:1 to the intervention and control arms. 1077 men (≥18 years) with bothersome LUTS recruited between June 2018 and August 2019: 524 were assigned to the intervention arm (n=17 sites) and 553 were assigned to the usual care arm (n=13 sites). INTERVENTION: Standardised information booklet developed with patient and expert input, providing guidance on conservative and lifestyle interventions for LUTS in men. After assessment of urinary symptoms (manualised element), general practice nurses and healthcare assistants or research nurses directed participants to relevant sections of the manual and provided contact over 12 weeks to assist with adherence. MAIN OUTCOME MEASURES: The primary outcome was patient reported International Prostate Symptom Score (IPSS) measured 12 months after participants had consented to take part in the study. The target reduction of 2.0 points on which the study was powered reflects the minimal clinically important difference where baseline IPSS is <20. Secondary outcomes were patient reported quality of life, urinary symptoms and perception of LUTS, hospital referrals, and adverse events. The primary intention-to-treat analysis included 887 participants (82% of those recruited) and used a mixed effects multilevel linear regression model adjusted for site level variables used in the randomisation and baseline scores. RESULTS: Participants in the intervention arm had a lower mean IPSS at 12 months (adjusted mean difference -1.81 points, 95% confidence interval -2.66 to -0.95) indicating less severe urinary symptoms than those in the usual care arm. LUTS specific quality of life, incontinence, and perception of LUTS also improved more in the intervention arm than usual care arm at 12 months. The proportion of urology referrals (intervention 7.3%, usual care 7.9%) and adverse events (intervention seven events, usual care eight events) were comparable between the arms. CONCLUSIONS: A standardised and manualised intervention in primary care showed a sustained reduction in LUTS in men at 12 months. The mean difference of -1.81 points (95% confidence interval -0.95 to -2.66) on the IPSS was less than the predefined target reduction of 2.0 points. TRIAL REGISTRATION: ISRCTN Registry ISRCTN11669964.

Evaluation of the feasibility and acceptability of an integrative group psychological intervention for people with Multiple Sclerosis: A study protocol.

Multiple Sclerosis (MS) is characterised by significant symptom diversity and complexity. The unpredictability of the symptoms and the emotional and cognitive facets of the disease have a significant impact on the patients' quality of life, relationships and other significant areas of living. Psychological interventions have been found to have moderate effects on quality of life, depression, stress reduction, improvement of wellbeing, anxiety, fatigue, sleep disturbances and emotion regulation. Most interventions so far are based on generic models of therapy which cannot always cover the complexity and unpredictability of MS. The present research project follows from an exploratory mixed method study on the experience of psychological interventions and the impact on the management of MS. The results of that study generated themes that led to the development of an integrative group psychological intervention named MyMS-Ally. The current study aims to explore the feasibility and acceptability of MyMS-Ally intervention and obtain preliminary data on the effects on quality of life, emotion regulation, depression and anxiety through the application of a convergent mixed methods design. People with MS will be recruited at the Bristol and Avon Multiple Sclerosis centre, North Bristol NHS Trust. They will participate in MyMS-Ally group intervention for 8 weeks. Individual semi-structured interviews drawing on Interpretative Phenomenological methodology will be conducted before and after the intervention and at three months follow up. Participants will complete quantitative measures on quality of life, emotion regulation, depression and anxiety before and after the intervention and at one and three months follow up. The aim is to explore the relevance, sustainability and adherence to the intervention and study processes (feasibility) as well as the appropriateness of the intervention based on the emotional and cognitive responses, satisfaction and perceived effectiveness (acceptability). It is aspired that this patient-centred psychological intervention will address needs and preferences of people with MS. The results of the present study will provide data for further development of the intervention and will lead to a big scale evaluation study.

Hospital practitioner views on the benefits of continence education and best ways to provide training.

AIM: The aim of the study was to explore practitioners' experiences and perspectives on continence training, in order to understand its relevance to practice and how take-up of, and engagement with, such training may be improved. DESIGN: 27 qualitative interviews were conducted with nursing, medical and allied health practitioners in three hospitals. METHODS: We analysed data thematically, both manually and with the aid of NVivo software. The research adheres to the consolidated criteria for reporting qualitative research checklist. RESULTS: Practitioners asserted the likely benefits of evidence-based continence training, including more judicious use of products, reduction in associated infection, better patient skin care and more facilitative communication with patients. Practitioners also identified preferred methods of continence training, according to their role and workload. To ensure better take-up of, and engagement with, continence training, it must be authorized as essential and provided in ways that reflect professional preferences and pragmatic resource considerations.

Synthetic sling or artificial urinary sphincter for men with urodynamic stress incontinence after prostate surgery: the MASTER non-inferiority RCT.

BACKGROUND: Stress urinary incontinence is common in men after prostate surgery and can be difficult to improve. Implantation of an artificial urinary sphincter is the most common surgical procedure for persistent stress urinary incontinence, but it requires specialist surgical skills, and revisions may be necessary. In addition, the sphincter is relatively expensive and its operation requires adequate patient dexterity. New surgical approaches include the male synthetic sling, which is emerging as a possible alternative. However, robust comparable data, derived from randomised controlled trials, on the relative safety and efficacy of the male synthetic sling and the artificial urinary sphincter are lacking. OBJECTIVE: We aimed to compare the clinical effectiveness and cost-effectiveness of the male synthetic sling with those of the artificial urinary sphincter surgery in men with persistent stress urinary incontinence after prostate surgery. DESIGN: This was a multicentre, non-inferiority randomised controlled trial, with a parallel non-randomised cohort and embedded qualitative component. Randomised controlled trial allocation was carried out by remote web-based randomisation (1 : 1), minimised on previous prostate surgery (radical prostatectomy or transurethral resection of the prostate), radiotherapy (or not, in relation to prostate surgery) and centre. Surgeons and participants were not blind to the treatment received. Non-randomised cohort allocation was participant and/or surgeon preference. SETTING: The trial was set in 28 UK urological centres in the NHS. PARTICIPANTS: Participants were men with urodynamic stress incontinence after prostate surgery for whom surgery was deemed appropriate. Exclusion criteria included previous sling or artificial urinary sphincter surgery, unresolved bladder neck contracture or urethral stricture after prostate surgery, and an inability to give informed consent or complete trial documentation. INTERVENTIONS: We compared male synthetic sling with artificial urinary sphincter. MAIN OUTCOME MEASURES: The clinical primary outcome measure was men's reports of continence (assessed from questions 3 and 4 of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) at 12 months post randomisation (with a non-inferiority margin of 15%). The primary economic outcome was cost-effectiveness (assessed as the incremental cost per quality-adjusted life-year at 24 months post randomisation). RESULTS: In total, 380 men were included in the randomised controlled trial (n = 190 in each group), and 99 out of 100 men were included in the non-randomised cohort. In terms of continence, the male sling was non-inferior to the artificial urinary sphincter (intention-to-treat estimated absolute risk difference -0.034, 95% confidence interval -0.117 to 0.048; non-inferiority p = 0.003), indicating a lower success rate in those randomised to receive a sling, but with a confidence interval excluding the non-inferiority margin of -15%. In both groups, treatment resulted in a reduction in incontinence symptoms (as measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form). Between baseline and 12 months' follow-up, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score fell from 16.1 to 8.7 in the male sling group and from 16.4 to 7.5 in the artificial urinary sphincter group (mean difference for the time point at 12 months 1.30, 95% confidence interval 0.11 to 2.49; p = 0.032). The number of serious adverse events was small (male sling group, n = 8; artificial urinary sphincter group, n = 15; one man in the artificial urinary sphincter group experienced three serious adverse events). Quality-of-life scores improved and satisfaction was high in both groups. Secondary outcomes that showed statistically significant differences favoured the artificial urinary sphincter over the male sling. Outcomes of the non-randomised cohort were similar. The male sling cost less than the artificial sphincter but was associated with a smaller quality-adjusted life-year gain. The incremental cost-effectiveness ratio for male slings compared with an artificial urinary sphincter suggests that there is a cost saving of £425,870 for each quality-adjusted life-year lost. The probability that slings would be cost-effective at a £30,000 willingness-to-pay threshold for a quality-adjusted life-year was 99%. LIMITATIONS: Follow-up beyond 24 months is not available. More specific surgical/device-related pain outcomes were not included. CONCLUSIONS: Continence rates improved from baseline, with the male sling non-inferior to the artificial urinary sphincter. Symptoms and quality of life significantly improved in both groups. Men were generally satisfied with both procedures. Overall, secondary and post hoc analyses favoured the artificial urinary sphincter over the male sling. FUTURE WORK: Participant reports of any further surgery, satisfaction and quality of life at 5-year follow-up will inform longer-term outcomes. Administration of an additional pain questionnaire would provide further information on pain levels after both surgeries. TRIAL REGISTRATION: This trial is registered as ISRCTN49212975. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 36. See the NIHR Journals Library website for further project information.

Leakage of urine associated with physical exertion (e.g. sporting activities, sneezing or coughing) is common in men who have undergone prostate surgery, but it is difficult to improve. Many men still leak urine 12 months after their prostate surgery and may continue to wear protective pads or sheaths. The most common operation to improve incontinence is implantation of an artificial urinary sphincter. An artificial urinary sphincter is an inflatable cuff that is placed around the urethra, the tube that drains urine from the bladder. The cuff is inflated and compresses the urethra to prevent leaking. When the man needs to pass urine, he must deflate the cuff by squeezing a pump placed in his scrotum, which releases the compression on the urethra and allows the bladder to empty. Recently, a new device, the male sling (made from non-absorbable plastic mesh), has been developed. The sling, which is surgically inserted under the urethra, supports the bladder, but, in contrast to the artificial sphincter, it does not need to be deactivated by a pump and, therefore, the patient does not need to do anything to operate it. A sling is also easier for the surgeon to insert than a sphincter. However, in some men, the sling does not provide enough improvement in incontinence symptoms and another operation, to place an artificial urinary sphincter, is needed. The aim of this study was to determine if the male sling was as effective as the artificial urinary sphincter in treating men with bothersome incontinence after prostate surgery. The study took the form of a randomised controlled trial (the gold standard and most reliable way to compare treatments) in which men were randomised (allocated at random to one of two groups using a computer) to either a male sling or an artificial urinary sphincter operation. We asked men how they got on in the first 2 years after their operation. Regardless of which operation they had, incontinence and quality of life significantly improved and complications were rare. A small number of men did require another operation to improve their incontinence, and it was more likely that an artificial urinary sphincter was needed, rather than another sling operation, if a male sling was not successful. Satisfaction was high in both groups, but it was significantly higher in the artificial urinary sphincter group than in the male sling group. Those who received a male sling were less likely than those who received an artificial urinary sphincter to say that they would recommend their surgery to a friend.

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.

Qualitative Assessment of the Conservative Management of Nocturia with Standardised Written Materials for Lower Urinary Tract Symptoms in Men Treated in Primary Care.

BACKGROUND: Many men prefer conservative treatment of lower urinary tract symptoms (LUTS) but education and self-help guidance are limited in primary care. OBJECTIVE: To report qualitative interview findings for men reporting nocturia in a primary care setting for LUTS. DESIGN, SETTING, AND PARTICIPANTS: TRIUMPH (Treating Urinary Symptoms in Men in Primary Healthcare) is a multicentre cluster randomised trial of standardised manualised care (a booklet delivered by a health care professional) versus usual care for LUTS. The participants (524 in the intervention arm and 553 in the usual care arm) were men presenting for primary care for LUTS at 30 general practice (GP) sites in the UK. INTERVENTION: Delivery of a LUTS self-management booklet by health care staff in comparison to usual care for men with LUTS. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The qualitative component included 58 early-stage (0-3 mo after study enrolment) and 33 late-stage (3-9 mo later) interviews with participants to assess their experience of LUTS and conservative treatment in primary care. Purposive sampling was used to select participants for interview. RESULTS AND LIMITATIONS: Nocturia is a common driver for seeking health care and is perceived by men as relatively acceptable to discuss. Information and self-help guidance were largely absent from descriptions of GP consultations, other than reducing evening caffeine and fluid intake. The TRIUMPH LUTS intervention booklet offers explanations and self-management guidance. Men with long-term disruptive symptoms, a perception that the booklet content was novel or worthwhile, and a belief that self-management might help, were more receptive to the intervention. In follow-up, improvements in nocturia were related to successful implementation of several aspects of the guidance. Most men were willing to complete a bladder diary, but some found it inconvenient, especially men in employment. The characteristics of the trial population mean that the findings may not apply to all men. CONCLUSIONS: Reassuring men that nocturia is part of ageing without offering them information and support risks reinforcing the tendency to discount problematic LUTS. The trial booklet and the training of health care professionals support guidance on nocturia self-management, which is most effective for men receptive to this approach. However, the nature of the trial population means that the findings may not apply to all men. PATIENT SUMMARY: Men are more comfortable in discussing waking at night to urinate than talking about other urinary symptoms with their GP. This problem should lead to a detailed discussion of all urinary symptoms rather than being thought of as a sign of ageing. An information booklet and nurse consultation helped many men to improve this symptom.

Use of the International Consultation on Incontinence Questionnaires Bladder Diary in Men Seeking therapy for Lower Urinary Tract Symptoms.

BACKGROUND: Completion rates and correspondence to other measures need to be established for the International Consultation on Incontinence Questionnaire (ICIQ) bladder diary (ICIQ-BD) in the assessment of male lower urinary tract symptoms (LUTS). OBJECTIVE: To evaluate ICIQ-BD completion rates, frequency, volume, and sensation reporting for men. DESIGN, SETTING, AND PARTICIPANTS: Baseline data from the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) randomised controlled trial evaluating 820 men at 26 UK hospitals, looking at the ICIQ-BD, uroflowmetry, International Prostate Symptom Score, and ICIQ symptom score for male LUTS (ICIQ-MLUTS), were assessed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The ICIQ-BD, IPSS, ICIQ-MLUTS, and uroflowmetry data at baseline obtained from UPSTREAM were assessed. Correlations were analysed by Pearson's correlation coefficient, and comparison between groups were performed using paired or unpaired t tests or Tukey's test. All statistical tests were two sided and the strength of evidence was presented using p values. RESULTS AND LIMITATIONS: Of the participants, 25.0% (205/820) provided complete voiding and bedtime information for 3 d, 41.2% (338/820) omitted bedtime information, and the remainder omitted some or all voiding information. Median values (minimum - maximum) of 24-h, daytime, and night-time frequencies were 9.7 (3.3-24.0), 7.7 (3.3-22.7), and 1.7 (0.0-5.7), respectively. The mean voided volume per micturition for day and night times were 175.8 ± 74.2 and 264.4 ± 150.7 ml (p < 0.001), respectively. For fully completed diaries, day- and night-time frequency showed a weak-to-moderate correlation with symptom score questionnaires. More severe nocturia was generally reported in symptom scores than in the ICIQ-BD. In patients with high bother for increased daytime frequency (symptom), the mean daytime frequency (ICIQ-BD) was 9.6 ± 3.2 versus 7.6 ± 2.2 for low bother (p < 0.001). High bother for nocturia showed night-time frequency of 2.3 ± 1.2 versus 1.5 ± 1.1 for low bother (p < 0.001). For fully and partially completed diaries, ICIQ-BD sensation scores correlated weakly with symptom scores. Voided volumes from the bladder diary and uroflowmetry correlated weakly. CONCLUSIONS: Two-thirds of men (543/820) fully completed voiding information in the ICIQ-BD, but many omitted bedtime information, limiting the ability to quantify nocturia and diagnose nocturnal polyuria. PATIENT SUMMARY: Most men with urinary symptoms complete a bladder diary fully but may fail to indicate bedtimes. Extra information from a diary helps support symptom questionnaires to explain a patient's urinary habits.

Association of Sleep Disorders with Nocturia: A Systematic Review and Nominal Group Technique Consensus on Primary Care Assessment and Treatment.

CONTEXT: Sleep disorders affect responsiveness to sensory information and can cause nocturnal polyuria and reduced sleep depth; hence, these are potentially influential in understanding the mechanism of nocturia. OBJECTIVE: To report the systematic review (SR) and expert consensus for primary care management of nocturia in sleep disorders. EVIDENCE ACQUISITION: Four databases were searched from January to April 2020. A total of 1658 titles and abstracts were screened, and 23 studies potentially applicable were included for full-text screening. The nominal group technique (NGT) was used to derive a consensus on recommendations for management using an expert panel with public involvement. EVIDENCE SYNTHESIS: Thirteen studies met the SR inclusion criteria, all of which studied obstructive sleep apnoea (OSA), with ten evaluating the effect of continuous positive airway pressure. The NGT consensus discussed the assessment of OSA with other key sleep disorders, notably insomnia, restless legs syndrome/periodic limb movements of sleep, and parasomnias, including non-rapid eye movement (non-REM) parasomnias and REM sleep behaviour disorder (RBD). The NGT considered that the use of screening questions to reach a clinical diagnosis is a sufficient basis for offering conservative therapy within primary care. Reasons for referral to a sleep clinic are suspected sleep disorder with substantially impaired daytime function despite conservative treatment. Suspected RBD should be referred, and if confirmed, neurology opinion is indicated. Referrals should follow local guidelines. Persisting nocturia is not currently considered an indication for referral to a sleep clinic. CONCLUSIONS: Sleep disorders are potentially highly influential in nocturia, but are often overlooked. PATIENT SUMMARY: People with sleep disorders can experience nocturia due to easy waking or increased bladder filling. We looked at published research, and information was limited to one form of sleep disturbance-obstructive sleep apnoea. We assembled a group of experts, to develop practical approaches for assessing and treating nocturia in the potentially relevant sleep disorders.

Assessment and Treatment of Nocturia in Neurological Disease in a Primary Care Setting: Systematic Review and Nominal Group Technique Consensus.

CONTEXT: Neurological disease can affect the rate of urine production and bladder storage function, increasing nocturia severity, with additional risks if mobility or cognition is impaired. OBJECTIVE: To conduct a systematic review (SR) of nocturia in neurological diseases and achieve expert consensus for management in clinics without neurologist input. EVIDENCE ACQUISITION: Four databases were searched from January 2000 to April 2020. A total of 6262 titles and abstracts were screened and 43 studies were included for full-text screening. Eleven of these met the inclusion criteria and two studies were identified through other sources. The nominal group technique (NGT) was used to develop consensus in panel comprising experts and public representation. EVIDENCE SYNTHESIS: Thirteen studies (seven in Parkinson's disease, five in multiple sclerosis) were included, all undertaken in secondary care. Neurological disease severity was incompletely described, and nocturia severity was generally measured subjectively. NGT consensus supported basic neurological assessment, and the use of bladder diaries where neurological impairment permits. Treatments include pelvic-floor muscle training, review of medications, risk mitigation, improving bowel function, therapy for overactive bladder syndrome (if urgency is reported in association with nocturia episodes), treatment of postvoid residual and desmopressin according to licence. Measures to improve mobility and mitigate risk when using the toilet overnight should be considered. Multifactorial issues such as obstructive sleep apnoea and hypoventilation must be considered. CONCLUSIONS: Nocturia in neurological disease is complex and lacks a robust evidence base, with very little research done in the primary care context. Guidance should be pragmatic, with reduction of risk a key requirement, until a multidisciplinary evidence base can be developed. PATIENT SUMMARY: People with a neurological disease can suffer severe sleep disturbance because of the need to pass urine several times overnight (called nocturia). We looked at published research and found very little information to help general practitioners in managing this condition. We assembled a group of experts to develop practical approaches for assessing and treating nocturia in neurological disease.

Implications of Cardiovascular Disease for Assessment and Treatment of Nocturia in Primary Care: Systematic Review and Nominal Group Technique Consensus.

CONTEXT: Heart conditions affect salt and water homeostasis as a consequence of the underlying condition, compensatory processes, and therapy, and can result in nocturnal polyuria. These processes need to be identified as part of a full evaluation of nocturia. OBJECTIVE: To conduct a systematic review of nocturia in cardiovascular disease and achieve expert consensus for primary care management. Primary care was defined as a health care setting in which the expertise did not include specialist cardiology. EVIDENCE ACQUISITION: Four databases were searched from January 2000 to April 2020. A total of 3524 titles and abstracts were screened and 27 studies underwent full-text screening. Of these, eight studies were included in the analysis. The nominal group technique (NGT) was used to achieve consensus among an expert panel incorporating public involvement. EVIDENCE SYNTHESIS: Most studies focused on nocturia related to blood pressure (BP), while one investigated leg oedema. Hypertension, particularly overnight blood pressure above normal, corresponds with higher risk of nocturia. NGT identified fluid and salt overload, nondipping hypertension, and some therapeutic interventions as key nocturia contributors. History taking and examination should identify raised jugular venous pressure/ankle swelling, with relevant investigations including measurement of BP, resting electrocardiogram, and B-type natriuretic peptide. Treatment recommends reducing salt (including substitutes), alcohol and caffeine. Heart failure is managed according to local guidance and controlling fluid intake to 1-2 l daily. If there is no fluid retention, reduce or discontinue diuretics or calcium channel blockers and follow up to reassess the condition. The target clinic blood pressure is 140/90 mm Hg. CONCLUSIONS: Cardiovascular disease and its treatment are influential for understanding nocturia. Management aims to identify and treat heart failure and/or hypertension. PATIENT SUMMARY: People with cardiovascular disease can suffer severe sleep disturbance because of a need to pass urine at night due to increased overnight blood pressure or heart failure. Following a detailed evaluation of the published research, a group of experts recommended practical approaches for assessing and treating these issues.

Nocturia and Chronic Kidney Disease: Systematic Review and Nominal Group Technique Consensus on Primary Care Assessment and Treatment.

CONTEXT: Reduced renal function impairs salt and water homeostasis, which can drive nocturnal or 24-h polyuria. Nocturia can arise early in chronic kidney disease (CKD). Evidence-based recommendations can facilitate management outside nephrology clinics. OBJECTIVE: To conduct a systematic review (SR) of nocturia in CKD and achieve expert consensus for management in primary care and in specialist clinics outside nephrology. EVIDENCE ACQUISITION: Four databases were searched from January 2000 to April 2020. A total of 4011 titles and abstracts were screened, and 108 studies underwent full-text screening. Seven studies met the inclusion criteria and two were identified through other sources. Consensus was achieved among an expert panel with public involvement using the nominal group technique (NGT). EVIDENCE SYNTHESIS: Several plausible mechanisms contribute to nocturnal or 24-h polyuria in CKD, but there is little evidence on interventions to improve nocturia. NGT assessment recommendations for nocturia (at least two voids per night) in patients with CKD or at risk of CKD being assessed in a non-nephrology setting are: history (thirst, fluid intake), medication review (diuretics, lithium, calcium channel antagonists, nonsteroidal anti-inflammatory medications), examination (oedematous state, blood pressure), urinalysis (haematuria and albumin/creatinine ratio), blood tests (blood urea, serum creatinine and electrolytes, estimated glomerular filtration rate), and a bladder diary. Renal ultrasound should follow local CKD guidelines. Treatment options include optimising blood pressure control, dietary adjustment to reduce salt intake, fluid advice, and a medication review. Referral to specialist nephrology services should follow local guidelines. CONCLUSIONS: CKD should be considered when evaluating patients with nocturia. The aim of assessment is to identify mechanisms and instigate therapy, but the latter may be more applicable to reducing wider morbidity associated with CKD than nocturia itself. PATIENT SUMMARY: People with kidney disease can suffer severe sleep disturbance because of a need to pass urine overnight. We looked at published research and found some useful information about the underlying mechanisms. A group of experts was able to develop practical approaches for assessing and treating this condition.

Assessment and Treatment of Nocturia in Endocrine Disease in a Primary Care Setting: Systematic Review and Nominal Group Technique Consensus.

CONTEXT: Salt and water homeostasis is regulated hormonally, so polyuria can result from endocrine disease directly or via secondary effects. These mechanisms are not consistently considered in primary care management of nocturia. OBJECTIVE: To conduct a systematic review (SR) of nocturia in endocrine disease and reach expert consensus for primary care management. EVIDENCE ACQUISITION: Four databases were searched from January 2000 to April 2020. A total of 4382 titles and abstracts were screened, 36 studies underwent full-text screening, and 14 studies were included in the analysis. Expert and public consensus was achieved using the nominal group technique (NGT). EVIDENCE SYNTHESIS: Twelve studies focused on mechanisms of nocturia, while two evaluated treatment options; none of the studies took place in a primary care setting. NGT consensus identified key clinical evaluation themes, including the presence of thirst, a medical background of diabetes mellitus or insipidus, thyroid disease, oestrogen status, medications (fluid loss or xerostomia), and general examination including body mass index. Proposed investigations include a bladder diary, renal and thyroid function, calcium, and glycated haemoglobin. Morning urine osmolarity should be examined in the context of polyuria of >2.5 l/24 h persisting despite fluid advice, with urine concentration >600 mOsm/l after fluid restriction excluding diabetes insipidus. Treatment should involve education, including adjustment of lifestyle and medication where possible. Any underlying endocrine disorder should be managed according to local guidance. Referral to endocrinology is needed if there is hyperthyroidism, hyperparathyroidism, or morning urine osmolarity <600 mOsm/l after overnight fluid avoidance. CONCLUSIONS: Endocrine disease can result in nocturia via varied salt and water regulation pathways. The aim of management is to identify and treat causative factors, but secondary effects can restrict improvements in nocturia. PATIENT SUMMARY: People with altered hormone function can suffer from severe sleep disturbance because of a need to pass urine caused by problems in controlling water and salt levels. An expert panel recommended the best ways to assess and treat these problems on the basis of the rather small amount of up-to-date published research available.

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.

'We tend to get pad happy': a qualitative study of health practitioners' perspectives on the quality of continence care for older people in hospital.

BACKGROUND: Bladder and bowel control difficulties affect 20% and 10% of the UK population, respectively, touch all age groups and are particularly prevalent in the older (65+ years) population. However, the quality of continence care is often poor, compromising patient health and well-being, increasing the risk of infection, and is a predisposing factor to nursing and residential home placement. OBJECTIVE: To identify factors that help or hinder good continence care for patients aged 65 years and over in hospital medical ward settings. Medical care, not surgical, was our exclusive focus. METHODS: We conducted 27 qualitative interviews with nursing, medical and allied health practitioners in three hospitals. We used a purposive sample and analysed data thematically, both manually and with the aid of NVivo software. RESULTS: Interviews revealed perspectives on practice promoting or inhibiting good quality continence care, as well as suggestions for improvements. Good continence care was said to be advanced through person-centred care, robust assessment and monitoring, and a proactive approach to encouraging patient independence. Barriers to quality care centred on lack of oversight, automatic use of incontinence products and staffing pressures. Suggested improvements centred on participatory care, open communication and care planning with a higher bladder and bowel health profile. In order to drive such improvements, hospital-based practitioners indicate a need and desire for regular continence care training. CONCLUSIONS: Findings help explain the persistence of barriers to providing good quality care for patients aged 65 years and over with incontinence. Resolute continence promotion, in hospitals and throughout the National Health Service, would reduce reliance on products and the accompanying risks of patient dependency and catheter-associated gram-negative bacteraemia. Robust assessment and care planning, open communication and regular continence care training would assist such promotion and also help mitigate resource limitations by developing safer, time-efficient continence care.

Outcomes of a Noninferiority Randomised Controlled Trial of Surgery for Men with Urodynamic Stress Incontinence After Prostate Surgery (MASTER).

BACKGROUND: Stress urinary incontinence (SUI) is common after radical prostatectomy and likely to persist despite conservative treatment. The sling is an emerging operation for persistent SUI, but randomised controlled trial (RCT) comparison with the established artificial urinary sphincter (AUS) is lacking. OBJECTIVE: To compare the outcomes of surgery in men with bothersome urodynamic SUI after prostate surgery. DESIGN, SETTING, AND PARTICIPANTS: A noninferiority RCT was conducted among men with bothersome urodynamic SUI from 27 UK centres. Blinding was not possible due the surgeries. INTERVENTION: Participants were randomly assigned (1:1) to the male transobturator sling (n = 190) or the AUS (n = 190) group. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was patient-reported SUI 12 mo after randomisation, collected from postal questionnaire using a composite outcome from two items in validated International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire (ICIQ-UI SF). Noninferiority margin was 15%, thought to be of acceptable lower effectiveness, in return for reduced adverse events (AEs) and easier operation, for the sling. Secondary outcomes were operative and postoperative details, patient-reported measures, and AEs, up to 12 mo after surgery. RESULTS AND LIMITATIONS: A total of 380 participants were included. At 12 mo after randomisation, incontinence rates were 134/154 (87.0%) for male sling versus 133/158 (84.2%) for AUS (difference 3.6% [95% confidence interval {CI} -11.6 to 4.6], pNI = 0.003), showing noninferiority. Incontinence symptoms (ICIQ-UI SF) reduced from scores of 16.1 and 16.4 at baseline to 8.7 and 7.5 for male sling and AUS, respectively (mean difference 1.4 [95% CI 0.2-2.6], p =  0.02). Serious AEs (SAEs) were few: n = 6 and n = 13 for male sling and AUS (one man had three SAEs), respectively. Quality of life scores improved, and satisfaction was high in both groups. All other secondary outcomes that show statistically significant differences favour the AUS. CONCLUSIONS: Using a strict definition, urinary incontinence rates remained high, with no evidence of difference between male sling and AUS. Symptoms and quality of life improved significantly in both groups, and men were generally satisfied with both procedures. Overall, secondary and post hoc analyses were in favour of AUS. PATIENT SUMMARY: Urinary incontinence after prostatectomy has considerable effect on men's quality of life. MASTER shows that if surgery is needed, both surgical options result in fewer symptoms and high satisfaction, despite most men not being completely dry. However, most other results indicate that men having an artificial urinary sphincter have better outcomes than those who have a sling.