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.

Long-term catheter management in the community: a population-based analysis of user characteristics, service utilisation and costs in England.

BACKGROUND: Long-term urinary catheters are problematic and burdensome for patients, carers and health services. Nursing practice to improve the management of long-term urinary catheters has been held back by a lack of evidence to support policy and practice. Little is known about who uses a catheter long term and the resources and costs needed for their management. Understanding these costs will help to target innovations to improve care. There have been no substantial innovations to urinary catheters or their management recently and no publications to characterise users and costs. AIM: To describe long-term catheter users and explore catheter-related service use and costs in England. METHODS: Descriptive information on the characteristics of catheter users and their use of services was obtained from: General Practice records (n = 607), district nursing records (n = 303), questionnaires to patients (n = 333) and triangulated, 2009-2012. Annual service costs (British pounds 2011) were computed. FINDINGS: Most catheter users (59.6%) were men, nearly three-quarters (71.2%) were over 70 years and 60.8% used a urethral catheter. Women tended to be younger than men and more likely to use a suprapubic catheter. The services used most frequently over 12 months were general practitioner (by 63.1%) and out of hours services (43.0%); 15.5% accessed Accident and Emergency services for urgent catheter-related care. Hospital use accounted for nearly half (48.9%) of total health service costs (mainly due to inpatient stays by 13.6% of participants); catheter supplies/medications were next most costly (25.7%). Half of all costs were accounted for by 14.2% of users. The median annual cost of services used was £6.38, IQR: £344-£1324; district nursing services added approximately a further £200 per annum. CONCLUSIONS: Finding better ways to reduce catheter problems (e.g. blockage, infection) that cause unplanned visits, urgent or hospital care should be a priority to improve quality of life for long-term catheter users and reduce health service expenditure.

Technology for managing incontinence: What are the research priorities?

Incontinence and toileting difficulties can often be successfully addressed by treating their underlying causes. However, (complete) cure is not always possible and continence products to prevent or contain unresolved leakage or to facilitate toileting are in widespread use. Many people use them successfully but identifying the product(s) most likely to meet individual needs can be challenging and the recently published Seventh International Consultation on Incontinence includes a chapter which draws on the literature to provide evidence-based recommendations to help clinicians and product users to select appropriate products. This paper is based on the same evidence, but reviewed from the different perspective of those keen to identify unmet needs and develop improved products. For each of the main continence product categories it (i) outlines the design approach and key features of what is currently available; (ii) provides a generic functional design specification; (iii) reviews how well existing products meet the requirements of their main user groups; and (iv) suggests priorities for the attention of product designers. It also flags some core scientific problems which - if successfully addressed - would likely yield benefits in multiple incontinence product contexts.

Healthcare professionals' experiences and views of providing continence support and advice to people living at home with dementia: "That's a carer's job".

BACKGROUND: People living with dementia at home and their family carers often feel unsupported by healthcare professionals in managing continence problems. In turn, primary and community-based healthcare professionals have reported lacking specific knowledge on dementia-continence. This study aimed to understand more about healthcare professionals' experiences and views of supporting people living with dementia experiencing continence problems, as part of developing acceptable resources. Having a nuanced understanding of unmet need would facilitate the design of engaging resources that enable healthcare professionals to provide more effective continence support to people living with dementia at home. METHODS: Semi-structured interviews were conducted with a range of healthcare professionals (n = 31) working in primary and community care in the South of England in 2023. Transcribed interviews were uploaded to NVivo 12, then analysed inductively and deductively using a thematic framework. RESULTS: Continence-related conversations were avoided by many healthcare professionals due to lack of dementia-continence specific knowledge. Many considered that continence problems of people living with dementia were largely outside their remit once a physical cause had been ruled out. This contributed to a lack of priority and proactivity in raising the subject of continence in their consultations. Challenges to providing support included limited consultation time and lack of access to specialist services with availability to support individuals. CONCLUSION: There is substantial scope to support primary and community-based healthcare professionals in their provision of continence-related support and advice to people living at home with dementia. This includes addressing knowledge deficits, enhancing confidence and instilling a sense of accomplishment.

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.

Supported Intervention Versus Intervention Alone for Management of Fecal Incontinence in Patients With Inflammatory Bowel Disease: A Multicenter Mixed-Methods Randomized Controlled Trial.

PURPOSE: The aims of this study were to test a noninvasive self-management intervention supported by specialist nurses versus intervention alone in patients with inflammatory bowel disease (IBD) experiencing fecal incontinence and to conduct a qualitative evaluation of the trial. DESIGN: Multicenter, parallel-group, open-label, mixed-methods randomized controlled trial (RCT). SUBJECTS AND SETTING: The sample comprised patients from a preceding case-finding study who reported fecal incontinence and met study requirements; the RCT was delivered via IBD outpatient clinics in 6 hospitals (5 in major UK cities, 1 rural) between September 2015 and August 2017. Sixteen participants and 11 staff members were interviewed for qualitative evaluation. METHODS: Adults with IBD completed the study activities over a 3-month period following randomization. Each participant received either four 30-minute structured sessions with an IBD clinical nurse specialist and a self-management booklet or the booklet alone. Low retention numbers precluded statistical analysis; individual face-to-face or telephone interviews, recorded digitally and transcribed professionally, were conducted to evaluate the RCT. Transcripts were analyzed thematically using an inductive method. RESULTS: Sixty-seven participants (36%) of the targeted 186 participants were recruited. The groups comprised 32 participants (17% of targeted participants) allocated to the nurse + booklet intervention and 35 (18.8% of targeted participants) allocated to the booklet alone. Less than one-third (n = 21, 31.3%) completed the study. Given the low recruitment and high attrition, statistical analysis of quantitative data was considered futile. Participant interviews were conducted concerning study participation and 4 themes emerged that described experiences of patients and staff. These data provided insights into reasons for low recruitment and high attrition, as well as challenges of delivering resource-heavy studies in busy health service environments. CONCLUSIONS: Alternative approaches to trials of nurse-led interventions in hospital settings are needed as many interfering factors may prevent successful completion.

Using consensus methods to prioritize modifiable risk factors for development of manifestations of frailty in hospitalized older adults.

AIM: The aim of the study was to reach consensus on modifiable risk factors for a novel system of care to address Manifestations of Frailty in hospitalized older adults. DESIGN: Consensus study. METHOD: A modified nominal group technique, incorporating expert group face-to-face interaction, review of existing evidence and pre/post-meeting questionnaire completion was undertaken November 2019-February 2020. RESULTS: Seventy-one risk factors, within seven risk factor domains (pain, medication, fluid and nutrition intake, mobility, elimination, infection, additional patient factors) were considered. It was agreed that 44 risk factors incorporating patient, organizational and environmental risk factors were modifiable and should be included in a novel system of care.

Experiences and impact of living with incontinence associated stigma: A protocol for a systematic review and narrative synthesis of qualitative studies.

INTRODUCTION: Incontinence is global health and social issue, with urinary incontinence alone affecting over 400 million people. Incontinence can lead to physical harms such as skin damage, but it also commonly causes social and psychological harms, including those associated with stigma. For many people, treatment to cure incontinence does not work or is not suitable and they live with the long-term consequences of incontinence. At the moment, no stigma reduction interventions (increasingly used with other conditions such as mental health problems and HIV) have been developed for people living with incontinence. As a starting point for developing such an intervention, this review will address the questions 1) What are the incontinence (urinary or faecal) associated experiences of stigma of people living with incontinence? 2) What is the impact of incontinence associated stigma on their lives? METHODS: The reviewers will search Embase, Medline, PsychINFO and the Cumulative Index to Nursing and Allied Health Literature using controlled vocabulary and relevant search terms. Articles assessed to meet inclusion criteria will be included. Once duplicates have been removed, titles and abstracts will be screened and full texts of selected research articles will be reviewed. An adapted Joanna Briggs Institute Data Extraction Form will be used to collect the data and quality will be assessed using the Joanna Briggs Institute checklist for qualitative research appraisal tool. A framework approach (using the Revised Framework for Understanding Non-communicable Disease Related Stigma) will be used to organise, integrate, interpret and summarise findings from included articles. The review will be reported in accordance with the Enhancing Transparency in reporting the synthesis of qualitative research statement. Prospero registration number CRD42021259065. DISCUSSION: The systematic review described in this protocol will provide the first in-depth, comprehensive understanding of people's experiences of the stigma associated with incontinence and the impact that it has on their lives. It will identify broader influences of contextual variables such as age, sex, cause and type of incontinence, socio-economic culture and geographical location. The review aims to provide insights to support the development of incontinence associated stigma reduction interventions.

A qualitative study of continence service provision for people living with dementia at home in the UK: Still inadequate?

INTRODUCTION: Incontinence is a major problem for people with dementia (PWD) and their family/friend caregivers, often causing substantial harm, including residential care admission. The incontinence needs of PWD are complex and different from those of people without dementia. The aim of this study was to investigate carer and nurse perceptions of continence service provision and potential improvements. METHODS: A secondary analysis of qualitative data was undertaken. Semi-structured interviews (n = 45) were undertaken with PWD, family caregivers and healthcare professionals (continence or dementia nurses) in the UK. PWD and caregivers were recruited via www.joindementiaresearch.nihr.ac.uk and via dementia/carer groups. Nurses were recruited via their employers. Framework analysis was used. The COREQ Research guideline statement assists reporting. RESULTS: Four themes were found. Firstly, there was a lack of awareness of the service and waiting time. Many caregivers were unaware of continence services and dementia nurses often viewed it as a pad provision service. Caregivers reported long waits not meeting their urgent needs. Secondly, product provision was often inadequate. Most caregivers self-purchased all or many products and substantial variation in product provision was found. The number of products provided was often inadequate. Thirdly, a sense that "nothing can be done" was observed by some nurses and caregivers. Caregivers believed that, if nothing else, care information should be provided. Finally, suggestions for improvements were made, including proactive service signposting, joint clinics with dementia services, improved information before crisis point, dementia training for continence nurses and improved product provision. CONCLUSION: Continence service inadequacies for PWD and caregivers have been reported for many years. This study demonstrates service provision remains unsatisfactory in the UK. Stakeholders propose a range of service improvements. It highlights that listening to the voices of PWD, caregivers and nurses is crucial for services seeking to improve continence services for PWD living at home.

A qualitative study and preliminary model of living with dementia and incontinence at home: beyond containment.

BACKGROUND: most people living with dementia (PLWD) will develop incontinence problems with associated harmful consequences. Well-contained incontinence is often the main treatment goal. It would therefore be expected that poorly contained incontinence would have a negative impact. AIM: to investigate differences in how well-contained or poorly contained incontinence impacts on the experience of living with incontinence for PLWD at home and their carers. DESIGN: secondary analysis of a qualitative study. METHODS: semi-structured interviews were undertaken with PLWD, carers and healthcare professionals (continence or dementia nurses). PLWD and carers were recruited via www.joindementiaresearch.nihr.ac.uk and via dementia/carer groups. Nurses were recruited via their employers. Interviews were recorded and transcribed verbatim. Framework analysis was used. RESULTS: forty-five people (twenty-six carers, two PLWD, nine continence nurses and eight dementia nurses) participated. Despite poorly contained incontinence, some PLWD/carer dyads appeared relatively unaffected by incontinence. Conversely, one or both members of some dyads who achieved good containment found incontinence care highly challenging. Four themes were identified, together forming a preliminary model of incontinence containment and impact, as follows. CONCLUSION: reliable containment is an important goal for PLWD living at home and their carers, but it is not the only goal. Other factors, such as behaviours that challenge or carer coping strategies, can mean that even well-contained incontinence can have a negative impact. This paper proposes a preliminary model for evaluation.

Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions.

BACKGROUND: Intermittent catheterisation (IC) is a commonly recommended procedure for people with incomplete bladder emptying. Frequent complications are urinary tract infection (UTI), urethral trauma and discomfort during catheter use. Despite the many designs of intermittent catheter, including different lengths, materials and coatings, it is unclear which catheter techniques, strategies or designs affect the incidence of UTI and other complications, measures of satisfaction/quality of life and cost-effectiveness. This is an update of a Cochrane Review first published in 2007.  OBJECTIVES: To assess the clinical and cost-effectiveness of different catheterisation techniques, strategies and catheter designs, and their impact, on UTI and other complications, and measures of satisfaction/quality of life among adults and children whose long-term bladder condition is managed by intermittent catheterisation. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 12 April 2021), the reference lists of relevant articles and conference proceedings, and we attempted to contact other investigators for unpublished data or for clarification. SELECTION CRITERIA: Randomised controlled trials (RCTs) or randomised cross-over trials comparing at least two different catheterisation techniques, strategies or catheter designs. DATA COLLECTION AND ANALYSIS: As per standard Cochrane methodological procedures, two review authors independently extracted data, assessed risk of bias and assessed the certainty of evidence using GRADE. Outcomes included the number of people with symptomatic urinary tract infections, complications such as urethral trauma/bleeding, comfort and ease of use of catheters, participant satisfaction and preference, quality of life measures and economic outcomes. MAIN RESULTS: We included 23 trials (1339 randomised participants), including twelve RCTs and eleven cross-over trials. Most were small (fewer than 60 participants completed), although three trials had more than 100 participants. Length of follow-up ranged from one month to 12 months and there was considerable variation in definitions of UTI. Most of the data from cross-over trials were not presented in a useable form for this review. Risk of bias was unclear in many domains due to insufficient information in the trial reports and several trials were judged to have a high risk of performance bias due to lack of blinding and a high risk of attrition bias. The certainty of evidence was downgraded for risk of bias, and imprecision due to low numbers of participants.    Aseptic versus clean technique We are uncertain if there is any difference between aseptic and clean techniques in the risk of symptomatic UTI because the evidence is low-certainty and the 95% confidence interval (CI) is consistent with possible benefit and possible harm (RR 1.20 95% CI 0.54 to 2.66; one study; 36 participants). We identified no data relating to the risk of adverse events comparing aseptic and clean techniques or participant satisfaction or preference.  Single-use (sterile) catheter versus multiple-use (clean) We are uncertain if there is any difference between single-use and multiple-use catheters in terms of the risk of symptomatic UTI because the certainty of evidence is low and the 95% CI is consistent with possible benefit and possible harm (RR 0.98, 95% CI 0.55, 1.74; two studies; 97 participants). One study comparing single-use catheters to multiple-use catheters reported zero adverse events in either group; no other adverse event data were reported for this comparison. We identified no data for participant satisfaction or preference. Hydrophilic-coated catheters versus uncoated catheters We are uncertain if there is any difference between hydrophilic and uncoated catheters in terms of the number of people with symptomatic UTI because the certainty of evidence is low and the 95% CI is consistent with possible benefit and possible harm (RR 0.89, 95% CI 0.69 to 1.14; two studies; 98 participants). Uncoated catheters probably slightly reduce the risk of urethral trauma and bleeding compared to hydrophilic-coated catheters (RR 1.37, 95% CI 1.01 to 1.87; moderate-certainty evidence). The evidence is uncertain if hydrophilic-coated catheters compared with uncoated catheters has any effect on participant satisfaction measured on a 0-10 scale (MD 0.7 higher, 95% CI 0.19 to 1.21; very low-certainty evidence; one study; 114 participants). Due to the paucity of data, we could not assess the certainty of evidence relating to participant preference (one cross-over trial of 29 participants reported greater preference for a hydrophilic-coated catheter (19/29) compared to an uncoated catheter (10/29)).  AUTHORS' CONCLUSIONS: Despite a total of 23 trials, the paucity of useable data and uncertainty of the evidence means that it remains unclear whether the incidence of UTI or other complications is affected by use of aseptic or clean technique, single (sterile) or multiple-use (clean) catheters, coated or uncoated catheters or different catheter lengths. The current research evidence is uncertain and design and reporting issues are significant. More well-designed trials are needed. Such trials should include analysis of cost-effectiveness because there are likely to be substantial differences associated with the use of different catheterisation techniques and strategies, and catheter designs.

Biofilm Development on Urinary Catheters Promotes the Appearance of Viable but Nonculturable Bacteria.

Catheter-associated urinary tract infections have serious consequences, for both patients and health care resources. Much work has been carried out to develop an antimicrobial catheter. Although such developments have shown promise under laboratory conditions, none have demonstrated a clear advantage in clinical trials. Using a range of microbiological and advanced microscopy techniques, a detailed laboratory study comparing biofilm development on silicone, hydrogel latex, and silver alloy-coated hydrogel latex catheters was carried out. Biofilm development by Escherichia coli, Pseudomonas aeruginosa, and Proteus mirabilis on three commercially available catheters was tracked over time. Samples were examined with episcopic differential interference contrast (EDIC) microscopy, culture analysis, and staining techniques to quantify viable but nonculturable (VBNC) bacteria. Both qualitative and quantitative assessments found biofilms to develop rapidly on all three materials. EDIC microscopy revealed the rough surface topography of the materials. Differences between culture counts and quantification of total and dead cells demonstrated the presence of VBNC populations, where bacteria retain viability but are not metabolically active. The use of nonculture-based techniques showed the development of widespread VBNC populations. These VBNC populations were more evident on silver alloy-coated hydrogel latex catheters, indicating a bacteriostatic effect at best. The laboratory tests reported here, which detect VBNC bacteria, allow more rigorous assessment of antimicrobial catheters, explaining why there is often minimal benefit to patients.IMPORTANCE Several antimicrobial urinary catheter materials have been developed, but, although laboratory studies may show a benefit, none have significantly improved clinical outcomes. The use of poorly designed laboratory testing and lack of consideration of the impact of VBNC populations may be responsible. While the presence of VBNC populations is becoming more widely reported, there remains a lack of understanding of the clinical impact or influence of exposure to antimicrobial products. This is the first study to investigate the impact of antimicrobial surface materials and the appearance of VBNC populations. This demonstrates how improved testing is needed before clinical trials are initiated.

Problems faced by people living at home with dementia and incontinence: causes, consequences and potential solutions.

BACKGROUND: many people living at home with dementia (PLWD) also have poorly managed toilet-use or incontinence problems with damaging consequences for both people with dementia, unpaid carers and healthcare professionals (HCPs). Currently, there are no theoretically or empirically based interventions to help. The underlying causes and subsequent consequences of these problems need to be fully understood in order to support the development of interventions that have the potential to decrease the impact of these problems on people's lives. AIM: to establish the range of causes, consequences and potential solutions of toilet-use and incontinence problems for PLWD and their carers. METHOD: a qualitative design was used. Semi-structured interviews were undertaken with PLWD, carers and HCPs (continence or dementia nurses). PLWD and carers were recruited via www.joindementiaresearch.nihr.ac.uk and via dementia/carer groups. Nurses were recruited via their employers. Interviews were digitally recorded and transcribed verbatim. Framework analysis was used to interpret the data to address the goal of the research. RESULTS: in total, 45 people (26 unpaid carers, 2 people with dementia, 9 continence and 8 dementia HCPs) took part. The causes of toilet-use and incontinence problems were reported to be multi-faceted and complex including those related to dementia (e.g. lack of insight into toileting needs or how to use the toilet), those which are physical (e.g. existing bladder or bowel issues or poor mobility), psychosocial (e.g. inability to ask for help for incontinence) or societal (e.g. fear of stigma), or related to care systems (e.g. lack of expert knowledge) or products (e.g. poor fit or confusing for users). Consequences included harms to physical and mental health, social isolation, increased carer workload and care system resource implications. CONCLUSION: this study provides the first detailed characterisation of the causes and consequences of and potential solutions for incontinence problems for PLWD at home and their carers. Multifaceted and complex problems were identified, layering dementia, physical, psychosocial, societal and care system factors and highlighting contextual variation. This new knowledge provides the essential basis for the (now underway) development of urgently needed practical and implementable interventions for this underserved population.

Clinician Administered and Self-Report Survey Both Effective for Identifying Fecal Incontinence in Patients with Inflammatory Bowel Disease.

OBJECTIVES: To test two methods for reporting of fecal incontinence (FI) in people with inflammatory bowel disease. METHODS: Consecutive patients from IBD clinics in six UK hospitals completed a short three-item case-finding survey about FI; they either completed the survey themselves or were asked the same questions face to face by a clinician. RESULTS: Of 1336 eligible patients with complete data (48% male; mean 43 years; 55% Crohn's disease, 41% ulcerative colitis), 772 were asked about FI face to face, and 564 self-completed the survey: FI was reported in 63% and 56%, respectively (p = 0.012). In regression analyses, those aged 51-60, having Crohn's disease and higher disease activity, were more likely to report FI. Of all respondents, 38.7% were interested in receiving help for their incontinence. CONCLUSIONS: Fecal incontinence affects the majority of people with IBD. Although more patients reported fecal incontinence when asked face to face than self-reported, routine screening by either method in clinical practice is recommended. Over one-third of patients with IBD want help for bowel control problems.

An International Continence Society (ICS) report on the terminology for single-use body worn absorbent incontinence products.

AIMS: In 2016, the International Continence Society (ICS) Standardization Steering Committee appointed a working group to address the confusing plethora of synonyms currently used to describe single-use body worn absorbent incontinence products by recommending preferred terminology. METHODS: An online questionnaire was posted in 2016/17 inviting input from stakeholders internationally. The data were analyzed and conclusions progressively refined through working group discussions, an open meeting at the 2017 annual ICS conference, and a review of further iterations-including from the parent ICS Standardization Committee-until consensus was reached. Partway in, the International Organization for Standardization started a project with similar scope and the two organizations liaised to harmonize their conclusions while respecting each other's processes. RESULTS: A hundred people from 18 countries responded to the questionnaire. About a third (32.2%) of those declaring their nationality were from the UK and a further third (34.5%) from other English-speaking countries. Two-thirds (67.8%) lived in Europe; around a quarter (23%) in North America; and 9.2% in Australasia. Seven main design categories of products were identified and, while clear consensus was readily achieved in naming some of them, others required more work to determine the best term among multiple contenders. CONCLUSIONS: The working group concluded that the seven product design categories should be called: (a) pads; (b) unbacked pads; (c) male pads; (d) male pouches; (e) pull-on pads (protective underwear); (f) all-in-ones (wrap-around pads, adult briefs); and (g) belted pads (belted products), in which the bracketed terms are judged acceptable (though not preferred) alternatives.

An effective evidence-based cleaning method for the safe reuse of intermittent urinary catheters: In vitro testing.

AIMS: To determine a safe bactericidal cleaning method that does not damage urethral catheters used for intermittent catheterization. In some countries, single-use catheters are the norm; in others, the reuse of catheters is common depending on health insurance, personal preference, or individual concerns about the environment. However, no recent study of cleaning methods has been published to provide evidence for the safe reuse of catheters. METHODS: Using advanced microbiological methods, a laboratory study of eight cleaning methods was conducted. Sections of uncoated polyvinylchloride (PVC) catheters were exposed to bacterial uropathogens in physiologically correct artificial urine media then tested with a range of heat, chemical, and mechanical cleaning methods. Analysis of culturable and viable but nonculturable (VBNC) bacteria was done and direct microscopy was used. Descriptive statistics were used to compare values. RESULTS: Heat treatments, although effective, resulted in catheter surface breakdown and damage. Ultrasonic cleaning and vinegar showed evidence of VBNC populations indicating the methods were bacteriostatic. Detergent and water wash followed by immersion in a commercially available 0.6% sodium hypochlorite solution and 16.5% sodium chloride (diluted Milton) gave consistent bactericidal results and no visible catheter damage. CONCLUSIONS: Combined mechanical and chemical treatment of a detergent and water wash followed by immersion in diluted Milton (the "Milton Method") provided consistent and effective cleaning of uncoated PVC catheters, showing bactericidal action for all uropathogens tested after repeated exposure. If found safe in clinical testing, this method could increase the reuse of catheters, reduce plastic waste in the environment, reduce cost, and increase patient choice.

Development and randomised controlled trial of a Continence Product Patient Decision Aid for men postradical prostatectomy.

AIMS AND OBJECTIVES: To develop and evaluate an evidence-based Continence Product Patient Decision Aid (CP-PDA) to reduce decisional conflict and support continence product choice for men postradical prostatectomy. BACKGROUND: In 2018, 1.3 million men globally were diagnosed with prostate cancer. A common treatment is radical prostatectomy, usually leading to sudden onset of urinary incontinence. For people experiencing incontinence, products to contain leakage are fundamental to health-related quality of life, but many product users and healthcare professionals are unaware of available options. No evidence-based guidance on choosing products exists despite known physical and psychological burdens of poorly managed leakage (e.g. isolation, anxiety, depression, skin damage). DESIGN AND METHODS: 4 phases, underpinned by international decision aid guidance. Evidence/expert opinion: Literature review; consultation with specialist continence clinicians (n = 7) to establish evidence base. Prototype: CP-PDA developed with continence specialist (n = 7) feedback. Alpha testing (stakeholders): CP-PDA materials were provided to expert patients (n = 10) and clinicians (n = 11) to assess content/presentation. Beta testing (field) following CONSORT guidelines, registered NIHR CPMS 31077: Men (n = 50) postradical prostatectomy randomised to evaluate usability and decision-making using the Decisional Conflict Scale compared with usual care. RESULTS: An algorithm differentiating patients by mobility, dependency, cognitive impairment and type/level of leakage, leading to 12 user groups, was developed. For each group, an option table and associated product information sheets guide product choice. Total Decisional Conflict Score for men using the CP-PDA was significantly better than for men without. CP-PDA users reported greater confidence in product knowledge and choice. CONCLUSION: This is the first evidence-based CP-PDA, developed using an internationally recognised method. Compared to usual care, it significantly reduced decisional conflict for men choosing continence products postprostatectomy. RELEVANCE TO CLINICAL PRACTICE: The CP-PDA provides nurses with the first comprehensive, evidence-based intervention to help postprostatectomy men in complex continence product choices. An online version is available: www.continenceproductadvisor.org.