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.

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.

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.

Continuous low-dose antibiotic prophylaxis to prevent urinary tract infection in adults who perform clean intermittent self-catheterisation: the AnTIC RCT.

BACKGROUND: People carrying out clean intermittent self-catheterisation (CISC) to empty their bladder often suffer repeated urinary tract infections (UTIs). Continuous once-daily, low-dose antibiotic treatment (antibiotic prophylaxis) is commonly advised but knowledge of its effectiveness is lacking. OBJECTIVE: To assess the benefit, harms and cost-effectiveness of antibiotic prophylaxis to prevent UTIs in people who perform CISC. DESIGN: Parallel-group, open-label, patient-randomised 12-month trial of allocated intervention with 3-monthly follow-up. Outcome assessors were blind to allocation. SETTING: UK NHS, with recruitment of patients from 51 sites. PARTICIPANTS: Four hundred and four adults performing CISC and predicted to continue for ≥ 12 months who had suffered at least two UTIs in the previous year or had been hospitalised for a UTI in the previous year. INTERVENTIONS: A central randomisation system using random block allocation set by an independent statistician allocated participants to the experimental group [once-daily oral antibiotic prophylaxis using either 50 mg of nitrofurantoin, 100 mg of trimethoprim (Kent Pharmaceuticals, Ashford, UK) or 250 mg of cefalexin (Sandoz Ltd, Holzkirchen, Germany); n = 203] or the control group of no prophylaxis (n = 201), both for 12 months. MAIN OUTCOME MEASURES: The primary clinical outcome was relative frequency of symptomatic, antibiotic-treated UTI. Cost-effectiveness was assessed by cost per UTI avoided. The secondary measures were microbiologically proven UTI, antimicrobial resistance, health status and participants' attitudes to antibiotic use. RESULTS: The frequency of symptomatic antibiotic-treated UTI was reduced by 48% using prophylaxis [incidence rate ratio (IRR) 0.52, 95% confidence interval (CI) 0.44 to 0.61; n = 361]. Reduction in microbiologically proven UTI was similar (IRR 0.49, 95% CI 0.39 to 0.60; n = 361). Absolute reduction in UTI episodes over 12 months was from a median (interquartile range) of 2 (1-4) in the no-prophylaxis group (n = 180) to 1 (0-2) in the prophylaxis group (n = 181). The results were unchanged by adjustment for days at risk of UTI and the presence of factors giving higher risk of UTI. Development of antimicrobial resistance was seen more frequently in pathogens isolated from urine and Escherichia coli from perianal swabs in participants allocated to antibiotic prophylaxis. The use of prophylaxis incurred an extra cost of £99 to prevent one UTI (not including costs related to increased antimicrobial resistance). The emotional and practical burden of CISC and UTI influenced well-being, but health status measured over 12 months was similar between groups and did not deteriorate significantly during UTI. Participants were generally unconcerned about using antibiotics, including the possible development of antimicrobial resistance. LIMITATIONS: Lack of blinding may have led participants in each group to use different thresholds to trigger reporting and treatment-seeking for UTI. CONCLUSIONS: The results of this large randomised trial, conducted in accordance with best practice, demonstrate clear benefit for antibiotic prophylaxis in terms of reducing the frequency of UTI for people carrying out CISC. Antibiotic prophylaxis use appears safe for individuals over 12 months, but the emergence of resistant urinary pathogens may prejudice longer-term management of recurrent UTI and is a public health concern. Future work includes longer-term studies of antimicrobial resistance and studies of non-antibiotic preventative strategies. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67145101 and EudraCT 2013-002556-32. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 22, No. 24. See the NIHR Journals Library website for further project information.

Managing Faecal INcontinence in people with advanced dementia resident in Care Homes (FINCH) study: a realist synthesis of the evidence.

BACKGROUND: Eighty per cent of care home residents in the UK are living with dementia. The prevalence of faecal incontinence (FI) in care homes is estimated to range from 30% to 50%. There is limited evidence of what is effective in the reduction and management of FI in care homes. OBJECTIVE: To provide a theory-driven explanation of the effectiveness of programmes that aim to improve FI in people with advanced dementia in care homes. DESIGN: A realist synthesis. This was an iterative approach that involved scoping of the literature and consultation with five stakeholder groups, a systematic search and analysis of published and unpublished evidence, and a validation of programme theories with relevant stakeholders. DATA SOURCES: The databases searched included PubMed, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library, Scopus, SocAbs, Applied Social Sciences Index and Abstracts, BiblioMap, Sirius, OpenGrey, Social Care Online and the National Research Register. RESULTS: The scoping identified six programme theories with related context-mechanism-outcome configurations for testing. These addressed (1) clinician-led support, assessment and review, (2) the contribution of teaching and support for care home staff on how to reduce and manage FI, (3) the causes and prevention of constipation, (4) how the cognitive and physical capacity of the resident affect outcomes, (5) how the potential for recovery, reduction and management of FI is understood by those involved and (6) how the care of people living with dementia and FI is integral to the work patterns of the care home and its staff. Data extraction was completed on 62 core papers with iterative searches of linked literature. Dementia was a known risk factor for FI, but its affect on the uptake of different interventions and the dementia-specific continence and toileting skills staff required was not addressed. Most care home residents with FI will be doubly incontinent and, therefore, there is limited value in focusing solely on FI or on single causes of FI such as constipation. Clinical assessment, knowledge of the causes of FI and strategies that recognise the individuals' preferences are necessary contextual factors. Valuing the intimate and personal care work that care home staff provide to people living with dementia and addressing the dementia-related challenges when providing continence care within the daily work routines are key to helping to reduce and manage FI in this population. LIMITATIONS: The synthesis was constrained by limited evidence specific to FI and people with dementia in care homes and by the lack of dementia-specific evidence on continence aids. CONCLUSIONS: This realist synthesis provides a theory-driven understanding of the conditions under which improvement in care for care home residents living with dementia and FI is likely to be successful. FUTURE WORK: Future multicomponent interventions need to take account of how the presence of dementia affects the behaviours and choices of those delivering and receiving continence care within a care home environment. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014009902. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

An Exploratory Study of Skin Problems Experienced by UK Nursing Home Residents Using Different Pad Designs.

PURPOSE: The primary aim of this study was to determine whether the severity of incontinence-associated dermatitis (IAD) among nursing home-based incontinence pad users varies between pad designs. A second aim was to examine the utility of a simple method for reporting skin health problems in which healthcare assistants were asked to record basic observational data at each pad change. STUDY DESIGN: Randomized, multiple crossover, observational, exploratory. SUBJECTS AND SETTING: Twenty-one men and 57 women using absorbent continence products to contain urinary and/or fecal incontinence were recruited from 10 nursing homes in London and the south of England. METHODS: A day-time variant and a night-time variant of each of the 4 main disposable pad designs on the market for moderate/heavy incontinence were tested: (1) insert pads with stretch pants; (2) 1-piece all-in-one diapers; (3) pull-up pants; and (4) belted/T-shape diapers. All pad variants for day-time use had an absorption capacity of 1900 mL ± 20% (measured using ISO 11948-1 International Standards Organization) while the capacity of night-time variants was 2400 mL ± 20%. Each resident used each of the 4 pad designs (day-time and night-time variants) for 2 weeks and the order of testing was randomized by nursing home. Skin health data were collected using 2 methods in parallel. Method 1 comprised visual observation by researchers (1 observation per pad design; 4 observations in total over 8 weeks). In method 2, healthcare assistants logged observational data on skin health at every pad change for the 8 weeks. The primary outcome variable was severity of the most severe skin problem noted by the researcher for each resident, and for each pad design (method 1). Descriptive data on skin care methods used in the nursing homes were also collected using short questionnaires and researcher observation. RESULTS: No significant differences in the severity or incidence of skin problems were found between observations using the 4 pad designs. However, a wide range of skin conditions was recorded that made classification difficult; the skin was often marked with creases from absorbent products, temporary marks, and pink/purple discoloration. We observed few cases of the severe erythema, rashes, and vesicles that are commonly used descriptors in previous skin tools. Nevertheless, the collected data reflect an abundance of skin problems that were difficult to categorize neatly. Researcher observations (method 1) showed that nearly all the residents (96%) had at least 1 IAD skin problem recorded over the 8-week period and 64% of residents had at least 1 problem that was rated as maximum severity. Healthcare assistants logged skin problems on 6.1% of pad changes. The discrepancy between researcher and healthcare assistant data appears to be largely due to healthcare assistants sometimes discounting low-grade IAD as normal for that population. CONCLUSION: Incontinence-associated dermatitis is common among nursing home residents who use incontinence pads, and it is often severe. No evidence was found that any design of pad was more likely than any others to be associated with skin problems. The method devised to enable healthcare assistants to record basic observational data on skin health in the diaper area at each pad change (Method 2) proved simple to use but still resulted in substantial underreporting of IAD, suggesting that further work is needed to develop a tool that more successfully encourages them to log and treat IAD problems.

Is it Feasible to Use Incontinence-Associated Dermatitis Assessment Tools in Routine Clinical Practice in the Long-term Care Setting?

PURPOSE: To investigate the feasibility of using incontinence-associated dermatitis (IAD) tools in routine clinical practice by asking nursing home staff (RNs and non-RN caregivers) and tissue viability specialty (TVS) nurses to evaluate 3 instruments and a 4-point severity scoring system for describing and grading IAD examples captured in photographs of skin underneath absorptive pads in nursing home patients. DESIGN: Feasibility study. SUBJECTS AND SETTING: Twelve female nursing home residents whose incontinence was managed with pads and who had previously been identified as experiencing IAD were recruited, along with 16 nursing home staff (6 RNs and 10 non-RNs) and 10 TVS nurses. METHODS: Weekly high-quality photographs were taken of the skin beneath absorptive pads of nursing home residents for 8 weeks yielding a library of 78 photographs. A subset of 10 representative photographs was chosen. The 16 nursing home staff and 10 TVS nurses were then asked to describe and grade the IAD in the 10 photographs using 3 IAD instruments and simple severity scoring system (SSS) developed for this study. Particular attention was paid to identifying any practical challenges staff encountered in conducting their task. RESULTS: The TVS nurses were able to use all 3 IAD instruments and the SSS and reported that they could incorporate them into their clinical practice with relative ease. Although the RNs were able to use the 3 instruments adequately with some initial assistance, they generally felt that they were too busy to complete them. By contrast, they reported that they found the SSS simple and quick enough to incorporate into their routine practice. The caregivers had difficulty with the text-based instruments, especially if English was not their first language, and they were only able to use the SSS. The caregivers' SSS scores for a given photograph varied more than TVS nurse scores, but the correlation between the mean TVS scores, which were operationally defined as the gold standard for purposes of this study, and the mean RN and caregiver scores (R = 0.811) were fairly high. CONCLUSIONS: Existing IAD instruments are too time-consuming and linguistically complex for use in routine clinical practice in nursing homes. We found that staff generally found the SSS easy to judge IAD severity based on pictures used in the study. This finding suggests that the SSS could be improved by adding reference photographs of skin illustrating each of the 4 points on the scale. Such an instrument could be designed and validated with an emphasis on integration into current clinical practice pathways.

Individual budgets for people with incontinence: results from a 'shopping' experiment within the British National Health Service.

BACKGROUND AND CONTEXT: Most people with urinary incontinence are given limited choice when provided with absorbent products through the British National Health Service (NHS), even though the available range is large. OBJECTIVE: To investigate users' preferences for four disposable designs (inserts, all-in-ones, belted/T-shaped and pull-ups) and towelling washable/reusable products, day and night. DESIGN: Shopping experiment. SETTING AND PARTICIPANTS: Community-dwelling women and men in England with moderate-to-heavy urinary incontinence recruited to a larger trial. INTERVENTION: Participants tested each design and selected products they would prefer with a range of different budgets. MAIN OUTCOME MEASURES: Design preferences (rankings); 'purchasing' decisions from designated budgets. Results Eighty-five participants (49 men) tested products, 75 completed the shopping experiment. Inserts, most frequently supplied by the NHS, were ranked second to pull-ups by women and lowest by men. When faced with budget constraints, up to 40% of participants opted to 'mix-and-match' designs. Over 15 different combinations of products were selected by participants in the shopping experiment. Most (91%) stated a willingness to 'top-up' assigned budgets from income to secure preferred designs. DISCUSSION: Participants displayed diverse preferences. Enabling user choice of absorbent product design through individual budgets could improve satisfaction of consumers and efficiency of allocation of limited NHS resources. CONCLUSION: Recent policy for the NHS seeks to provide consumers with more control in their care. Extension of the concept of individual budgets to continence supplies could be feasible and beneficial for patients and provide better value-for-money within the NHS. Further research is warranted.

Continence products: research priorities to improve the lives of people with urinary and/or fecal leakage.

Although many successful treatments for incontinence exist they are not effective or suitable for all people. Inconspicuous and dependable management with continence products and devices plays a crucial part in maintaining quality of life. We aim to briefly review what is known and not known in the field of continence products and devices and set out suggested priorities for research and development. The field of continence product research encompasses techniques and designs from basic laboratory science, through to clinical trials of products and to evaluations of service delivery models. Priorities for research include determining prevalence and costs of product use, development of patient reported outcomes, and development of methods for measuring skin health and for quantifying urine/faecal leakage. Product development priorities include better washable pads for women, absorbent products for fecal incontinence and flatus filters. Clinical trials of different product categories (e.g., devices for men) are needed, as are qualitative studies of patient experiences of product use.

A noninvasive continence management system: development and evaluation of a novel toileting device for women.

PURPOSE: This paper describes a project to develop and clinically evaluate a novel toileting device for women called the Non-Invasive Continence Management System (NICMS). The NICMS device is designed to provide an alternative toileting facility that overcomes problems some women experience when using conventional female urinals. DESIGN: A single product evaluation was completed; participants used the same device with 1 or 2 interface variants. SUBJECTS AND SETTING: Eighty women from 6 countries who were either mobile or wheelchair dependent evaluated the product over a 15-month period. RESULTS: The device was found to be useful in some circumstances for women and their caregivers. CONCLUSION: Significant further development is required for it to work reliably and to provide an acceptable device in terms of reliability, size, weight, noise, and aesthetics.

Absorbent products for incontinence: 'treatment effects' and impact on quality of life.

AIM: This study aimed to determine how the use and characteristics of absorbent products for incontinence impact on women's quality of life, and to examine the concept of 'treatment effects' in the context of pad use. METHOD: Key pad performance characteristics were identified from the literature and focus group work. Semi-structured interviews with 99 women with light incontinence were used to investigate the impact of pad use on women's quality of life, including both positive and negative 'treatment effects', and to rank pad characteristics by their importance. RESULTS: Achieving effective and discrete containment of urine was the dominant factor impacting on women's lives. Sub-themes embraced physical effects, psychological impact and social functioning. The five pad characteristics ranked most important for day time use were: 'to hold urine, to contain smell, to stay in place, discreteness, and comfort when wet. For night use discreteness was replaced by to keep skin dry'. High levels of reported anxiety were associated with perceived risk of poor pad performance, lack of discreteness and need for complex regimes for pad management. CONCLUSION: Insufficient attention has been paid to the balance between the beneficial and negative treatment effects of absorbent pads to date. Existing continence-related quality of life measures are not designed for conditions where change in symptoms is not an outcome measure. The study findings provide the basis for developing a more sensitive, patient-oriented, quality of life measure for pad-users which can aid product selection, new product development and inform future evaluative comparisons between products/products and treatments. RELEVANCE TO CLINICAL PRACTICE: This paper illustrates the complex influence on quality of life caused by using absorbent pads to contain incontinence. It raises awareness of the importance of careful selection of the most appropriate pad for each individual to minimize unfavourable side effects, and the need for a new quality of life measure designed for pad-users.

Current evidence on intermittent catheterization: sterile single-use catheters or clean reused catheters and the incidence of UTI.

PURPOSE: Intermittent catheterization is a commonly prescribed procedure for people with incomplete bladder emptying not managed by other methods. The most frequent complication of intermittent catheterization is urinary tract infection (UTI). It is unclear what strategies, including sterile vs clean catheters or coated vs uncoated PVC catheters, affect the incidence of UTIs. This systematic review summarizes current evidence on the relationship between sterile single-use catheters or clean reused catheters and the incidence of UTIs. SEARCH STRATEGY: The Cochrane Incontinence Group trials register, Medline, EMBASE, CINAHL, and ERIC were searched, plus the reference lists of relevant articles and conference proceedings. Randomized controlled trials comparing at least two different products or methods for intermittent catheterization were included. DATA COLLECTION AND ANALYSIS: Three reviewers assessed the methodological quality of trials and abstracted data. MAIN RESULTS: Of the 13 trials that met the inclusion criteria on intermittent catheterization protocols, there was considerable variation in length of follow-up, definitions of UTI, and numbers of subjects. Attrition was a problem for several studies, and all were underpowered. Several studies were more than 10 years old, and outcome measures were imprecise, making it difficult to draw conclusions on the benefit of one catheterization method over another. CONCLUSIONS: There are no definitive studies illustrating that incidence of UTIs is affected by sterile single-use or coated catheters compared to clean reused catheters. However the current research base is weak and design issues are significant. Based on the current data, it is not possible to state that one catheter method is better than another and further research on the topic is strongly recommended.

A multi-centre evaluation of absorbent products for men with light urinary incontinence.

AIMS: This study compared the performance of the four main designs of absorbents for men with light incontinence: pouches (shields), leafs (guards), washable pant with integral pad (pantegral), and small disposable pad. MATERIALS AND METHODS: We did a multiple crossover trial. Men with light urinary incontinence were recruited. All pouches and leafs available in the UK were identified for inclusion. A single pantegral and small pad were selected based on previous evaluations for design comparison. Products were tested in random order for up to 1 week. Performance criteria (e.g., leakage and comfort) were rated using a validated product performance questionnaire. Wet product weights and amount of leakage were recorded in pad leakage diaries. "Overall opinion" for design performance was used as the primary outcome indicator. RESULTS: Seventy-four men tested six leafs, six pouches, one pantegral, and one small pad. Leakage data was taken from 3,386 wet pads. The pouches generally performed poorly with few significant differences between products. The leafs were more variable with large and significant differences in ratings. Overall the leaf, pantegral, and small pad designs performed significantly better than the pouch (P

Managing incontinence using technology, devices, and products: directions for research.

BACKGROUND: Millions of Americans with incontinence use some type of device or product to manage or collect urine or feces. However, research on their clinical uses, problems requiring nursing care, and patient satisfaction is lacking. OBJECTIVES: To review the various products and devices used for incontinence, identify directions for research and development on technology, and outline the ways nurses can influence and participate in those investigations. METHODS: Existing literature on incontinence technology, devices, and products was analyzed to generate a plan for future research. RESULTS: Gaps in knowledge exist about the uses, best practices, quality of life factors, and problems associated with catheters, absorbent products, other internal and external devices, and skin care products. CONCLUSIONS: Collaboration among public and private sectors would result in greater likelihood of high quality clinical research that has sufficient power and integrity, more efficient use of resources special to each setting, and expedited application of technologies for patient use.

A pilot study to evaluate reusable absorbent body-worn products for adults with moderate/heavy urinary incontinence.

OBJECTIVE: The purpose of this pilot study was to evaluate the performance of reusable absorbent body-worn products for adults with moderate/heavy urinary incontinence, compare their performance with a group of equivalent disposable products, and establish the need for a larger statistically robust study. SETTING AND SUBJECTS: Ten men and 4 women living in the community were recruited from locations throughout the United Kingdom. METHODS: A randomized multiple crossover design was used in which all subjects were given the opportunity to test each product. All the products were available on the UK market in January 2001. The following tools were used in the evaluation: a product performance questionnaire and a pad leakage diary. Overall opinion was used as the primary outcome indicator. RESULTS: The reusable Paddy T was the best performing product overall, outperforming the disposable products. For low leakage and good absorbency (the most important product attributes identified by the subjects), the disposable all-in-one product performed best during the day. However, the Paddy T performed best for night use. The remaining reusable products performed poorly overall. CONCLUSIONS: Reusable products for moderate/heavy incontinence remain unpopular for use in isolation. Surprisingly, a product manufactured from terry toweling, a traditional material, performed relatively well. Reusables may provide a useful alternative to disposable products in certain circumstances. The results from this study do not support a more comprehensive costly study.