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.

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.

Real world use of oral treatments in interstitial cystitis/bladder pain syndrome in the UK: Outcome of a cross sectional study.

BACKGROUND: To describe the oral treatments people living with interstitial cystitis/bladder pain syndrome (IC/BPS) are using to treat their urologic condition in the UK. METHOD: A questionnaire hyperlink encompassing current and previous medications taken for IC/BPS with other sociodemographic and diagnostic indices was available to the Bladder Health UK website. Interested and fully consented individuals accessed and completed the survey. RESULTS: A total of 601 accessed the questionnaire of whom 173 participants responded (response rate: 28.7%) with a mean ± SD O'Leary/Sant scores of 20.12 ± 9.38. A sample size of 171 was estimated to be used in the survey. A fifth of the participants were not on any treatment at all. Amitriptyline was the most prevalent medication in use both alone and in combination. A shift in the use of unapproved (for IC/BPS) antidepressant, smooth muscle relaxant, opioids, gabapentenoids, and antibiotics was observed in the sample. There were no significant differences between the mean (SD) O'Leary/Sant scores of cohorts currently taking oral medications and those not taking it. More than two-thirds of the participants had been diagnosed with the disease more than 5 years. Just under a half (47.4%) of participants reported a history of allergy. CONCLUSION: Our study provides contemporary evidence that the treatments used for managing IC/BPS encompass a broad range of medications both recommended and not recommended by current guidelines. The latter suggests patients are willing to try novel treatments when more conventional ones are ineffective.

Enablers and barriers to progressing a clinical academic career in nursing, midwifery and allied health professions: A cross-sectional survey.

AIMS AND OBJECTIVES: This study aimed to understand the routes by which nurses, midwives and allied health professionals (NMAHPs) pursue and sustain a research career and the enablers and barriers to career progression. BACKGROUND: Robust evidence is central to practice and professional decision making of NMAHPs, with generation and translation of research arguably best led by those clinically active. Whilst countries like the UK and USA have fellowship schemes to support research career development, anecdotal reports suggest barriers exist in translating these opportunities into sustainable clinical academic careers. DESIGN: Online survey. METHODS: An online questionnaire addressing career choices, facilitators/barriers and support was emailed to 1074 past applicants (doctoral and post-doctoral) to National Institute of Health Research fellowship schemes (awarded and rejected) in England between March and May 2017; 231 responded (25.6%). Study reporting adheres to STROBE checklist. RESULTS: Overall, 134 doctoral and 96 post-doctoral applicants participated; two-thirds were from allied health professions. Most were early in their research career. Interest in research was most frequently sparked by interaction with people in research positions. Nearly half had their first research experience during their BSc project; though less often for nurses/midwives/health visitors (37.5%) than other NMAHPs (51.6%). The award of a fellowship resulted in higher likelihood of being research-active (doctoral level). Nearly three quarters pursuing a clinical academic career indicated 'clearer career paths' and 'greater integration across clinical and academic departments' were desirable. Most common barriers related to research roles, availability of positions and funding. CONCLUSIONS: Fellowship schemes are important to NMAHPs' research careers, but there are serious challenges to establishing and sustaining a career. RELEVANCE TO CLINICAL PRACTICE: Lack of a clear model of career progression, at national and local level, and barriers to creating joint posts impacts on capacity of clinical academics to strengthen integration of research with practice.

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.

The relationship between illness perception and worsening of interstitial cystitis/painful bladder syndrome symptoms: A cross-sectional study.

OBJECTIVE: To evaluate disease perception in a cohort of patients with interstitial cystitis/painful bladder syndrome (IC/PBS) using the Brief Illness Perception-Questionnaire (BIP-Q) and to evaluate how this might relate to disease severity. MATERIALS AND METHODS: The study is a cross-sectional survey amongst members of Bladder Health UK who had previously received a clinical diagnosis of IC/PBS. A hyperlink containing the questionnaire was sent to the patient group's website and interested members accessed and completed the survey. Participants' inclusion was based on a prior clinical diagnosis of IC/PBS, current O'Leary Sant scores supportive of the diagnosis, and age between 18 and 80. A sample size of 171 was used in the study. The Brief Illness Perception Questionnaire (BIP-Q) and the O'Leary/Sant symptoms and problem indices questionnaire were used to collect data. A multivariable logistic regression analysis was used to test the relationship between items of BIP-Q and severity of IC/PBS. Content analysis was used for the causal domain and subsequently analysed as percentages. RESULTS: Six hundred and one members accessed the questionnaire of whom 159 returned completed questionnaires. One hundred and twenty-two of 159 (≥75%) respondents believe that their illness will continue indefinitely. The majority of the respondents indicated that IC/PBS had a negative impact on their daily lives, caused them worry and made them emotionally unstable. Of the 8 BIP-Q items, those most predictive of disease severity were (adjusted odd ratio and confidence intervals): consequence 0.094 (0.023-0.386); treatment control 2.702 (1.256-5.812); identity 0.141 (0.033-0.600); concern 9.363 (1.521-57.632). CONCLUSIONS: Our findings show that IC/PBS negatively impacts participant's quality of life and emotional wellbeing. Higher expectation for treatment benefit and increasing levels of patient concern are predictive for severity of IC/PBS.

Reuse of intermittent catheters: a qualitative study of IC users' perspectives.

OBJECTIVES: To explore the views of intermittent catheter (IC) users regarding the advantages and disadvantages of single-use or reuse of catheters. DESIGN: Qualitative study with semi-structured interviews. The interviews were recorded, transcribed and analysed thematically. SETTING: Participant's own homes in Hampshire and Dorset, UK. PARTICIPANTS: A convenience sample of 39 IC users, aged 23-86 years, using IC for at least 3 months. RESULTS: The analysis revealed four main themes: concerns regarding risk of urinary tract infection (UTI); cleaning, preparation and storage; social responsibility; practicalities and location. The main concern was safety, with the fear that reuse could increase risk of UTI compared with single-use sterile catheters. If shown to be safe then around half of participants thought they might consider reusing catheters. The practicalities of cleaning methods (extra products, time and storage) were considered potentially burdensome for reuse; but for single-use, ease of use and instant usability were advantages. Always having a catheter without fear of 'running out' was considered an advantage of reuse. Some participants were concerned about environmental impact (waste) and cost of single-use catheters. The potential for reuse was usually dependent on location. The analysis showed that often the disadvantages of single-use could be off-set by the advantages of reuse and vice versa, for example, the need to take many single-use catheters on holiday could be addressed by reuse, while the burden of cleaning would be obviated by single-use. CONCLUSIONS: If shown to be safe with a practical cleaning method, some participants would find reuse an acceptable option, alongside their current single-use method. The choice to use a mixture of single-use and reuse of catheters for different activities (at home, work or holiday) could optimise the perceived advantages and disadvantages of both. The safety and acceptability of such an approach would require testing in a clinical trial.

Intermittent catheter users' symptom identification, description and management of urinary tract infection: a qualitative study.

OBJECTIVES: To elucidate the views of intermittent catheter (IC) users regarding urinary tract infection (UTI) symptom presentation, terminology for describing signs and symptoms, the cause of UTI and management strategies. DESIGN: Qualitative study with semi-structured interviews. The transcribed text was analysed thematically. SETTING: 12 general practitioner (GP) surgeries in Hampshire and Dorset, UK. PARTICIPANTS: A convenience sample of 30 IC users, aged over 18, using IC for at least 3 months who had at least one self-reported UTI since starting IC. RESULTS: Participants reported a variety of signs and symptoms, such as urine cloudiness and smell, as indicators of UTI. The terms used often differed from those in the modified National Institute on Disability and Rehabilitation Research (NIDRR) symptom set. IC users had difficulty distinguishing possible UTI symptoms from those of their comorbidities. They expressed uncertainty about the cause of UTI, often attributing it to poor hygiene and lifestyle behaviours. Whereas some viewed UTI as an expected consequence of IC use that could be self-managed, others felt more concerned and were more reliant on their GP for support. A range of management strategies was described, including drinking more fluids, increased attention to personal hygiene and self-medicating with antibiotics. CONCLUSIONS: There is uncertainty among IC users about UTI signs and symptoms and when to seek help. Individual accounts of UTI fitted generally within the modified NIDRR descriptors but adopted less technical and more 'lay' language. IC users' descriptions of UTI signs and symptoms can lack precision, owing partly to the presence of underlying health conditions. This, together with differing levels of concern about the need to seek help and self-medication with antibiotics, presents challenges for the GP. This study provides the basis for developing a self-help tool which may aid identification of UTI and enhance communication with healthcare professionals.

Community prevalence of long-term urinary catheters use in England.

OBJECTIVES: To calculate the prevalence of long term catheter use in the community in two areas in the south and west of England. SUBJECTS/PATIENTS (OR MATERIALS) AND METHODS: People in England register with general practices to access health care through a National Health Service. Catheters are provided by prescription free of charge. In 2008, patients using urinary catheters for over 3 months were identified, and demographic information collected, from databases of general practices, using catheter prescribing records. The age and sex distributions of people in each practice were obtained from capitation claims. Overall, and age and sex-specific prevalence were calculated separately for each area, and compared. RESULTS: A total of 583 long term catheter users (329 south, 254 west) were identified from 404,328 people registered with practices. The overall population prevalence is similar in both locations (0.146% southern, 0.141% western). Extrapolating for the United Kingdom, this is over 90,000 long term catheter users. Prevalence increases with age (0.732% in over 70 years, 1.224% over 80), especially amongst men. Overall, higher proportions have neurological (vs. non-neurological) reasons (62.9% vs. 37.1%) and use urethral (vs. suprapubic) catheters (59.7% vs. 40.3%). Compared to men, more women tend to use suprapubic (56.4% vs. 29.3%) and have a catheter for neurological reasons (71.8% vs. 56.2%, P = 0.053). CONCLUSIONS: Previous evidence on prevalence of long term catheter use is sparse, and of variable quality. The strength of this study is utilisation of a reliable source of data (catheter prescriptions) from a large population of patients. Neurourol. Urodynam. 36:293-296, 2017. © 2016 Wiley Periodicals, Inc.

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

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

Age and cigarette smoking are independently associated with the cutaneous vascular response to local warming.

PURPOSE: To investigate the relative impacts of age and cigarette smoking on cutaneous blood flow and flow motion. EXPERIMENTAL DESIGN: Skin blood flux was measured before and during the hyperaemic response to thermal warming of the skin to 43 degrees C using laser Doppler fluximetry (LDF) in 28 habitual smokers (5.4 [11.4] (median [IQR]) pack years; pack years = packs/day x duration of smoking habit), aged between 18 and 63 years and their age, sex and body mass index. Flow motion was assessed using Fourier analysis of the LDF signal. RESULTS: Mean and total hyperaemic (area under the flux curve, AUC(10)) response during warming were reduced in smokers compared with their non-smoking controls (P<0.05). Attenuation of the response to warming in smokers was associated with a reduction in relative spectral power around 0.01 Hz, reflecting a reduced endothelial/metabolic activity (P<0.04). In regression modelling with AUC(10) as the outcome, and smoking (yes/no), age, sex and BMI, as explanatory variables, age (P<0.0001) and smoking (P=0.018) were independently associated with the hyperaemic response and together accounted for 31% of the variance in AUC(10). CONCLUSIONS: Age and smoking are associated with approximately one-third of the variance in the endothelium-associated microvascular vasomotor activity in habitual smokers.