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

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

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

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

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

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.

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.

'They Talked Completely about Straight Couples Only': Schooling, Sexual Violence and Sexual and Gender Minority Youth.

Scholarly conversations regarding sexual violence and sexuality education typically emphasise cisgender and heterosexual experiences, leaving sexual and gender minority young people's voices unheard. This happens despite adolescence being a crucial period for the onset of sexual violence, with sexual and gender minority youth reporting elevated levels of victimisation. Moreover, the preponderance of research focusing on victimisation suggests notable gaps in our understanding of sexual violence perpetration. This study examined contextual factors shaping sexual violence victimisation and perpetration among sexual and gender minority youth, with school playing a key role. Based on qualitative data from semi-structured interviews with 50 young people aged 14-26 years who self-reported sexual violence perpetration in the Growing Up with Media survey, the analysis demonstrates how schooling's 'hidden curriculum' leaves sexual and gender minority youth ill-equipped to navigate the world of sexuality. Formal sexuality education remains heteronormative and gender-segregated, resulting in incomplete understandings of sexual violence. At the informal level, gendered double standards and peer norms reinforce the second-class sexual citizenship of sexual and gender minority youth. Our findings suggest that schools may be complicit in sexual violence victimisation and perpetration by sending limited and mixed messages regarding gender and sexuality. Research and policy implications are discussed.

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.

Under the spotlight: understanding the role of the Chief Medical Officer in a pandemic.

As the COVID-19 pandemic took hold in 2020, Chief Medical Officers (CMOs) entered the public spotlight like never before. Amidst this increased visibility, the role is deeply contested. Much of the disagreement concerns whether CMOs should act independently of the government: while some argue CMOs should act as independent voices who work to shape government policy to protect public health, others stress that CMOs are civil servants whose job is to support the government. The scope and diversity of debates about the CMO role can be explained by its inherently contradictory nature, which requires incumbents to balance their commitments as physicians with their mandates as civil servants who advise and speak on the government's behalf. The long-haul COVID-19 pandemic has further tested the CMO role and has shone light on its varying remits and expectations across different jurisdictions, institutions and contexts. It is perhaps unsurprising, then, that calls to amend the CMO role have emerged in some jurisdictions during the pandemic. However, any discussions about changing the CMO role need a stronger understanding of how different institutional and individual approaches impact what incumbents feel able to do, say and achieve. Based on an ongoing comparative analysis of the position across five countries with Westminster-style political systems, we provide an overview of the CMO role, explain its prominence in a pandemic, examine some debates surrounding the role and discuss a few unanswered empirical questions before describing our ongoing study in greater detail.

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.

Comparing Factors Shaping Sexual Violence Perpetration for Sexual and Gender Minority Youth and Cisgender Heterosexual Youth.

Sexual and gender minority (SGM) youth experience higher rates of sexual violence victimization than their cisgender heterosexual counterparts. Very little is known about how the minority status of SGM youth contextualizes their victimization and perpetration experiences. In one-on-one interviews with 39 SGM youth and 11 cisgender heterosexuals (non-SGM) youth, we compared the contextual factors shaping sexual violence victimization and perpetration between the two groups using a qualitative descriptive approach. Interviews highlighted how SGM youth continue to experience extensive discrimination that negatively impacts all aspects of their lives, while non-SGM youth do not discuss having to navigate stigma and discrimination in their lives. SGM youth pointed to a lack of understanding of sexual violence within the SGM community. Both groups believed that SGM perpetration was unlikely: while most SGM and non-SGM youth agreed that sexual violence between youth was a problem, same-gender perpetration was seldom discussed. Unlike their non-SGM counterparts, SGM youth felt that they were targeted because of their sexual and gender identity. SGM youth also felt that they were more vulnerable to sexual violence because of how they physically looked, particularly if their gender expression did not match cis-normative expectations. SGM youth reported facing unique pressures when seeking support as a victim, particularly a fear of being outed or stigmatized as part of the process. They also conveyed that SGM people worried about being treated unfairly if they reported sexual violence to authorities. Findings suggest that stigma and concerns of discrimination are unique aspects of sexual violence for SGM compared to non-SGM youth. All youth need to have access to sexual violence prevention education that includes SGM and non-SGM youth as both victims and perpetrators to begin addressing these noted disparities in experiences.

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.

Experiences of surgery readiness assessments in British Columbia.

Background: A surgical readiness assessment is a major step in the medical journey of trans people seeking gender-affirming surgery. Much of the peer-reviewed literature surrounding surgical readiness assessments emphasizes the perspectives of academics and clinicians, leaving the voices of trans and gender diverse patients largely unheard. Aims: This paper foregrounds patient experiences with surgery readiness assessments to discuss the tensions, challenges and opportunities they generate. Methods: We conducted a thematic analysis of 35 in-depth interviews with trans people who accessed or were seeking to access gender-affirming surgery in British Columbia. Results: We developed three main themes to capture participants' narratives of their surgical assessment experiences. The first, assessments as gatekeeping, explores the stories of people who described their assessments as outdated and even discriminatory processes. The second, assessments as a barrier to care, discusses the informational missteps, bureaucratic regulations, economic issues, and geographic concerns that made assessments difficult to access. The third, assessments as useful, includes positive stories about assessments that often involved feeling supported by an assessor and feeling prepared for the next steps. Discussion: These narratives demonstrate how much variation exists among people's experiences of readiness assessments for gender-affirming surgery. No matter how their actual assessment turned out, many participants approached their appointments with a great deal of anxiety and trepidation. We attributed this stress was to challenges ranging from lengthy wait times, arbitrary medical gatekeeping, a lack of access to knowledgeable and supportive providers, unclear or changing administrative processes, and insufficient communication. To address these challenges, it is crucial for the medical system to create more accessible pathways with centralized, up-to-date information for people trying to access assessments. Patients are best served by multi-disciplinary gender-affirming teams that provide individualized care.

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.

TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial.

BACKGROUND: Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men presenting with LUTS are managed by their general practitioner (GP) in the first instance, with conservative therapies recommended as the initial treatment. However, the provision of conservative therapies in primary care is variable and can be time and resource limited. GPs require practical resources to enhance patient engagement with such interventions. TRIUMPH aims to determine whether a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for LUTS versus usual care. METHODS/DESIGN: TRIUMPH is a two-arm, cluster randomised controlled trial (RCT) being conducted in 30 National Health Service (NHS) general practices in England. The TRIUMPH intervention comprises a standardised LUTS advice booklet developed for the trial with patient and healthcare professional (HCP) consultation. The booklet is delivered to patients by nurses/healthcare assistants following assessment of their urinary symptoms. Patients are directed to relevant sections of the booklet, providing the manualised element of the intervention. To encourage adherence, HCPs provide follow-up contacts over 12 weeks. Practices are randomised 1:1 to either deliver the TRIUMPH intervention or a usual care pathway. The patient-reported International Prostate Symptom Score (IPSS) at 12 months post consent is the primary outcome. Secondary outcomes include cost-effectiveness, patient-reported outcomes on LUTS, quality of life, and patient and HCP acceptability and experience of the intervention. Primary analyses will be conducted on an intention-to-treat basis. DISCUSSION: It is unclear whether conservative therapies for male LUTS are effectively delivered in primary care using current approaches. This can lead to men being inappropriately referred to secondary care or experiencing persistent symptoms. Primary care, therefore, holds the key to effective treatment for these men. The TRIUMPH intervention, through its standardised and manualised approach, has been developed to support GP practices in delivering effective conservative care. This pragmatic, cluster RCT should provide robust evidence in a primary-care setting to inform future guidelines. TRIAL REGISTRATION: ISCRTN registry, ID: ISRCTN11669964 . Registered on 12 April 2018.

Tissue response to applied loading using different designs of penile compression clamps.

Background: Penile compression devices (PCD) or clamps are applied to compress the urethra and prevent urinary incontinence (UI). PCDs are more secure and less likely to leak than pads, allowing men the opportunity to participate in short-term, vigorous activities. However, they are uncomfortable, can cause pressure ulcers (PU) and affect penile blood flow. No objective assessment of tissue health has been undertaken to assess and compare different PCD designs and to provide guidance on safe use. Objective: This study was designed to evaluate existing PCDs in terms of their physiological response and potential for pressure-induced injury. Design, setting and participants: Six men with post-prostatectomy UI tested four selected PCDs at effective pressures, in a random order, in a controlled laboratory setting. Outcome measurements and statistical analysis: Using objective methods for assessing skin injury, PCDs were measured in situ for their effects on circulatory impedance, interface pressures and inflammatory response. Results and limitations: There was evidence for PCD-induced circulatory impedance in most test conditions. Interface pressures varied considerably between both PCDs and participants, with a mean value of 137.4±69.7 mmHg. In some cases, penile skin was noted to be sensitive to loading with elevated concentration of the cytokine IL-1α after 10 mins wear, indicating an inflammatory response. IL-1α levels were restored to baseline 40 mins following PCD removal. Conclusion: Skin health measures indicated tissue and blood flow compromise during the 50 mins of testing using all PCDs. Although there was an elevation in pro-inflammatory cytokines, PCDs did not cause sustained irritation and skin health measures recovered 40 mins after PCD removal. This research indicates that application of a clamp for one hour with an equal clamp free time before reapplication is likely to be safe. Longer periods are often recommended by manufacturers but have yet to be tested.

An investigation of laboratory test methods for predicting the in-use leakage performance of urine-absorbing aids in nursing homes.

The absorption before leakage method for measuring the absorption capacity of urine-absorbing aids was investigated. Along with the existing international standard (ISO 11948-1:1996, the Rothwell method), it was run on 12 experimental products whose in-use leakage performance was established by 55 incontinent nursing home residents. Methods were evaluated by considering their simplicity, their repeatability within - and their reproducibility between - six laboratories, and their correlation with in-use product performance. ISO 11948-1:1996 - which measures the absorption capacity of products under simple conditions - showed good repeatability and reproducibility, and reasonable correlation with in-use data. However, it proved blind to the effects of leg cuffs that conferred measurable benefits in real use. It should, therefore, be used with caution. The absorption before leakage method - which measures how much a product will hold before leakage when it is mounted on a manikin and standard aliquots of liquid are applied - is more complex and had poorer repeatability and reproducibility. However, it had stronger correlations with in-use data and successfully detected the benefits of leg cuffs on insert products. It is concluded that it holds potential as a new international standard to replace or complement ISO 11948-1:1996, and the necessary refinement work has been ongoing since the 2007 project described here. Two other laboratory methods were run opportunistically. A rewet method (Spanish national standard UNE 153601-2:2008) - for measuring the escape of fluid from a product under pressure - showed poor repeatability and reproducibility. Finally, an acquisition method was used to measure how quickly products absorbed two successive standard aliquots of liquid. It proved robust, showing good repeatability and reproducibility. Although measurements generally correlated well with in-use leakage performance, a direct causal link is unlikely. Products with high absorption capacity tend also to absorb quickly.

Use of an occlusive penile clamp during filling cystometry in men with symptoms of stress urinary incontinence.

OBJECTIVE: In severe post-prostatectomy stress urinary incontinence (SUI), urodynamics may not identify crucial parameters because of inadequate bladder filling. This study evaluated cystometry and pressure flow studies (PFS) in men in whom severe SUI during attempted filling necessitated application of a penile clamp to allow filling to reach cystometric capacity. Men who had undergone prior radical prostatectomy were identified from a database of patients attending for video urodynamic testing between 2012 and 2017. Symptom scores, bladder diary and free flow rate tests were retrieved. Measurements of the subgroup of men for whom a Thomson-Walker compression clamp was used to enable full urodynamic evaluation were evaluated. 166 patients were identified. In 30 patients (18%), severe SUI led to incomplete filling cystometry. Following application of the penile compression clamp, further filling was achieved in each case. Applying the clamp did not alter vesical filling or impede pressure recording. These men had a lower maximum urethral closure pressure (31.6 vs. 46.5 cm H2 O; P < 0.001), volume at strong desire to void (132 vs. 242 mL; P = 0.003) and cystometric capacity (226 mL with clamp applied vs. 310 mL; P < 0.001) than the overall post-prostatectomy incontinence population. Flow rates during PFS were comparable, but detrusor pressure at maximum flow was lower in the clamp group (11 vs. 22 cm H2 O; P = 0.009). A penile clamp applied at the time when leakage becomes excessive during filling cystometry avoids premature test termination in men with severe incontinence.

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.