PRImary care Management of lower Urinary tract Symptoms in men: protocol for development and validation of a diagnostic and clinical decision support tool (the PriMUS study)

Abstract

IntroductionLower urinary tract symptoms (LUTS) is a bothersome condition affecting older men which can lead to poor quality of life. General practitioners (GPs) currently have no easily available assessment tools to help effectively diagnose causes of LUTS and aid discussion of treatment with patients. Men are frequently referred to urology specialists who often recommend treatments that could have been initiated in primary care. GP access to simple, accurate tests and clinician decision tools are needed to facilitate accurate and effective patient management of LUTS in primary care.Methods and analysisPRImary care Management of lower Urinary tract Symptoms (PriMUS) is a prospective diagnostic accuracy study based in primary care. The study will determine which of a number of index tests used in combination best predict three urodynamic observations in men who present to their GP with LUTS. These are detrusor overactivity, bladder outlet obstruction and/or detrusor underactivity. Two cohorts of participants, one for development of the prototype diagnostic tool and other for validation, will undergo a series of simple index tests and the invasive reference standard (invasive urodynamics). We will develop and validate three diagnostic prediction models based on each condition and then combine them with management recommendations to form a clinical decision support tool.Ethics and disseminationEthics approval is from the Wales Research Ethics Committee 6. Findings will be disseminated through peer-reviewed journals and conferences, and results will be of interest to professional and patient stakeholders.Trial registration numberISRCTN10327305.

Managing lower urinary tract symptoms in primary care: qualitative study of GPs’ and patients’ experiences

“…Telephone interviews were conducted with GPs and patients from GP practices involved in the PriMUS study 15 across three UK regions: Newcastle upon Tyne, Bristol and South Wales. PriMUS (Primary care Management of lower Urinary tract Symptoms in men: development and validation of a diagnostic and clinical decision support tool) is a prospective diagnostic accuracy study aimed at developing a decision tool to help GPs more accurately diagnose and manage male LUTS.…”

“…PriMUS (Primary care Management of lower Urinary tract Symptoms in men: development and validation of a diagnostic and clinical decision support tool) is a prospective diagnostic accuracy study aimed at developing a decision tool to help GPs more accurately diagnose and manage male LUTS. PriMUS participants are men aged 16 years and over presenting to their GP with a complaint of one or more bothersome LUTS, including those receiving treatment (see the PriMUS study protocol 15 for full inclusion and exclusion criteria). PriMUS participants receive a series of index tests and invasive urodynamics, conducted in primary care settings by trained research nurses.…”

Conducting invasive urodynamics in primary care: qualitative interview study examining experiences of patients and healthcare professionals

“…This qualitative study was part of the larger PriMUS study, which gained ethical approval from Wales Research Ethics Committee 6. PriMUS is recruiting adult men presenting to their GP with one or more bothersome LUTS, in approximately 90 GP practices across Newcastle upon Tyne, South Wales and Bristol (see study protocol [ 7 ] for full inclusion and exclusion criteria). Participants to date underwent a series of index tests together with invasive urodynamics, which is usually carried out in secondary care by specialist practitioners.…”

“…6 Northern Medical Physics and Clinical Engineering, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary, Newcastle upon Tyne, UK. 7 North Bristol NHS Trust, Southmead Hospital, Southmead Road, Westbury-on-Trym, Bristol, UK. 8 Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.…”

“…Recognising this issue, the UK National Institute for Health Research (NIHR) released a Health Technology Assessment (HTA) commissioned call for the development of a clinical decision aid to help inform treatment choice or need for specialist referral for men presenting with LUTS in primary care. The PriMUS study (‘Primary care management of lower urinary tract symptoms in men: development and validation of a diagnostic and clinical decision support tool’) addresses this brief [ 7 ]. PriMUS is a prospective diagnostic accuracy study based in UK primary care settings.…”