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.
Highlights
Lower urinary tract symptoms (LUTS) is a bothersome condition affecting older men which can lead to poor quality of life
Invasive urodynamics will be conducted rather than video urodynamics, which is in line with most contemporary national and international guidelines, and is sufficient to diagnose DO, bladder outlet obstruction (BOO) and DU, to which most non-complicated adult male LUTS can be attributed
Our team was successful in obtaining this funding and here we describe the protocol for our study: ‘Primary care management of lower urinary tract symptoms in men: Development and validation of a diagnostic and clinical decision support tool’ (the PRImary care Management of lower Urinary tract Symptoms (PriMUS) study)
Summary
Lower urinary tract symptoms (LUTS), such as frequent urination, a slow stream, and having to wake in the night to urinate, affect a significant proportion of older men and can Strengths and limitations of this study. Objectives and outcome measures The PriMUS study aims to develop three diagnostic prediction models based on the results of simple clinical tests that can provide a useful prediction of urodynamic observations in men with LUTS. We will assess the diagnostic accuracy of these models, which will be implemented in software, along with management recommendation algorithms to form a clinical decision support tool for use in UK primary care. Primary objectives ►► Develop a statistical model to predict the likelihood of three urological conditions (BOO, DO and DU) based on a series of non-invasive index tests, with invasive urodynamics as the reference standard. Secondary outcomes ►► A patient management algorithm to guide initial treatment for men with LUTS. ►► A prototype online clinical decision support tool for use in primary care. ►► Qualitative summary of patients’ and clinicians’ views on the use of a LUTS clinical decision support tool in the primary care setting. ►► Costs/savings of implementation of the primary care LUTS clinical decision support tool both from a population and individual patient perspective
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