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General practice / Family practice
Protocol
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)
  1. Bethan Pell1,
  2. Emma Thomas-Jones1,
  3. Alison Bray2,3,
  4. Ridhi Agarwal4,
  5. Haroon Ahmed5,
  6. A Joy Allen6,
  7. Samantha Clarke7,
  8. Jonathan J Deeks8,
  9. Marcus Drake7,
  10. Michael Drinnan2,3,
  11. Calie Dyer1,
  12. Kerenza Hood1,
  13. Natalie Joseph-Williams5,
  14. Lucy Marsh1,
  15. Sarah Milosevic1,
  16. Robert Pickard9,
  17. Tom Schatzberger10,
  18. Yemisi Takwoingi4,
  19. Chris Harding9,
  20. Adrian Edwards5
  1. 1Centre for Trials Research, Cardiff University, Cardiff, UK
  2. 2Medical Physics, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
  3. 3Translational and Clinical Research Institute, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
  4. 4Test Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
  5. 5Division of Population Medicine, Cardiff University, Cardiff, South Glamorgan, UK
  6. 6NIHR In Vitro Diagnostics Co-operative, Newcastle University, Newcastle upon Tyne, UK
  7. 7North Bristol NHS Trust, Westbury on Trym, Bristol, UK
  8. 8Public Health, Epidemiology and Biostatistics, University of Birmingham, Birmingham, UK
  9. 9Department of Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
  10. 10Corbridge Health Centre, NHS Northumberland Clinical Commissioning Group, Newcastle, Northumberland, UK
  1. Correspondence to Bethan Pell; pellb{at}cardiff.ac.uk

Abstract

Introduction Lower 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 analysis PRImary 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 dissemination Ethics 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 number ISRCTN10327305.

  • primary care
  • urology
  • adult urology
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2020-037634

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    Footnotes

    • Twitter @harryahmed01, @SamClarkeRN

    • Contributors AE and CH are co-chief investigators of this study. AE and CH, along with HA, AJA, AB, MaD, JJD, MiD, KH, NJ-W, RP, TS, YT and ET-J, led the development of the research question, study design, obtaining the funding and implementation of the study protocol. BP is the study manager and ET-J is the senior study manager who coordinated the operational delivery of the study protocol and recruitment. SC provides research nurse insight and support. NJ-W and SM are the qualitative researchers. YT and RA are the study statisticians. CD and LM are the data managers. All authors listed provided critical review and final approval of the manuscript.

    • Funding This study is funded by the NIHR (Health Technology Assessment programme), funder reference 15-40-05. Cardiff University, Research and Innovation Services Department, Contracts Team, Cardiff University, 30-36 Newport Road, Cardiff, CF24 0DE. Contact person: Ms Helen Falconer; FalconerHE@cardiff.ac.uk. Sponsor reference: SPON 1553-16.

    • Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Neither the Sponsor nor the Funder had any role on the study design; collection, management, analysis and interpretation of data; writing of this manuscript or in the decision to submit this manuscript for publication.

    • Competing interests One of the index tests, Flowtaker, was developed by a team from Newcastle upon Tyne Hospitals (NuTH) and Newcastle University, including two individuals who are grant co-applicants, members of the study management team and co-authors (AB and MiD). In 2014, the device was licensed to MMS (Enschede, the Netherlands) and royalties from the sale of the device were paid to NuTH (not to the individuals). MMS was subsequently acquired by Laborie who removed Flowtaker from the market in January 2018.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.