Study title
Primary care management of lower urinary tract symptoms in men: development and validation of a diagnostic and decision making aid (The PriMUS Study).
Principal / Lead Investigator
- Prof Adrian Edwards (PRIME, Cardiff University)
Co-Investigators
- Dr Natalie Joseph-Williams (PRIME, Cardiff University)
- Prof Kerry Hood (CTR / PRIME, Cardiff University)
- Dr Harry Ahmed (Cardiff University)
- Dr Emma Thomas-Jones (CTR, Cardiff University)
- Prof Robert Pickard
- Dr Alison Bray
- J Deeks
- J Rees
- Dr Joy Allen
- Mr Chris Harding
- Dr Michael Drinnan
- R Dixon
- Dr Yemisi Takwoingi
- Dr Tom Schatzberger
Trial Manager
Bethan Pell, Centre for Trials Research, Cardiff University
Type of study
Diagnostic accuracy study
Who is the study sponsor?
Cardiff University
Summary
Bothersome Lower Urinary Tract Symptoms (LUTS) can affect quality of life. These symptoms may include getting up at night frequently to pass urine, needing to go in a hurry, a poor stream, or sometimes incontinence. Men are often referred to urology specialists who often recommend treatments that could have been initiated in primary care if GPs had access to better diagnostic tools. Access to simple, accurate tests, diagnostic protocols and decision aids are needed to facilitate patient management in primary care.
Public / patient involvement
Robert Dixon (The Bladder and Bowel Foundation) acted as our patient and public representative during study development, and was also a co-applicant on the submitted bid. VOICENorth, a public participation group based in the North West of England, were also involved during the study development phase. A panel of male members were recruited to assess feasibility of the invasive erodynamic test that would be a requirement as part of study participation.
During the study period, members of the public / patients are involved in a number of ways. We are recruiting PPI members from across the 3 study sites (Newcastle, Birmingham, Cardiff), through known groups (e.g. Involving People), and some of these members will be part of the project management team.
The wider group will be consulted on a number of issues, including, but not restricted to, the design of patient facing documents and study recruitment strategies. Patient representatives will also form part of the Consensus Reference Group, which will reach agreement on the best ways to manage lower urinary tract symptoms in men.
How could this research potentially benefit patients?
The PriMUS study will develop a diagnostic aid based on symptoms, signs, patient characteristics and primary care based clinical tests that can indicate likely urodynamic diagnosis, which is the current ’gold standard’ test used to predict cause of LUTS in secondary care. This will help GPs to provide more accurate treatment and management decisions for LUTS.
Does the study involve commercial partnership activity?
No
Does the study involve a methodological innovation?
No
Funder
NIHR Health Technology Assessment (HTA) Programme
Total grant value
£1,555,527
Start date
01/05/2017
End date
30/04/2020
Further info (e.g. related web link)
- Project profile on Centre for Trials Research website: http://www.cardiff.ac.uk/centre-for-trials-research/research/studies-and-trials/view/primus
- Follow the PRIMUS project on twitter: https://twitter.com/ThePriMUSStudy
- PRIMUS study website: www.primus-study.co.uk
- Adrian Edwards interview for British Journal for General Practice (BJGP), 31 August 2021:
Outputs generated (Reports / Publications)
To follow
Impact
To follow