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
Co-Investigators
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

Outputs generated (Reports / Publications)

To follow

Impact

To follow