Primary Care Management of Lower Urinary Tract Symptoms in Men (PriMUS)

Primary Care Management of Lower Urinary Tract Symptoms in Men: Development and Validation of a Diagnostic and Clinical Decision Support Tool

The PriMUS Study aims to develop a clinical decision support tool to help GPs more accurately diagnose and manage LUTS in men. The study will recruit 880 men across three research hubs in Bristol, Newcastle and Wales. Men will all receive a series of simple index tests in primary care (following NICE Clinical Guidelines) and a urodynamics reference test. The study will then compare which combination of the simple index tests give the best prediction of the urodynamics result, which can then be incorporated into the clinical decision support tool.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms
• Intervention / Treatment: Diagnostic test: Urodynamics

Detailed Description

Men are more likely to experience bothersome Lower Urinary Tract Symptoms (LUTS) as they get older. GPs follow standard processes to investigate signs of cancer, or more serious conditions but do not have access to tools to identify and manage more common symptoms of LUTS. This means men are likely to be referred to a urologist in secondary care, where they will receive advice or treatment that could have been given in primary care if GPs had more access to better diagnostic tools. The PriMUS Study will compare the results of the simple index tests, with the results of the urodynamic reference test, to identify which combination of simple index tests give the best prediction of the urodynamics diagnosis. The top performing simple index tests will be incorporated into the clinical decision support tool so that GPs can manage patients without needing invasive urodynamics. Follow up will be conducted 6 months post involvement; collating the treatment and management decisions made as a result of these procedures. The study will also consider and explore practicalities and acceptability of the urodynamic procedure and clinical decision support tool for both patients and clinical staff by conducting separate qualitative work.

• Study Type: Interventional
• Enrollment (Actual): 725
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF14 4YS
    • Cardiff University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men aged 16 years and over.
• Men who present to their GP with a complaint of one or more bothersome lower urinary tract symptoms (LUTS)#
• Men able and willing to give informed consent for participation in study

• Men able and willing to undergo all index tests and reference test, and complete study documentation.

  • This would include men on current treatment, but who are still symptomatic

Exclusion criteria

• Men with neurological disease or injury affecting lower urinary tract function
• Men with LUTS considered secondary to current or past invasive treatment or radiotherapy for pelvic disease
• Men with other contraindications to urodynamics e.g. Heart valve or joint replacement surgery within the last 3 months, immunocompromised/immunosuppressed.
• Men with indwelling urinary catheters or who carry out intermittent self-catheterisation

• Men whose initial assessment suggests that clinical findings are suggestive of possible:

  • prostate or bladder cancer*
  • recurrent or persistent symptomatic UTI**
  • retention e.g. palpable bladder after voiding'

• Men unable to consent in English or Welsh where a suitable translator is not available. This is a multi-centre study based in primary care, and we cannot guarantee translation facilities at all sites

  • According to standard NHS cancer pathways. If later deemed unlikely, then eligible for study participation.

    • If UTI successfully treated but LUTS remain, then eligible for study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Development of Clinical Decision Support Tool; All men will receive the same series of simple index tests which will be compared with the results of the urodynamics reference test to identify which index tests give the best prediction of the urodynamic results. The data from the first cohort will develop the clinical decision support tool.	Diagnostic test: Urodynamics; All the men in the study will receive the urodynamics procedure as a reference test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome 1- Sensitivity and specificity of the PriMUS clinical decision aid in diagnosing detrusor underactivity, bladder outlet obstruction and detrusor over activity, in men with lower urinary tract symptoms presenting to primary care.	The accuracy of a clinical decision tool, which incorporates simple index tests, by reference and comparison to Urodynamic investigation as the gold standard at 36 months.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome 1 - Construction of a patient management algorithm to guide initial treatment for men with LUTS	Identify which combination of simple tests (including e.g. ethnicity, smoking status, height (cm) and weight (kg), medical history, medication, outcome of bladder diary, self-reported symptoms scores using IPSS and ICIQ questionnaires, Digital Rectal Examination Result, Prostate Specific Antigen (PSA) result, Abdominal Physical Examination Result) best predict the urodynamic diagnosis at 36 months.	36 months
Secondary Outcome 2 - Qualitative analysis of patients' and clinicians' views on the use of a LUTS decision aid in the primary care setting	Analyse the acceptability of a decision aid in primary care with patients and clinicians, to assess the decision tool's value and potential usability.	24 months
Secondary Outcome 3 - Estimate potential percentage change in referral rates to secondary care for men with LUTS	To calculate the potential change in referral rates of men with LUTs into secondary care to calculate the potential overall excess treatment cost savings.	36 months
Secondary Outcome 4 - Estimation of potential costs / savings of implementation of the primary care LUTS decision aid both from a population and individual patient perspective	Estimation of potential costs / savings of implementation of the primary care LUTS decision aid both from a population and individual patient perspective	36 months

Collaborators and Investigators

• Sponsor: Cardiff University
• Collaborators: University of Birmingham; Newcastle-upon-Tyne Hospitals NHS Trust
• Investigators: Principal Investigator: Adrian Edwards Profressor, Division of Population Medicine, Cardiff University; Principal Investigator: Chris Harding Mr, Newcastle Upon Tyne NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): November 14, 2022
• Study Completion (Actual): November 14, 2022

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Primary Care; Lower Urinary Tract Symptoms; Urology
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: SPON 1553-16; 10327305 (Registry Identifier: ISRCTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No