Primary Care Management of Lower Urinary Tract Symptoms in Men

NCT03520673 | Completed

• 2 other identifiers: SPON 1553-1610327305
• Study Type: interventional
• Target: 725
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

Lower Urinary Tract Symptoms; Primary Care; Urology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Secondary Outcome 1 - Construction of a patient management algorithm to guide initial treatment for men with LUTS

  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

  24 months

• Secondary Outcome 3 - Estimate potential percentage change in referral rates to secondary care for men with LUTS

  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

  36 months

Study Arms (1)

Development of Clinical Decision Support Tool

OTHER

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

Interventions

Urodynamics DIAGNOSTIC_TEST

All the men in the study will receive the urodynamics procedure as a reference test.

Development of Clinical Decision Support Tool

Eligibility Criteria

• Age: 16 Years+
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiff University: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator
• University of Birmingham: collaborator

Study Sites (1)

Cardiff University

Cardiff, CF14 4YS, United Kingdom

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Urodynamics

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Adrian Edwards Profressor

  Division of Population Medicine, Cardiff University

  PRINCIPAL INVESTIGATOR

• Chris Harding Mr

  Newcastle Upon Tyne NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diagnostic Accuracy Study

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: May 11, 2018
• Study Start: May 1, 2017
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)