NCT03520673

Primary Care Management of Lower Urinary Tract Symptoms in Men

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 725 (actual)
• Sponsor: Cardiff University · Academic / Other
• Sex: Male
• Age: 16 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Urodynamics	All the men in the study will receive the urodynamics procedure as a reference test.

Timeline

• Start date: 2017-05-01
• Primary completion: 2022-11-14
• Completion: 2022-11-14
• First posted: 2018-05-11
• Last updated: 2025-05-15

Locations

1 site across 1 country: United Kingdom