Primary Care Management of Lower Urinary Tract Symptoms in Men

NCT ID: NCT03520673

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 725 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2022-11-14

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Urodynamics

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Urodynamics

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

University of Birmingham

OTHER

Sponsor Role: collaborator

Cardiff University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Edwards Profressor

Role: PRINCIPAL_INVESTIGATOR

Division of Population Medicine, Cardiff University

Chris Harding Mr

Role: PRINCIPAL_INVESTIGATOR

Newcastle Upon Tyne NHS Foundation Trust

Locations

Cardiff University

Cardiff, , United Kingdom

Countries

United Kingdom

Other Identifiers

10327305

Identifier Type: REGISTRY

Identifier Source: secondary_id

SPON 1553-16

Identifier Type: -

Identifier Source: org_study_id