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

Primary Purpose

Lower Urinary Tract Symptoms

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Urodynamics

About this trial

This is an interventional diagnostic trial for Lower Urinary Tract Symptoms focused on measuring Lower Urinary Tract Symptoms, Primary Care, Urology

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Cardiff UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Development of Clinical Decision Support Tool

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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

Full Information

NCT ID

NCT03520673

First Posted

March 23, 2018

Last Updated

August 10, 2021

Sponsor

Cardiff University

Collaborators

Newcastle-upon-Tyne Hospitals NHS Trust, University of Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT03520673

Brief Title

Primary Care Management of Lower Urinary Tract Symptoms in Men

Acronym

PriMUS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cardiff University

Collaborators

Newcastle-upon-Tyne Hospitals NHS Trust, University of Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lower Urinary Tract Symptoms

Keywords

Lower Urinary Tract Symptoms, Primary Care, Urology

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Diagnostic Accuracy Study

Masking

None (Open Label)

Allocation

N/A

Enrollment

880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Development of Clinical Decision Support Tool

Arm Type

Other

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Urodynamics

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

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.

Time Frame

36 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

36 months

Title

Secondary Outcome 2 - Qualitative analysis of patients' and clinicians' views on the use of a LUTS decision aid in the primary care setting

Description

Analyse the acceptability of a decision aid in primary care with patients and clinicians, to assess the decision tool's value and potential usability.

Time Frame

24 months

Title

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

Description

To calculate the potential change in referral rates of men with LUTs into secondary care to calculate the potential overall excess treatment cost savings.

Time Frame

36 months

Title

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

Description

Estimation of potential costs / savings of implementation of the primary care LUTS decision aid both from a population and individual patient perspective

Time Frame

36 months

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bethan Pell

Phone

02922510475

pellb@cardiff.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Emma Thomas-Jones

thomas-jonese@cardiff.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrian Edwards Profressor

Organizational Affiliation

Division of Population Medicine, Cardiff University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chris Harding Mr

Organizational Affiliation

Newcastle Upon Tyne NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cardiff University

City

Cardiff

ZIP/Postal Code

CF14 4YS

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Janine Bates

BatesMJ@cardiff.ac.uk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Primary Care Management of Lower Urinary Tract Symptoms in Men

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