Primary Care Management of Lower Urinary Tract Symptoms in Men

Lower Urinary Tract Symptoms Clinical Trial

— PriMUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03520673
• Other study ID #: SPON 1553-16
• Secondary ID: 10327305
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: July 31, 2022

Study information

• Verified date: July 2021
• Source: Cardiff University
• Contact: Bethan Pell
• Phone: 02922510475
• Email: pellb[@]cardiff.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 880
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

Diagnostic Test:
• Urodynamics
All the men in the study will receive the urodynamics procedure as a reference test.

Locations

Country	Name	City	State
United Kingdom	Cardiff University	Cardiff

Sponsors (3)

Lead Sponsor	Collaborator
Cardiff University	Newcastle-upon-Tyne Hospitals NHS Trust, University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	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