Lower Urinary Tract SymptomsPriMUSNCT03520673
Primary Care Management of Lower Urinary Tract Symptoms in Men
A study testing Urodynamics in people with Lower Urinary Tract Symptoms, run by Cardiff University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Urodynamics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 725 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2017to 14 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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*
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Care Management of Lower Urinary Tract Symptoms in Men: Development and Validation of a Diagnostic and Clinical Decision Support Tool
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.
Read the 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
- Being tested
- Urodynamics
- Keywords
- Lower Urinary Tract Symptoms, Primary Care, Urology
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrodynamicsDiagnostic test
All the men in the study will receive the urodynamics procedure as a reference test.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Urodynamics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 24 months
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.
Measured: 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
Estimation of potential costs / savings of implementation of the primary care LUTS decision aid both from a population and individual patient perspective
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 May 2017
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Diagnostic Accuracy Study
- Masking
- None (open label)
- Enrolment
- 725 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, University of Birmingham
- Responsible party
- Sponsor
- Investigators
- Adrian Edwards Profressor, Principal investigator, Division of Population Medicine, Cardiff UniversityChris Harding Mr, Principal investigator, Newcastle Upon Tyne NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520673
- Sponsor's protocol ID
- SPON 1553-16
- Other IDs
- 10327305
- Acronym
- PriMUS
- Status last verified
- May 2025
- First submitted
- 23 Mar 2018
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Management of Lower Urinary Tract Symptoms in Men: Development and Validation of a Diagnostic and Clinical Decision Support Tool
- ClinicalTrials.gov ID
- NCT03520673
- Acronym / sponsor ID
- PriMUS / SPON 1553-16
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lower Urinary Tract Symptoms, Primary Care, Urology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 725 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, University of Birmingham
- Study start
- 1 May 2017 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Diagnostic Accuracy Study
| Arm | Type | Receives |
|---|---|---|
| Development of Clinical Decision Support Tool | Other | Diagnostic Test: UrodynamicsAll 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UrodynamicsAll the men in the study will receive the urodynamics procedure as a reference test. | Diagnostic test | Development of Clinical Decision Support Tool |
Primary outcome
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.
Time frame: 36 months
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.
4 secondary outcomes
Secondary Outcome 1 - Construction of a patient management algorithm to guide initial treatment for men with LUTS
Time frame: 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
Time frame: 24 months
Secondary Outcome 3 - Estimate potential percentage change in referral rates to secondary care for men with LUTS
Time frame: 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
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
Related trials for Lower Urinary Tract Symptoms
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Edwards Profressor principal investigator
Division of Population Medicine, Cardiff University
Chris Harding Mr principal investigator
Newcastle Upon Tyne NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urodynamics in people with Lower Urinary Tract Symptoms, run by Cardiff University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.