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

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ClinicalTrials.gov Identifier: NCT03520673
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : May 10, 2018
Sponsor:
Collaborators:
Newcastle-upon-Tyne Hospitals NHS Trust
University of Birmingham
Information provided by (Responsible Party):
Cardiff University

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.

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Diagnostic Test: Urodynamics Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 880 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Diagnostic Accuracy Study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Primary Care Management of Lower Urinary Tract Symptoms in Men: Development and Validation of a Diagnostic and Clinical Decision Support Tool
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Diagnostic Test: Urodynamics
All the men in the study will receive the urodynamics procedure as a reference test.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Secondary Outcome 1 - Construction of a patient management algorithm to guide initial treatment for men with LUTS [ Time Frame: 36 months ]
    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.

  2. 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 ]
    Analyse the acceptability of a decision aid in primary care with patients and clinicians, to assess the decision tool's value and potential usability.

  3. Secondary Outcome 3 - Estimate potential percentage change in referral rates to secondary care for men with LUTS [ Time Frame: 36 months ]
    To calculate the potential change in referral rates of men with LUTs into secondary care to calculate the potential overall excess treatment cost savings.

  4. 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 ]
    Estimation of potential costs / savings of implementation of the primary care LUTS decision aid both from a population and individual patient perspective



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520673


Contacts
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Contact: Bethan Pell 02922510475 pellb@cardiff.ac.uk
Contact: Emma Thomas-Jones thomas-jonese@cardiff.ac.uk

Locations
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United Kingdom
Cardiff University Recruiting
Cardiff, United Kingdom, CF14 4YS
Contact: Bethan Pell       pellb@cardiff.ac.uk   
Sponsors and Collaborators
Cardiff University
Newcastle-upon-Tyne Hospitals NHS Trust
University of Birmingham
Investigators
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Principal Investigator: Adrian Edwards Profressor Division of Population Medicine, Cardiff University
Principal Investigator: Chris Harding Mr Newcastle Upon Tyne NHS Foundation Trust

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Responsible Party: Cardiff University
ClinicalTrials.gov Identifier: NCT03520673     History of Changes
Other Study ID Numbers: SPON 1553-16
10327305 ( Registry Identifier: ISRCTN )
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cardiff University:
Lower Urinary Tract Symptoms
Primary Care
Urology

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms