Primary Care Management of Lower Urinary Tract Symptoms in Men (PriMUS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03520673|
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lower Urinary Tract Symptoms||Diagnostic Test: Urodynamics||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||880 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Diagnostic Accuracy Study|
|Masking:||None (Open Label)|
|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|
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 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 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.
- 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.
- 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.
- 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
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
|Contact: Bethan Pellfirstname.lastname@example.org|
|Contact: Emma Thomas-Jonesemail@example.com|
|Cardiff, United Kingdom, CF14 4YS|
|Contact: Bethan Pell firstname.lastname@example.org|
|Principal Investigator:||Adrian Edwards Profressor||Division of Population Medicine, Cardiff University|
|Principal Investigator:||Chris Harding Mr||Newcastle Upon Tyne NHS Foundation Trust|