Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03520673
Study type Interventional
Source Cardiff University
Contact Bethan Pell
Phone 02922510475
Email pellb@cardiff.ac.uk
Status Recruiting
Phase N/A
Start date May 1, 2017
Completion date July 31, 2022

See also
  Status Clinical Trial Phase
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Enrolling by invitation NCT06317116 - Examining the Relationship Between Core Muscles and Bladder Issues in Children
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Recruiting NCT05814614 - Bladder Complaints in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation N/A
Recruiting NCT04288427 - 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy N/A
Not yet recruiting NCT06452927 - EEP in Patients With Urodynamically Proven DU/DA N/A
Completed NCT02330107 - Auriculotherapy on Lower Urinary Tract Symptoms in Elderly Men N/A
Completed NCT03339609 - Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children N/A
Terminated NCT02003742 - Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH Phase 3
Terminated NCT01003249 - Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen Phase 4
Completed NCT01078545 - Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS) N/A
Completed NCT02074644 - Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic Hyperplasia N/A
Recruiting NCT03802851 - HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer N/A
Active, not recruiting NCT05415748 - Deprescribing Tamsulosin in Older Men Phase 4
Recruiting NCT05702294 - Electronic Urinary Flowmeter to Improve Accuracy of Bladder Diaries . N/A
Enrolling by invitation NCT05537272 - The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy Phase 4
Recruiting NCT05826691 - Benign Prostate Surgery and QOL and Sexual Function
Completed NCT04104100 - Prevalence and Risk Factor of NP in Women With LUTS
Completed NCT04190641 - Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder N/A