Urinary tract infections Urological and Genital Diseases Urinary tract infection
Conditions
Interventions
Adult women aged 18 years and over presenting to UK general practice with symptoms attributable to urinary tract infection (UTI), including at least one of dysuria, haematuria or frequency of urinatio
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women =18 years of age presenting to UK General Practice with symptoms consistent with urinary tract infection.
Exclusion criteria
Exclusion criteria: The participant may not enter the study if ANY of the following apply: 1. Patients who are currently taking antibiotics or have taken antibiotics in the last 7 days 2. Patients with indwelling catheters or using intermittent self-catheterisation 3. Patients unable to give informed consent 4. Previously recruited to the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of contaminated urine specimens; measured as the proportion of samples in each arm reported as a mixed growth following NHS microbiology laboratory urine culture performed according to national standard operating procedures and reported within 7 days of sampling | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the impact of urine collection devices on: 1. Detection of urine infection using laboratory techniques, measured using the proportion of samples reported as a pure or predominant growth of a known urinary pathogen following urine culture performed according to national standard reporting procedures, and the presence and number of white cells on urine microscopy within 7 days of sampling. 2. The diagnostic accuracy of dipstick urinalysis performed at the time of sample provision for urine infection by reporting sensitivity and specificity of dipstick urinalysis for a pure growth of a known urinary pathogen on urine culture 3. Presence of cells in urine which are suggestive of contamination measured by the presence and number of epithelial cells on urine microscopy reported within 7 days of sampling Also to investigate: 4. The acceptability of three urine sampling methods to patients using qualitative interviews, which will be ongoing during the trial until saturation of themes is reached 5. The acceptability of three urine sampling methods to primary care professionals from qualitative thematic analysis of focus groups. Focus groups will be performed with primary care professionals at the end of the trial, once results are available for discussion 6. The cost effectiveness and impact on NHS resources measured by: 6.1.Cost per contaminated urine specimen avoided and Cost per QALY gained 6.2. Number of participants requiring one or more further urine culture tests within 14 days 7. Health care utilization and complications in patients using each device compared to standardised usual care measured by the number of participants requiring repeat consultation with the GP or hospital admission for symptoms or complications of UTI within 14 days 8. Morbidity of UTI in patients using a d | — |
Countries
United Kingdom
Contacts
Public ContactGail Hayward
Outcome results
None listed