Urinary tract infection Urological and Genital Diseases
Conditions
Interventions
Electronic randomisation using REDCap electronic database in a 1:1:1 ratio into one of three treatment groups:
Arm 1 - Immediate prescription of first line recommended antibiotics alon
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Potential participant is willing and able to give informed consent for participation in the study 2. Female aged 18 years or above CUTI Trial only: 1. Potential participant is making contact with general practice/primary care provider with urinary symptoms suggestive of acute, uncomplicated lower urinary tract infection (namely dysuria, urgency, frequency, polyuria/nocturia, haematuria and/or suprapubic pain), which the GP would normally treat with an immediate prescription of antibiotics 2. Symptom duration of under seven days (i.e. 6 days or less) 3. Potential participant is willing to receive either an immediate or delayed antibiotic prescription CUTI Interviews only: 1. Has experienced one or more UTIs in the past 12 months
Exclusion criteria
Exclusion criteria: CUTI Trial only: The potential participant may not enter the study if ANY of the following apply: 1. Has taken antibiotics within the past 7 days 2. Cranberry allergy 3. Already taking cranberry products regularly 4. Known or suspected pregnancy 5. Breastfeeding 6. Warfarin user (cranberries may interact with Warfarin) 7. Unable to get a clean-catch/midstream urine sample 8. In-dwelling catheter 9. Receiving end of life care/palliative care 10. Known underlying structural urological abnormalities (including polycystic kidneys) 11. Previous urological surgery 12. Immunosuppressed [e.g. active cancer (excluding localised skin cancer), receiving chemotherapy, taking regular high dose oral steroids (> 5mg/day) , HIV infection] 13. Diabetes mellitus treated with insulin 14. Signs of clinically suspected upper UTI/pyelonephritis 15. Inability to complete symptom diary accurately (e.g. dementia or psychosis) 16. Is currently involved in an interventional research study on UTI 17. Unable to access internet/email over the next two weeks 18. Is unable to decide on the same day that they contacted a primary care provider whether they would like to participate CUTI Interviews only: 1. Potential participant was immunosuppressed at the time of their UTI (including active cancer, receiving chemotherapy, diabetes mellitus treated with insulin or taking regular high-dose oral steroids (> 5 mg/day) 2. Potential participant has underlying urological abnormalities or has had previous urological surgery 3. Potential participant is receiving end of life care or palliative care 4. Potential participant declined to participate in the CUTI trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Quality and completeness of data obtained through participant completed diaries assessed through audit of proportion of diaries returned and completed by the end of participant follow up. 2. Rate of participant recruitment and number of participants lost to follow up through collation of results at the end of the study period. 3. Estimate of proportion of invited GPs and eligible potential participants agreeing to participate in the trial. At the end of the study, the trialists will review the proportion of GPs approached who agree to participate. They will also review screening and enrolment logs at the end of the study to determine the proportion of eligible potential participants that participate in the study. 4. Acceptability of study to participants, including assessment of face validity and acceptability of a 50-point Likert scale to be used in the participant symptom diary. This will be assessed though review of participant responses to questions in their completed symptom diaries at the end of participant follow up. Furthermore, interviews will take place with some trial participants at least one month after they were recruited into the trial. 5. Participants’ experiences of UTIs, views on self-care and self-help for UTIs and experiences of (if applicable) and thoughts on the CUTI trial will be assessed through interviews with some participants of the CUTI trial, as well as some women who were not part of the CUTI trial but have recent experience of a UTI (added 21/09/2020) 6. Acceptability of the study to recruiters through interviews with recruiters to the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/09/2020: Assessed using patient records at the end of the study period: 1.Proportion of participants consuming a course (or part thereof) of antibiotics in intervention and control groups 2. Number of antibiotic courses (or part thereof) consumed by participants in each group 3. Duration of symptoms rated moderately bad or worse in treatment and control groups 4. Symptom burden in treatment and control groups 5. Proportion of participants experiencing one or more adverse events, serious adverse events, requiring additional input from a healthcare practitioner, or taking time off usual/paid activities in each arm of the trial 6. Proportion of participants randomised to receive antibiotics only that consume cranberry products 7. Proportion of participants using additional treatments for their symptoms in each group 8. Comparison of time to feeling fully recovered between groups Previous secondary outcome measures: At the end of the study period, there will be preliminary statistical assessment of: 1. The number of participants consuming a course (or part thereof) of antibiotics 2. The duration of acute urinary tract symptoms rated moderately bad or worse 3. Any harms related to cranberry extract consumption. Assessment of harms will also take place through review of participant electronic medical records up to one month post randomisation to determine whether any adverse events occurred, and through interviews with some participants of the CUTI trial | — |
Countries
United Kingdom
Outcome results
None listed