Uncomplicated urinary tract infection Urological and Genital Diseases Uncomplicated urinary tract infection
Conditions
Interventions
Participants will receive either immediate treatment with nitrofurantoin 50mg, four times daily, or initial symptomatic treatment with ibuprofen 400mg, four times daily for three days. The original ta
Sponsors
National University of Ireland
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. GP- diagnosed urinary tract infection and at least one of the symptoms dysuria, urinary frequency, or urgency with/without low abdominal pain 2. Female 3. Aged 18 years or above 4. Able and willing to give written informed consent and to comply with the requirements of this study protocol 5. Smartphone ownership
Exclusion criteria
Exclusion criteria: 1. Any sign of a complicated infection, such as loin pain, fever, rigors, malaise, or vomiting 2. Pregnancy/breastfeeding child 3. Non-use of a highly effective contraceptive measure if the woman is considered of childbearing potential (WOCBP). Contraception methods with low user dependency should be used. 4. Diabetes mellitus 5. Chronic kidney disease (CKD) defined as estimated Glomerular Filtration Rate (eGFR) <60ml/min/1.73m2 or acute kidney injury, defined as any previously documented eGFR <60ml/min/1.73m2 6. Disease, anatomical abnormality or previous surgery of kidney or urinary tract 7. One or more urinary tract infections within the last four weeks 8. Permanent bladder catheter or use of bladder catheter within the last four weeks 9. Use of antibiotics within the last two weeks 10. Use of other investigational drugs within the last 30 days prior to screening 11. Concomitant use of NSAIDs and aspirin 12. Previous pyelonephritis 13. Acute porphyria Previous adverse reaction or hypersensitivity to ibuprofen, or worsening of asthma when using non-steroidal anti-inflammatory drugs 14. Previous adverse reaction to nitrofurantoin or other nitrofurans or fosfomycin 15. Current use of proton-pump inhibitor or H2 receptor blocker 16. Previous upper gastrointestinal bleed or perforation 17. Glucose 6 Phosphate Dehydrogenase deficiency 18. Severe heart failure (NYHA Class IV) or hepatic failure 19. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 20. Known allergy to azo colouring agents 21. Inability to follow instructions or comply with follow-up procedures 22. Any other medical condition(s) that may put the participant at risk or influence the study results in the investigator’s opinion or the investigator deems unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recovery with recovery, defined as a total score of <=1 across the symptoms dysuria, frequency, and urgency, as measured by a smartphone UTI diary app twice daily. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of participants recovered on day 4, with recovery defined as a total score of <=1 across the symptoms dysuria, frequency and urgency, each rated on a 0-4 scale 2. The proportion of participants with symptom resolution on day 4, with resolution defined as a total score = 0 across the symptoms dysuria, frequency and urgency, each rated on a 0-4 scale 3. The proportion of participants who received the back-up antibiotics (change during their treatment or requested at the end of treatment) is assessed recorded on their clinical notes (Ecrf) at the time of an unplanned visit due to worsening of symptoms 4. The proportion of participants who received an antibiotic prescription in the 28 days after the initial consultation is measured during their day 28 follow up call by the research nurse 5. Symptom load during days 0-7 is measured by comparing areas under the curve over the first 7 days 6. Proportion of participants with UTI recurrences in the 28 days after the initial consultation is measured by during their day 28 follow up call by the research nurse 7. Symptom burden of individual symptoms (dysuria, urinary frequency and urgency) from day 0-7 comparing daily scores for each symptom between groups 8. Activity Impairment Assessment (AIA) day 0 and 5, analysed by comparison of the time to resume normal daily activities 9. Proportion of participants with adverse events in the 28 days after the initial consultation | — |
Countries
Ireland
Contacts
Public ContactAkke Vellinga
Outcome results
None listed