Are antibiotics really necessary to treat urinary tract infections in women or can support be offered with pain relief?

Phase 3

Completed

• Conditions: ncomplicated urinary tract infection; Urological and Genital Diseases; Uncomplicated urinary tract infection

• Registration Number: ISRCTN88111427
• Lead Sponsor: ational University of Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-17
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 460

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.