Alternative treatments of adult female urinary tract infectio

Phase 3

Completed

• Conditions: Topic: Primary Care; Subtopic: Infectious diseases and microbiology, Primary care; Disease: All Diseases; Infections and Infestations

• Registration Number: ISRCTN43397016
• Lead Sponsor: niversity of Southampton

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28886751 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30685500

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-11
• Study Completion: 2017-05-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 376

Inclusion Criteria

1. Adult women (18-70) presenting to primary care with suspected lower urinary tract infection i.e. with at least one of dysuria, urgency or frequency
2. Patient able to provide informed written consent
3. Women willing to accept a delayed prescription for antibiotics

Exclusion Criteria

Current exclusion criteria as of 13/09/2016:
1. Known or suspected pregnancy or breast feeding. In women of child bearing age a urine pregnancy test will usually be performed unless not indicated (for instance prior hysterectomy)
2. Known immunodeficiency state, long term corticosteroids therapy or chemotherapy
3. Diabetes
4. Has any of the following known contraindications or cautions to Ibuprofen and any as listed in the current SmPC:
4.1. Asthmatics sensitive to NSAIDS/Ibuprofen or Aspirin
4.2. Severe heart failure and uncontrolled hypertension
4.3. Active gastrointestinal ulceration or bleeding
4.4. Crohn’s disease or ulcerative colitis
4.5. Documented poor renal function
4.6. Chronic Kidney disease (Grade 3-5)
5. Currently or within 7 days taken antibiotics
6. Using a NSAID or Uva Ursi preparation and unwilling to discontinue for the study period
7. Suspected upper urinary tract infection (back pain, high fever>38C, systemic illness)
8. Women whom immediate antibiotics are otherwise indicated frequent recurrent infection: >3 UTI episodes in past 12 months
9. Defect of the blood clotting system
10. Bladder surgery including cystoscopy in the last four weeks
11. Currently taking Warfarin
12. Recruited to another interventional trial in previous 6 weeks

Previous exclusion criteria:
1. Known or suspected pregnancy or breast feeding. In women of child bearing age a urine pregnancy test will usually be performed unless not indicated (for instance prior hysterectomy)
2. Known immunodeficiency state, long term corticosteroids therapy or chemotherapy
3. Diabetes
4. Has any of the following known contraindications or cautions to Ibuprofen and any as listed in the current SmPC:
4.1. Asthmatics sensitive to NSAIDS/Ibuprofen or Aspirin
4.2. Severe heart failure and uncontrolled hypertension
4.3. Active gastrointestinal ulceration or bleeding
4.4. Crohn’s disease or ulcerative colitis
4.5. Documented poor renal function
4.6. Chronic Kidney disease
5. Currently or within 7 days taken antibiotics
6. Using a NSAID or Uva Ursi preparation and unwilling to discontinue for the study period
7. Suspected upper urinary tract infection (back pain, high fever>38C, systemic illness)
8. Women whom immediate antibiotics are otherwise indicated frequent recurrent infection: >3 UTI episodes in past 12 months
9. Defect of the blood clotting system
10. Bladder surgery including cystoscopy in the last four weeks.
11. Currently taking Warfarin
12. Recruited to another trial in previous 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom severity day 2-4 using validated diary data