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Clinical Trials/ISRCTN43397016
ISRCTN43397016CompletedPhase 3

Alternative Treatments of Adult Female Urinary Tract Infection: a double-blind, placebo-controlled, factorial randomised trial of Uva ursi and open pragmatic trial of ibuprofen

niversity of Southampton0 sites376 target enrollmentStarted: February 11, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
376
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
Female

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.

Investigators

Sponsor
niversity of Southampton

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