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Uva-ursi extract and ibuprofen as alternative treatments of adult female urinary tract infection (ATAFUTI): study protocol for a randomised controlled trial.

  • 2017-09-08
  • Trials 18(1)
    • Jeanne Trill
    • Catherine Simpson
    • Frances Webley
    • Mike Radford
    • Louise Stanton
    • Tom Maishman
    • Angeliki Galanopoulou
    • Andrew Flower
    • Caroline Eyles
    • Merlin Willcox
    • Alastair Hay
    • Gareth Griffiths
    • Paul Little
    • George Lewith
    • Michael Moore

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 328
Population
adult women with suspected UTI
Methods
randomised using a factorial trial design, Uva-ursi or placebo, with or without advice to take ibuprofen
Blinding
Double-blind
  • Large Human Trial

Background

Women with acute uncomplicated urine infection are usually treated with antibiotics. One trial has demonstrated that delayed antibiotic treatment offered without symptom relief results in a modest reduction in antibiotic use. There is some evidence that ibuprofen provides symptom relief and reduces antibiotic use. Uva-ursi, a herbal product, has a traditional use for urinary infection symptom relief. We set out to test: in adult women with suspected UTI who accept the delayed prescription strategy: Do NSAIDs or uva-ursi (a herbal product) provide relief from urinary symptoms and reduce antibiotic use.

Methods/design

Adult women with suspected urinary tract infection presenting to primary care will be randomised using a factorial trial design in which patients will be randomised to one of two interventions as below: Group 1 - Uva-ursi + advice to take ibuprofen Group 2 - Placebo + advice to take ibuprofen Group 3 - Uva-ursi + no advice to take ibuprofen Group 4 - Placebo + no advice to take ibuprofen Patients and physicians will be blinded to the randomised group for the herb. The main outcome is symptom severity at days 2-4 recorded in a validated, self-report diary used in previous studies. Secondary outcomes include antibiotic use and symptom duration. In total the trial will require 328 patients in order to achieve at least 90% power for the primary endpoint and 80% for the secondary endpoint. In accordance with CONSORT guidelines all comparative analyses will be conducted on an intention-to-treat basis using SPSS or similar package.

Discussion

The outcomes from this trial have the potential to modify the current approach to the management of acute urinary symptoms with less dependence on the use of antibiotics.

Trial registration

ISRCTN registry, ID: ISRCTN43397016 . Registered on 11 February 2015.

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