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

Trials. 2017 Sep 8;18(1):421. doi: 10.1186/s13063-017-2145-7.


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.

Keywords: Antibiotic resistance; Ibuprofen; NSAID; Urinary tract infection; Uva-ursi.

Publication types

  • Comparative Study
  • Multicenter Study
  • Pragmatic Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Arctostaphylos / chemistry
  • Clinical Protocols
  • Cystitis / diagnosis
  • Cystitis / drug therapy*
  • Cystitis / microbiology
  • Double-Blind Method
  • Female
  • Humans
  • Ibuprofen / adverse effects
  • Ibuprofen / therapeutic use*
  • Intention to Treat Analysis
  • Middle Aged
  • Plant Extracts / adverse effects
  • Plant Extracts / isolation & purification
  • Plant Extracts / therapeutic use*
  • Primary Health Care
  • Research Design
  • Time Factors
  • Treatment Outcome
  • United Kingdom
  • Urinary Tract Infections / diagnosis
  • Urinary Tract Infections / drug therapy*
  • Urinary Tract Infections / microbiology
  • Young Adult


  • Anti-Bacterial Agents
  • Anti-Inflammatory Agents, Non-Steroidal
  • Plant Extracts
  • Ibuprofen

Associated data

  • ISRCTN/ISRCTN43397016