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Alternative treatments of adult female urinary tract infection: a double blind, placebo controlled, factorial randomised trial

This study will evaluate two potential candidates for the treatment female Urinary Tract Infections (UTI): Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) and Uva Ursi, a herbal product with traditional use in UTI. It will also evaluate if this resulted in reduced antibiotic use.

Primary Objective: To evaluate whether Uva ursi compared to placebo or the advice to take ibuprofen compared to no advice provide relief from urinary symptoms in adult women with suspected UTI.

Secondary Objectives: 

  1. To evaluate whether Uva Ursi compared to placebo or the advice to take ibuprofen compared to no advice result in reduced antibiotic use in adult women with suspected UTI.
  2. 2. To determine the patient / practitioner barriers to implementation of a delayed antibiotic prescription approach and use of herbal medication.

Background

Urinary tract infections (UTIs) are one of the most common conditions seen in female patients in general practice and one of the most common conditions treated with antibiotics in primary care. It is a national priority to reduce antibiotic prescribing where possible and resistance to antibiotics is a particular problem with UTI in adult women. In UTI delayed prescribing is acceptable for women and it is considered to be a more effective way to modify consultation behaviour than patient education. Delayed prescribing in UTI is unlikely to be widely adopted without an alternative treatment to provide substantial relief from the symptoms of infection. If an effective symptom reliever were identified then this would be likely to both encourage the adoption of the delayed strategy and further reduce antibiotic use in UTI.

Study Design: Four parallel group factorial design, randomised double blind placebo controlled trial.
Sponsor: University of Southampton
Ethical Approval:  EudraCT reference no: 2013-003327-1
Chief Investigator: Dr Michael Moore (University of Southampton) 
Contact Details: nicola.blakey@phc.ox.ac.uk

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