Trial Name

ATAFUTI - 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.

Description

A Phase III trial investigating alternative treatments for adult female urinary tract infection.

Objectives

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:

• 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.
• To determine the patient / practitioner barriers to implementation of a delayed antibiotic prescription approach and use of herbal medication.
  

Design

Multicentre, factorial (2 x 2), randomised double blind placebo controlled trial of Uva ursi and open trial of ibuprofen advice.

Participants will be randomised to one of four groups:

• Group 1: Uva ursi + Advice to take ibuprofen
• Group 2: Uva ursi placebo + Advice to take ibuprofen
• Group 3: Uva ursi + No advice to take ibuprofen
• Group 4: Uva ursi placebo + No advice to take ibuprofen

All participants will be issued a prescription for delayed antibiotics. This prescription will be used if symptoms worsen or after three to five days if symptoms are not improving (most symptoms should have settled by this time).

Participants will take the study medication for three days or up to five days and will complete a symptom diary for up to two weeks. A notes review will be undertaken at three months.

A sample of participants will be invited to take part in qualitative interviews to find out about their views on antibiotics and alternative treatments for UTIs.

A sample of GPs from participating surgeries will also have qualitative interviews to elicit attitudes towards alternative treatments.

Status

Complete

Population

376 Adult women (18-70) presenting to primary care, with suspected lower urinary tract infection (suspected by GP or nurse practitioner)

Publications

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

Final Paper: Uva-ursi extract and ibuprofen as alternative treatments for uncomplicated urinary tract infection in women (ATAFUTI): a factorial randomized trial

Contact details

All Trial enquiries should be addressed to ctu@soton.ac.uk