Uva-ursi extract and ibuprofen as alternative treatments of adult female urinary tract infection (ATAFUTI): study protocol for a randomised controlled trial
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
Affiliations
Jeanne Trill
Primary Care and Population Science, University of Southampton Faculty of Medicine, Aldermoor Health Centre
Catherine Simpson
Southampton Clinical Trials Unit, University of Southampton Clinical Trials Unit MP131, Southampton General Hospital
Frances Webley
Southampton Clinical Trials Unit, University of Southampton Clinical Trials Unit MP131, Southampton General Hospital
Mike Radford
Southampton Clinical Trials Unit, University of Southampton Clinical Trials Unit MP131, Southampton General Hospital
Louise Stanton
Southampton Clinical Trials Unit, University of Southampton Clinical Trials Unit MP131, Southampton General Hospital
Tom Maishman
Southampton Clinical Trials Unit, University of Southampton Clinical Trials Unit MP131, Southampton General Hospital
Angeliki Galanopoulou
Southampton Clinical Trials Unit, University of Southampton Clinical Trials Unit MP131, Southampton General Hospital
Andrew Flower
Primary Care and Population Science, University of Southampton Faculty of Medicine, Aldermoor Health Centre
Caroline Eyles
Primary Care and Population Science, University of Southampton Faculty of Medicine, Aldermoor Health Centre
Merlin Willcox
Primary Care and Population Science, University of Southampton Faculty of Medicine, Aldermoor Health Centre
Alastair Hay
Centre for Academic Primary Care, National Institute for Health Research (NIHR) School for Primary Care Research, Population Health Sciences, Bristol Medical School, University of Bristol
Gareth Griffiths
Southampton Clinical Trials Unit, University of Southampton Clinical Trials Unit MP131, Southampton General Hospital
Paul Little
Primary Care and Population Science, University of Southampton Faculty of Medicine, Aldermoor Health Centre
George Lewith
Primary Care and Population Science, University of Southampton Faculty of Medicine, Aldermoor Health Centre
Michael Moore
Primary Care and Population Science, University of Southampton Faculty of Medicine, Aldermoor Health Centre
Abstract 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.
