Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2017

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Am J Med. 2002;113(Suppl 1A):5S–13S.CrossRefPubMed
2.
Little P, Merriman R, Turner S, Rumsby K, Warner G, Lowes J, et al. Presentation, pattern, and natural course of severe symptoms, and role of antibiotics and antibiotic resistance among patients presenting with suspected uncomplicated urinary tract infection in primary care: observational study. BMJ. 2010;340:b5633.CrossRefPubMedPubMedCentral
3.
O’Brien K, Hillier S, Simpson S, Hood K, Butler C. An observational study of empirical antibiotics for adult women with uncomplicated UTI in general practice. J Antimicrob Chemother. 2007;59(6):1200–3.CrossRefPubMed
4.
Richards D, Toop L, Chambers S, Fletcher L. Response to antibiotics of women with symptoms of urinary tract infection but negative dipstick urine test results double blind randomised controlled trial. BMJ. 2005;331:143.CrossRefPubMedPubMedCentral
5.
Christiaens TC, De MM, Verschraegen G, Peersman W, Heytens S, De Maeseneer JM. Randomised controlled trial of nitrofurantoin versus placebo in the treatment of uncomplicated urinary tract infection in adult women. Br J Gen Pract. 2002;52(482):729–34.PubMedPubMedCentral
6.
Butler CC, Hillier S, Roberts Z, Dunstan F, Howard A, Palmer S. Antibiotic-resistant infections in primary care are symptomatic for longer and increase workload: outcomes for patients with E. coli UTIs. Br J Gen Pract. 2006;56(530):686–92.PubMedPubMedCentral
7.
Hillier S, Roberts Z, Dunstan F, Butler C, Howard A, Palmer S. Prior antibiotics and risk of antibiotic-resistant community-acquired urinary tract infection: a case-control study. J Antimicrob Chemother. 2007;60(1):92–9.CrossRefPubMed
8.
Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010;340:c2096.CrossRefPubMed
9.
Nickel JC, Lee JC, Grantmyre JE, Polygenis D. Natural history of urinary tract infection in a primary care environment in Canada. Can J Urol. 2005;12(4):2728–37.PubMed
10.
Foxman B. Urinary tract infection syndromes: occurrence, recurrence, bacteriology, risk factors, and disease burden. Infect Dis Clin North Am. 2014;28(1):1–13.CrossRefPubMed
11.
Falagas ME, Kotsantis IK, Vouloumanou EK, Rafailidis PI. Antibiotics versus placebo in the treatment of women with uncomplicated cystitis: a meta-analysis of randomized controlled trials. J Infect. 2009;58(2):91–102.CrossRefPubMed
12.
13.
NICE. Prescribing of antibiotics for self-limiting respiratory tract infections in adults and children in primary care. 2011.
14.
Thoolen B, de Ridder D, van Lensvelt-Mulders G. Patient-oriented interventions to improve antibiotic prescribing practices in respiratory tract infections: a meta-analysis. Health Psychol Rev. 2012;6(1):92–112.CrossRef
15.
Little P, Moore MV, Turner S, Rumsby K, Warner G, Lowes JA, et al. Effectiveness of five different approaches in management of urinary tract infection: randomised controlled trial. BMJ. 2010;340(feb05_1):c199.CrossRefPubMedPubMedCentral
16.
Bleidorm J, Gagyor I, Kochen M, Wegscheider K, Hummers-Pradie E. Symptomatic treatment (ibuprofen) or antibiotics (ciprofloxacin) for uncomplicated urinary tract infection?—Results of a randomized controlled pilot trial. BMC Med. 2010;8:30.CrossRef
17.
Gagyor I, Bleidorn J, Kochen MM, Schmiemann G, Wegscheider K, Hummers-Pradier E. Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial. BMJ. 2015;351:h6544.CrossRefPubMedPubMedCentral
18.
EMA European Medicines Agency. Assessment report on Arctostaphylos uva-ursi (l.) Spreng. folium. 2012.
19.
Larsson B, Jonasson A, Fianu S. Prophylactic effect of UVA-E in women with recurrent cystitis: a preliminary report. Curr Ther Res. 1993;53(4):441–3.CrossRef
20.
Little P, Turner S, Rumsby K, Warner G, Moore M, Lowes J, et al. Dipsticks and diagnostic algorithms in urinary tract infection: development and validation, randomised trial, economic analysis, observational cohort and qualitative study. Health Technol Assess. 2009;13(19):1–73.CrossRefPubMed
21.
Bates J, Thomas-Jones E, Pickles T, Kirby N, Gal M, Bongard E, et al. Point of care testing for urinary tract infection in primary care (POETIC): protocol for a randomised controlled trial of the clinical and cost effectiveness of FLEXICULT informed management of uncomplicated UTI in primary care. BMC Fam Pract. 2014;15:187.CrossRefPubMedPubMedCentral
22.
Watson L, Little P, Moore M, Warner G, Williamson I. Validation study of a diary for use in acute lower respiratory tract infection. Fam Pract. 2001;18(5):553–4.CrossRefPubMed
23.
Braun VC V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.CrossRef
24.
Little P, Rumsby K, Kelly J, Watson L, Moore M, Warner G, et al. Information leaflet and antibiotic prescribing strategies for acute lower respiratory tract infection—A randomized controlled trial. JAMA. 2005;293(24):3029–35.CrossRefPubMed
Metadata
Title
Uva-ursi extract and ibuprofen as alternative treatments of adult female urinary tract infection (ATAFUTI): study protocol for a randomised controlled trial
Authors
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
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2145-7

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Study protocol

The effect of an intensive smoking cessation intervention on disease activity in patients with rheumatoid arthritis: study protocol for a randomised controlled trial

Study protocol

Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial

Study protocol

Right median nerve electrical stimulation for acute traumatic coma (the Asia Coma Electrical Stimulation trial): study protocol for a randomised controlled trial

Research

Lessons from the field: the conduct of randomized controlled trials in Botswana

Study protocol

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial

Study protocol

Does the use of the Informed Healthcare Choices (IHC) primary school resources improve the ability of grade-5 children in Uganda to assess the trustworthiness of claims about the effects of treatments: protocol for a cluster-randomised trial