Condition category
Urological and Genital Diseases
Date applied
01/06/2006
Date assigned
13/06/2006
Last edited
21/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Recent evidence shows that substances found in cranberries might help in preventing recurrent urinary infections. Recurrent urinary infections are common and troubling in older women. The usual treatment is either repeated doses of antibiotic at the time of infection or continuous low doses of antibiotic for prolonged periods of time. Unfortunately antibiotics have unwanted effects and may harm the good bacteria of your gut and lead to the development of antibiotic resistant infections.
The aim of this study is to find out whether cranberry products will reduce the occurrence of urinary infections when compared to the usual treatment with low doses of trimethoprim (an antibiotic).

Who can participate?
Adult women aged 45 years or over who have had two UTIS or episodes of cystitis in the previous 12 months

What does the study involve?
The study lasts for 6 months. At the start, participants provide a sample of urine. They are randomly allocated to one of two groups. All participants take one capsule of study medication each day, which will contain either 100mg of trimethoprim, or 500mg of cranberry extract depending on their group.
During the 6 months in the study, participants are asked to report any urine infections you have, any courses of antibiotics you take, and any side effects that you experience. At the end of the 6 months, any spare study capsules that are left will be taken back and counted.

What are the possible benefits and risks of participating?
It is possible that participants will have fewer urine infections as a result of taking one of the study medications, but we do not know which one will prevent more infections.
There are no known side effects of cranberry product. Trimethoprim, a commonly used antibiotic, is the recommended treatment for urinary infections, but it can rarely cause side effects like upset stomach and rashes.

Where is the study run from?
Ninewells Hospital Dundee (UK)

When is the study starting and how long is it expected to run for?
September 2006 to August 2008

Who is funding the study?
Moulton Charitable Foundation (UK)

Who is the main contact?
Prof Marion McMurdo (Scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marion McMurdo

ORCID ID

Contact details

Ageing and Health
Division of Medicine and Therapeutics
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

2006-001313-15

ClinicalTrials.gov number

Protocol/serial number

555555

Study information

Scientific title

Cranberry or trimethoprim for the prevention of recurrent urinary tract infections? A randomized controlled trial in older women

Acronym

Study hypothesis

1. What is the relative effectiveness of low dose trimethoprim compared to cranberry product in the prevention of urinary tract infections in older women with recurrent infections?
2. What is the acceptability of and adherence to both preventative treatments?

Ethics approval

Tayside Committee of Medical Research Ethics, 23/03/2006, ref: 06/S1402/23

Study design

Double-blind, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Recurrent urinary tract infections

Intervention

Trimethoprim 100 mg daily versus 500 mg cranberry product daily

Intervention type

Drug

Phase

Not Specified

Drug names

Trimethoprim

Primary outcome measure

Current primary outcome measure (as of 21/02/2018:)
First recurrence of symptomatic urinary tract infection self reported by patient during 6 month study

Previous primary outcome measure:
First recurrence of symptomatic urinary tract infection

Secondary outcome measures

Current secondary outcome measures (as of 21/02/2018):
Acceptability and adherence, measured by number of capsules left at the end of the 6 month study

Previous secondary outcome measure:
Acceptability and adherence

Overall trial start date

01/09/2006

Overall trial end date

31/08/2008

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Community dwelling women aged 45 years or over with at least two antibiotic-treated urinary tract infections or episodes of cystitis in the previous 12 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Previous urological surgery, stone or anatomical abnormalities
2. Urinary catheter
3. Diabetes mellitus
4. Immunocompromised
5. Pyelonephritis
6. Severe renal impairment
7. Blood dyscrasia
8. Symptomatic urinary tract infection (UTI) at baseline
9. Cognitive impairment precluding informed consent
10. Resident in institutional care
11. On longterm antibiotics
12. On warfarin therapy
13. Regular cranberry consumers
14. Unwilling to participate

Recruitment start date

01/09/2006

Recruitment end date

31/08/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ageing and Health
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Research and Innovation Services
University of Dundee
Dundee
DD1 4HN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Moulton Charitable Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

IPD sharing statement: Individual participant data are not available for sharing

Intention to publish date

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19042940

Publication citations

  1. Results

    McMurdo ME, Argo I, Phillips G, Daly F, Davey P, Cranberry or trimethoprim for the prevention of recurrent urinary tract infections? A randomized controlled trial in older women., J. Antimicrob. Chemother., 2009, 63, 2, 389-395, doi: 10.1093/jac/dkn489.

Additional files

Editorial Notes

21/02/2018: The following changes were made: 1. Scientific title, plain english summary and participant level data were added. 2. Primary and secondary outcome measures were updated. 3. Basic results Summary was added.