Condition category
Urological and Genital Diseases
Date applied
01/06/2006
Date assigned
13/06/2006
Last edited
08/12/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

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

ClinicalTrials.gov number

Protocol/serial number

555555

Study information

Scientific title

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

Approval granted by the Tayside Committee of Medical Research Ethics on 23rd March 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 measures

First recurrence of symptomatic urinary tract infection

Secondary outcome measures

Acceptability and adherence

Overall trial start date

01/09/2006

Overall trial end date

31/08/2008

Reason abandoned

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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