Cranberry product versus low dose trimethoprim in the prevention of recurrent urinary infections in older women: a double blind randomised trial of effectiveness and acceptability
| ISRCTN | ISRCTN80031108 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80031108 |
| EudraCT/CTIS number | 2006-001313-15 |
| Secondary identifying numbers | 555555 |
- Submission date
- 01/06/2006
- Registration date
- 13/06/2006
- Last edited
- 21/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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)
Contact information
Scientific
Ageing and Health
Division of Medicine and Therapeutics
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Double-blind, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | Cranberry or trimethoprim for the prevention of recurrent urinary tract infections? A randomized controlled trial in older women |
| Study objectives | 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(s) | Tayside Committee of Medical Research Ethics, 23/03/2006, ref: 06/S1402/23 |
| Health condition(s) or problem(s) studied | Recurrent urinary tract infections |
| Intervention | Trimethoprim 100 mg daily versus 500 mg cranberry product daily |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2006 |
| Completion date | 31/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 31/08/2008 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
DD1 9SY
United Kingdom
Sponsor information
University/education
Research and Innovation Services
University of Dundee
Dundee
DD1 4HN
Scotland
United Kingdom
"ROR" |
https://ror.org/03h2bxq36 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| IPD sharing plan | Individual participant data are not available for sharing |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2009 | Yes | No | |
| Basic results | 21/02/2018 | 21/02/2018 | No | No |
Additional files
- ISRCTN80031108_BasicResults_21Feb18.pdf
- Uploaded: 21/02/2018
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.
