Non-antibiotic versus Antibiotic Prophylaxis for Recurrent Urinary Tract Infections
| ISRCTN | ISRCTN50717094 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50717094 |
| Secondary identifying numbers | Project 6200.0017 (ZonMw); NTR79 |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 10/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Urinary tract infections (UTIs) are very common infections in women. For women with UTIs which happen more than twice a year, low dose antibiotic prophylaxis (preventative treatment) for several months can be recommended. However, this can lead to resistance of not only the bacteria responsible for the UTI but also of all the natural bacterial found on/in a healthy person.
Previous studies have demonstrated that prophylaxis with non-antibiotic compounds (lactobacilli oral therapy) compared with a dummy treatment may lead to a lower number of new UTI episodes. Cranberry juice, compared with a dummy treatment, has also resulted in fewer UTIs in women. This study aims to compare these forms of non-antibiotic prophylaxis to antibiotic prophylaxis.
Who can participate?
Women who have an indication for prophylaxis of recurrent UTIs.
What does the study involve?
Participants will be randomly allocated to one of four treatments. In study A, 280 pre-menopausal women will receive either cranberry capsules or standardized antibiotic treatment. In study B, 280 postmenopausal women will receive either lactobacilli oral therapy or standardized antibiotic treatment.
Each month, during 15 months, all patients have to fill in a short questionnaire and to collect urine, faeces and a vaginal swab. At the beginning of the study and after 6,12 and 15 months they will have to fill in a longer questionnaire about quality of life.
What are the possible benefits and risks of participating?
Not provided.
Where is the study run from?
Academic Medical Center, Amsterdam, the Netherlands.
When is the study starting and how long is it expected to run for?
September 2005 to September 2009
Who is funding the study?
The work was supported by the Netherlands Organization for Health Research and Development
Who is the main contact?
NAPRUTI@amc.uva.nl
Contact information
Scientific
Academic Medical Centre
Dep Infectieziekten, tropische geneeskunde en AIDS
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5667921 |
|---|---|
| M.A.Beerepoot@amc.uva.nl |
Study information
| Study design | Multicentre, randomised, double blinded, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | The NAPRUTI-study. |
| Study hypothesis | Not provided at time of registration |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Condition | Urinary tract infections |
| Intervention | In trial A, 280 pre-menopausal women will receive either cranberry capsules (twice daily 500 mg) or standardised antibiotic treatment (once daily 480 mg trimethoprim-sulfamethoxazole [TMP/SMX]). In trial B, 280 postmenopausal women will receive either lactobacilli oral therapy (twice daily a capsule with greater than 10^9 Lactobacillus rhamnosus GR-1 and L. reuteri RC-14) or standardised antibiotic treatment (480 mg TMP/SMX). The double-dummy method is used for blinding. Each patient receives one tablet and two capsules daily, but only one of them (the tablet or the capsules) contains the active substance. All study medication must be taken for the duration of 12 months. During the treatment period and the three months after stopping the treatment (wash-out period), each month patients have to fill in a short questionnaire and collect urine, faeces and a vaginal swab for culturing. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cranberry capsule, trimethoprim-sulfamethoxazole, lactobacilli oral therapy |
| Primary outcome measure | 1. The numbers of recurrences of symptomatic UTI 2. Time to first occurrence of antibiotic resistance in urine or faeces |
| Secondary outcome measures | 1. Incidence of other infections 2. Incidence of asymptomatic bacteriuria events 3. Quality of life 4. Costs per prevented UTI |
| Overall study start date | 01/09/2005 |
| Overall study end date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 560 |
| Participant inclusion criteria | 1. Women aged 18 years or older 2. At least three symptomatic urinary tract infections (UTIs), uncomplicated or complicated, in the year preceding study inclusion OR already using any form of prophylaxis to prevent recurrences of urinary tract infections and at least three symptomatic urinary tract infections in the year befort the start of the prophylaxis |
| Participant exclusion criteria | 1. Life expectancy less than or equal to one year 2. Legally incapable 3. A renal transplant in the medical history 4. Contraindications for or relevant interactions with trimethoprim-sulfamethoxazole (TMP/SMX) 5. Additional exclusion criteria for trial A (pre-menopausal women randomised to either cranberry capsules or TMP/SMX): 5.1. Breastfeeding, pregnancy, or pregnancy wish for the next year 5.2. Contraindications for or relevant interactions with cranberries |
| Recruitment start date | 01/09/2005 |
| Recruitment end date | 01/09/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1105 AZ
Netherlands
Sponsor information
Hospital/treatment centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results of cranberries vs antibiotics | 25/07/2011 | Yes | No | |
| Results article | results of lactobacilli vs antibiotics | 14/05/2012 | Yes | No | |
| Results article | results | 04/04/2014 | Yes | No |
