Antibiotics versus ibuprofen for uncomplicated lower urinary tract infections: a randomised controlled double-blind clinical trial in German general practices
| ISRCTN | ISRCTN00470468 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00470468 |
| Secondary identifying numbers | HWI-01 |
- Submission date
- 10/08/2007
- Registration date
- 04/10/2007
- Last edited
- 25/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Lower urinary tract infections (UTIs) are infections of the bladder or urethra (the tube that carries urine out of the body). They are usually treated with antibiotics. However, there is little evidence for alternative treatment options. The aim of this study is to find out whether the drug ibuprofen is as effective as the antibiotic ciprofloxacin for UTIs.
Who can participate?
Women aged 18 to 85 with at least one of the main UTI symptoms (painful/difficult or frequent urination)
What does the study involve?
Participants are randomly allocated to be treated with either ibuprofen or ciprofloxacin, both for three days. The intensity of their symptoms like painful/difficult or frequent urination and low abdominal pain are recorded at the start of the study and after 4, 7 and 28 days, scoring each symptom from 0 (none) to 4 (very strong).
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
29 German general practices
When is the study starting and how long is it expected to run for?
July 2007 to April 2008
Who is funding the study?
German Federal Ministry of Education and Research (Germany)
Who is the main contact?
Prof. Michael M. Kochen
mkochen@gwdg.de
Contact information
Scientific
Humboldtallee 38
Gottingen
37075
Germany
| mkochen@gwdg.de |
Study information
| Study design | Randomised controlled double-blind clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Antibiotics versus ibuprofen for uncomplicated lower urinary tract infections: a randomised controlled double-blind clinical trial in German general practices |
| Study hypothesis | 1. The study demonstrates the feasibility of a randomised controlled double-blind clinical trial in German general practices 2. The results of the ibuprofen group allow the conduction of a larger trial in which the equivalence of ibuprofen and ciprofloxacin in Urinary Tract Infections (UTI) will be tested |
| Ethics approval(s) | Local ethics committee (Ethikkommission der Universitaetsmedizin Goettingen), 13/06/2007, ref: 8/4/07 |
| Condition | Uncomplicated lower urinary tract infection |
| Intervention | There are two intervention arms: 1. Ciprofloxacin 2 x 250 mg for three days (and one placebo per day) 2. Ibuprofen 3 x 400 mg for three days |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ciprofloxacin, ibuprofen |
| Primary outcome measure | 1. Symptom score on day 4 (symptom score for dysuria, frequency and pain is measured on days 0, 4 and 7 by questionnaire and interviews) 2. Feasibility: descriptive measure, this will be determined by describing the results of: 2.1. Recruitment of General Practitioners (GPs) 2.2. Recruitment of patients 2.3. Number of complete/incomplete data sets The feasibility will be assessed after the patient recruitment is finished. |
| Secondary outcome measures | 1. Improvement of symptoms at days 4 and 7 2. Adverse events 3. Number of relapses The trial duration for each patient is 28 days. The adverse effects and relapses within these 28 days will be concerned. We plan to find out about this by an interview on day 28, and by data collection from GPs data at monitoring visits. |
| Overall study start date | 25/07/2007 |
| Overall study end date | 15/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 150 |
| Total final enrolment | 79 |
| Participant inclusion criteria | Women with typical symptoms of uncomplicated lower urinary tract infection (dysuria, frequency, lower abdominal pain) |
| Participant exclusion criteria | 1. Fever, low back pain 2. Urinary tract infection during the last two weeks 3. Current treatmant with antibiotics/Non-Steroidal Anti-Rheumatics (NSAR) 4. Pregnant/breastfeeding women 5. Diabetes 6. Renal diseases 7. Allergy/intolerance to ibuprofen/ciprofloxacin 8. Contraindications for trial medication 9. Severe co-morbidities |
| Recruitment start date | 25/07/2007 |
| Recruitment end date | 15/04/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
37075
Germany
Sponsor information
Hospital/treatment centre
c/o Professor M. M. Kochen
Humboldtallee 38
Gottingen
37075
Germany
| Website | http://www.uni-goettingen.de/en/sh/1.html |
|---|---|
"ROR" |
https://ror.org/01y9bpm73 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/04/2011 | Yes | No | |
| Results article | results | 26/05/2010 | 25/02/2021 | Yes | No |
Editorial Notes
25/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
18/10/2016: Plain English summary added.
