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
Protocol serial number	HWI-01
Sponsor	Georg-August University of Gottingen (Georg-August-Universitat Gottingen, Universitatsmedizin) (Germany)
Funder	Bundesministerium für Bildung und Forschung

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Prof Michael M. Kochen
Scientific

Humboldtallee 38
Gottingen
37075
Germany

Email	mkochen@gwdg.de

Study information

Primary study design	Interventional
Study design	Randomised controlled double-blind clinical trial
Secondary study design	Randomised controlled trial
Study type	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 objectives	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
Health condition(s) or problem(s) studied	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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ciprofloxacin, ibuprofen
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	15/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	150
Total final enrolment	79
Key inclusion criteria	Women with typical symptoms of uncomplicated lower urinary tract infection (dysuria, frequency, lower abdominal pain)
Key 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
Date of first enrolment	25/07/2007
Date of final enrolment	15/04/2008

Locations

Countries of recruitment

Germany

Study participating centre

Georg-August University of Gottingen

Gottingen
37075
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	26/05/2010	25/02/2021	Yes	No
Protocol article	protocol	01/04/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.