Condition category
Urological and Genital Diseases
Date applied
10/08/2007
Date assigned
04/10/2007
Last edited
18/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael M. Kochen

ORCID ID

Contact details

Humboldtallee 38
Gottingen
37075
Germany
-
mkochen@gwdg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HWI-01

Study information

Scientific title

Antibiotics versus ibuprofen for uncomplicated lower urinary tract infections: a randomised controlled double-blind clinical trial in German general practices

Acronym

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

Local ethics committee (Ethikkommission der Universitaetsmedizin Goettingen), 13/06/2007, ref: 8/4/07

Study design

Randomised controlled double-blind clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Not Applicable

Drug names

Ciprofloxacin, ibuprofen

Primary outcome measures

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 trial start date

25/07/2007

Overall trial end date

15/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Women with typical symptoms of uncomplicated lower urinary tract infection (dysuria, frequency, lower abdominal pain)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

150

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

Trial participating centre

Georg-August University of Gottingen
Gottingen
37075
Germany

Sponsor information

Organisation

Georg-August University of Gottingen (Georg-August-Universitat Gottingen, Universitatsmedizin) (Germany)

Sponsor details

c/o Professor M. M. Kochen
Humboldtallee 38
Gottingen
37075
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.uni-goettingen.de/en/sh/1.html

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

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

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21457558

Publication citations

  1. Protocol

    Gágyor I, Bleidorn J, Wegscheider K, Hummers-Pradier E, Kochen MM, Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices., Trials, 2011, 12, 91, doi: 10.1186/1745-6215-12-91.

Additional files

Editorial Notes

18/10/2016: Plain English summary added.