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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN00470468
Enrollment
150
Registered
2007-10-04
Start date
2007-07-25
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated lower urinary tract infection Urological and Genital Diseases Urinary tract infection

Interventions

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

Sponsors

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

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026