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

Not Applicable

Completed

• Conditions: ncomplicated lower urinary tract infection; Urological and Genital Diseases; Urinary tract infection

• Registration Number: ISRCTN00470468
• Lead Sponsor: Georg-August University of Gottingen (Georg-August-Universitat Gottingen, Universitatsmedizin) (Germany)

Brief Summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21457558 2010 results in https://pubmed.ncbi.nlm.nih.gov/20504298/ (added 25/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-04
• Study Completion: 2008-04-15
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 79

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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)<br> 2. Feasibility: descriptive measure, this will be determined by describing the results of:<br> 2.1. Recruitment of General Practitioners (GPs)<br> 2.2. Recruitment of patients<br> 2.3. Number of complete/incomplete data sets<br> The feasibility will be assessed after the patient recruitment is finished.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Improvement of symptoms at days 4 and 7<br> 2. Adverse events<br> 3. Number of relapses<br> 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.<br>