Effectiveness of prophylactic antibiotic intervention (fosfomycin trometamol) to prevent urinary tract infections due to urodynamic studies in women with urine incontinence or prolapsed: a randomized controlled trial - USA (Urodynamic Studies Antibioprophylaxy)
- Conditions
- The aim of the study is to assess the prophylactic use of antibiotics on urinary tract infection after urodynamic studies in women with incontinence or prolapse
- Registration Number
- EUCTR2008-007669-21-BE
- Lead Sponsor
- CHU of Liège
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 350
1. women aged 18- 80 years
2. attending the urodynamic outpatient clinic of the Department of Obstetrics and Gynecology at CHR La Citadelle, Liège for urodynamic investigations
3. without symptoms of urogenital infection at the time of UDS attested by a positive result at stick test of urinary sample
4. intellectually and/or linguistically able to understand the study
5. not suffering from mental disabilities (except depression and anxiety)
6. resident within the surroundings of Liege.
7. willing to give their written consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
History of recurrent urinary tract infection
Impaired renal function
Intermittent self-catheterization
Presence of persistent urinary infection *
Breastfeeding
Pregnancy
Short term child-bearing potential**
Allergy to antibiotics
Antibiotics in the previous 7 days
* urinary infection - indicated by a positive stick test for nitrites and/or pyuria - which does not respond adequately to fosfomycin trometamol administration on the long term (1 month)
**sexually active women who apply an unreliable method of birth control or who have an acute wish to become pregnant
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The present study, a prospective randomized trial addresses the following question: What is the efficacy of a double 3 g dose of oral fosfomycin (Monuril) administered 2 hours before and after urodynamic investigations (UDS) and compared to placebo in order to prevent de novo urinary tract infection?<br><br>By answering that question, it will be possible to know whether it is useful to administer prophylactic antibiotics when performing UDS and if 2x 3g of fosfomycin is effective against most of the bacteria that are encountered. <br>;Secondary Objective: none;Primary end point(s): 1. the presence of significant bacteriuria defined by more than 10,000 bacteria per millilitre of clean catch urine on culture obtained on day 3 after the UDS.<br>2. Caracterisation of the bacteria strains about their resistance to the standard antibiotic screening in the CHR microbiology Laboratory<br>
- Secondary Outcome Measures
Name Time Method