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Clinical Trials/EUCTR2008-007669-21-BE
EUCTR2008-007669-21-BE
Active, not recruiting
Phase 1

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)

CHU of Liège0 sites350 target enrollmentNovember 30, 2009
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ConditionsThe 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
DrugsMonuril

Overview

Phase
Phase 1
Intervention
Not specified
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
Sponsor
CHU of Liège
Enrollment
350
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 30, 2009
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
CHU of Liège

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •History of recurrent urinary tract infection
  • •Impaired renal function
  • •Intermittent self\-catheterization
  • •Presence of persistent urinary infection \*
  • •Breastfeeding
  • •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

Outcomes

Primary Outcomes

Not specified

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