E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)
Not Applicable
Completed
- Conditions
- Urinary Tract Infection
- Interventions
- Biological: E. coli 83972
- Registration Number
- NCT00927316
- Lead Sponsor
- Region Skane
- Brief Summary
This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli 83972) protect against symptomatic urinary tract infections in individuals with bladder emptying dysfunctions and prone to recurrent infection episodes? The study is performed using a double-blind randomized study protocol with a cross-over, with re-inoculations being patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had bacteriuria or placebo-periods \< 12 months will be subjected to additional patient blinded inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients are unaware of urine culture results.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Recurrent UTI
- Bladder emptying dysfunction
- Optimal conservative treatment incl. clean intermittent catheterization
- Capable of "self reporting of UTI episodes"
Exclusion Criteria
- Malignant disease
- Immunosuppression
- Recurrent pyelonephritis
- Abnormalities within upper urinary tract, including renal stones and poor kidney function
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active arm E. coli 83972 E. coli 83972 bacteriuria Placebo arm E. coli 83972 Monitoring
- Primary Outcome Measures
Name Time Method Time to UTI 12 months Number of UTI During 12 months placebo or active treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Urology, Lund University
🇸🇪Lund, Sweden