E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)
Induced Asymptomatic E. Coli 83972 Bacteriuria in Patients With Recurrent Urinary Tract Infections and Bladder Dysfunction- is There a Protective Effect Against Recurrent Symptomatic Infections? A Blinded Placebo Controlled Cross-over Study.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 22, 2009
CompletedFirst Posted
Study publicly available on registry
June 24, 2009
CompletedNovember 10, 2009
November 1, 2009
3.8 years
June 22, 2009
November 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to UTI
12 months
Number of UTI
During 12 months placebo or active treatment
Study Arms (2)
Active arm
ACTIVE COMPARATORE. coli 83972 bacteriuria
Placebo arm
PLACEBO COMPARATORMonitoring
Interventions
Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml). Placebo arm: Identical procedure but with saline, 30 ml.
Eligibility Criteria
You may qualify if:
- Recurrent UTI
- Bladder emptying dysfunction
- Optimal conservative treatment incl. clean intermittent catheterization
- Capable of "self reporting of UTI episodes"
You may not qualify if:
- Malignant disease
- Immunosuppression
- Recurrent pyelonephritis
- Abnormalities within upper urinary tract, including renal stones and poor kidney function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
- Coloplast A/Scollaborator
- Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Swedencollaborator
- Swedish Institute for Infectious Disease Controlcollaborator
- Lund University Hospitalcollaborator
Study Sites (1)
Department of Urology, Lund University
Lund, SE-221 85, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fredrik Sundén, MD
Dept. of Urology, University Hospital, 221 85 Lund
- STUDY CHAIR
Björn Wullt, MD, PhD
Dept. of Urology, Lund University Hospital, 221 85 Lund
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 22, 2009
First Posted
June 24, 2009
Study Start
March 1, 2003
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
November 10, 2009
Record last verified: 2009-11