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E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)

This study has been completed.
Sponsor:
Collaborators:
Coloplast A/S
Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden
Swedish Institute for Infectious Disease Control
Lund University Hospital
Information provided by:
Region Skane
ClinicalTrials.gov Identifier:
NCT00927316
First received: June 22, 2009
Last updated: November 9, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Urinary Tract Infection
 Biological: E. coli 83972

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Time to UTI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of UTI [ Time Frame: During 12 months placebo or active treatment ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active arm
E. coli 83972 bacteriuria
 Biological: E. coli 83972

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.
Placebo Comparator: Placebo arm
Monitoring
 Biological: E. coli 83972

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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927316

Locations
Sweden
Department of Urology, Lund University
Lund, Sweden, SE-221 85
Sponsors and Collaborators
Region Skane
Coloplast A/S
Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden
Swedish Institute for Infectious Disease Control
Lund University Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Fredrik Sundén, MD, Dept. of Urology, University Hospital, Lund, Sweden
ClinicalTrials.gov Identifier: NCT00927316     History of Changes
Other Study ID Numbers: RTP-A2003
Study First Received: June 22, 2009
Last Updated: November 9, 2009
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
Report of Urinary Tract Infection episode

Additional relevant MeSH terms:
Bacteriuria
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013