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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014