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Completed

NCT Number: NCT00927316

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

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.

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Key information

Conditions

Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Lund University

Lund, SE-221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E. coli 83972

Biological

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.

Primary outcomes

  1. Time to UTI

    Time frame: 12 months

  2. Number of UTI

    Time frame: During 12 months placebo or active treatment

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Coloplast A/S
  • Lund University Hospital
  • Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden
  • Swedish Institute for Infectious Disease Control

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Jun 24, 2009
Registry last updated
Nov 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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