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

Urinary Tract Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927316
• Other study ID #: RTP-A2003
• Status: Completed
• Phase: N/A
• First received: June 22, 2009
• Last updated: November 9, 2009
• Start date: March 2003
• Est. completion date: December 2006

Study information

• Verified date: November 2009
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteriuria
• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Urology, Lund University	Lund

Sponsors (5)

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

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to UTI		12 months	No
Primary	Number of UTI		During 12 months placebo or active treatment	No