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

Sponsor

Region Skane (Other)

Overall Status

Completed

CT.gov ID

NCT00927316

Collaborator

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

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection	Biological: E. coli 83972	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Care Provider)

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.

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Time to UTI [12 months]
Number of UTI [During 12 months placebo or active treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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