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

NCT ID: NCT00927316

Last Updated: 2009-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2006-12-31

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.

Conditions

Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Active arm

E. coli 83972 bacteriuria

Group Type: ACTIVE_COMPARATOR

E. coli 83972

Intervention Type: 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.

Placebo arm

Monitoring

Group Type: PLACEBO_COMPARATOR

E. coli 83972

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: collaborator

Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden

UNKNOWN

Sponsor Role: collaborator

Swedish Institute for Infectious Disease Control

OTHER

Sponsor Role: collaborator

Lund University Hospital

OTHER

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Dept. of Urology, University Hospital, Lund, Sweden

Principal Investigators

Fredrik Sundén, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Urology, University Hospital, 221 85 Lund

Björn Wullt, MD, PhD

Role: STUDY_CHAIR

Dept. of Urology, Lund University Hospital, 221 85 Lund

Locations

Department of Urology, Lund University

Lund, , Sweden

Countries

Sweden

Other Identifiers

RTP-A2003

Identifier Type: -

Identifier Source: org_study_id