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

Primary Purpose

Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
E. coli 83972
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infection focused on measuring Report of Urinary Tract Infection episode

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Urology, Lund University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active arm

Placebo arm

Arm Description

E. coli 83972 bacteriuria

Monitoring

Outcomes

Primary Outcome Measures

Time to UTI
Number of UTI

Secondary Outcome Measures

Full Information

First Posted
June 22, 2009
Last Updated
November 9, 2009
Sponsor
Region Skane
Collaborators
Coloplast A/S, Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden, Swedish Institute for Infectious Disease Control, Lund University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00927316
Brief Title
E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
Report of Urinary Tract Infection episode

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active arm
Arm Type
Active Comparator
Arm Description
E. coli 83972 bacteriuria
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Monitoring
Intervention Type
Biological
Intervention Name(s)
E. coli 83972
Intervention Description
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 Outcome Measure Information:
Title
Time to UTI
Time Frame
12 months
Title
Number of UTI
Time Frame
During 12 months placebo or active treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Sundén, MD
Organizational Affiliation
Dept. of Urology, University Hospital, 221 85 Lund
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Björn Wullt, MD, PhD
Organizational Affiliation
Dept. of Urology, Lund University Hospital, 221 85 Lund
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Urology, Lund University
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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