Back to resultsImpact of Sterilization Technique on Incidence of Urinary Tract Infection After Cystoscopy
Primary Purpose
Urinary Tract Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
clean patient preparation for cystoscopy
sterile patient preparation for cystoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infections focused on measuring Cystoscopy
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Patients undergoing routine outpatient flexible cystoscopy Exclusion Criteria: Patients who have had a urinary tract infection within 3 months prior to flexible cystoscopy Patients with an indwelling catheter
Sites / Locations
- VAMC Minneapolis
Outcomes
Primary Outcome Measures
To verify that the incidence rate of urinary tract infections after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile procedural techniques
Secondary Outcome Measures
Full Information
NCT ID
NCT00177112
First Posted
September 13, 2005
Last Updated
January 31, 2008
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT00177112
Brief Title
Impact of Sterilization Technique on Incidence of Urinary Tract Infection After Cystoscopy
Official Title
Impact of Sterilization Technique on Incidence of Urinary Tract Infection After Cystoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Minnesota
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to verify that the incidence rate of urinary tract infections after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile procedural techniques.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Cystoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
275 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
clean patient preparation for cystoscopy
Intervention Type
Procedure
Intervention Name(s)
sterile patient preparation for cystoscopy
Primary Outcome Measure Information:
Title
To verify that the incidence rate of urinary tract infections after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile procedural techniques
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Patients undergoing routine outpatient flexible cystoscopy
Exclusion Criteria:
Patients who have had a urinary tract infection within 3 months prior to flexible cystoscopy
Patients with an indwelling catheter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Anderson, MD
Organizational Affiliation
VAMC Minneapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
VAMC Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Sterilization Technique on Incidence of Urinary Tract Infection After Cystoscopy
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