Impact of Sterilization Technique on Incidence of Urinary... | NCT00177112

Studies
Impact of Sterilization Technique on Incidence of Urinary Tract Infection After Cystoscopy

NCT00177112

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Feb 4, 2008Estimated

Enrollment

275Estimated

Phase

Phase 3

Conditions

Urinary Tract Infections

Interventions

clean patient preparation for cystoscopy
sterile patient preparation for cystoscopy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
3519A

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2008

Last Update Posted Date

Feb 4, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

275Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyle Anderson, MD	VAMC Minneapolis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VAMC Minneapolis		Minneapolis	Minnesota	55417	United States

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003558	Cystoscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
clean patient preparation for cystoscopy	Procedure
sterile patient preparation for cystoscopy	Procedure