NCT00177112

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

February 4, 2008

Status Verified

January 1, 2008

First QC Date

September 13, 2005

Last Update Submit

January 31, 2008

Conditions

Urinary Tract Infections

Keywords

Cystoscopy

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

clean patient preparation for cystoscopyPROCEDURE
sterile patient preparation for cystoscopyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Patients undergoing routine outpatient flexible cystoscopy

You may not qualify if:

  • Patients who have had a urinary tract infection within 3 months prior to flexible cystoscopy
  • Patients with an indwelling catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VAMC Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Kyle Anderson, MD

    VAMC Minneapolis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

June 1, 2005

Study Completion

October 1, 2007

Last Updated

February 4, 2008

Record last verified: 2008-01

Locations

US(1)