Back to resultsRigid Versus Flexible Cystoscopy in Women
Primary Purpose
Hematuria, Urination Disorders, Voiding Dysfunction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flexible Cystoscopy
Rigid Cystoscopy
Sponsored by
About this trial
This is an interventional other trial for Hematuria focused on measuring Bladder cancer surveillance, Voiding dysfunction, Cystoscopy
Eligibility Criteria
Inclusion Criteria: Female Exclusion Criteria: Minors Incarcerated individuals
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Flexible Cystoscopy
Rigid Cystoscopy
Arm Description
Flexible Cystoscopy
Rigid Cystoscopy
Outcomes
Primary Outcome Measures
Visual Analog Scale for Pain
The Visual Analog Scale for pain ranges from 1 to 5, with higher scores indicating higher pain. Results report the average of two measures, taken during procedure and 1 week post-procedure.
Secondary Outcome Measures
Full Information
NCT ID
NCT00214045
First Posted
September 13, 2005
Last Updated
May 1, 2019
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00214045
Brief Title
Rigid Versus Flexible Cystoscopy in Women
Official Title
Rigid Versus Flexible Cystoscopy in Women in Outpatient Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will help define the best tolerated approach to cystoscopy in women by randomly comparing flexible to rigid cystoscopy. Previous randomized studies evaluated rigid cystoscopy under general anesthesia versus flexible cystoscopy under local anesthesia. As a result of these studies, flexible cystoscopy is performed in the clinic setting generally in males. However, many women have rigid cystoscopy performed in the clinic while the men have flexible cystoscopy. No studies to date have evaluated whether flexible cystoscopy is better tolerated in women compared to rigid cystoscopy in women in the clinic setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematuria, Urination Disorders, Voiding Dysfunction, Recurrent Urinary Tract Infection
Keywords
Bladder cancer surveillance, Voiding dysfunction, Cystoscopy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flexible Cystoscopy
Arm Type
Active Comparator
Arm Description
Flexible Cystoscopy
Arm Title
Rigid Cystoscopy
Arm Type
Active Comparator
Arm Description
Rigid Cystoscopy
Intervention Type
Device
Intervention Name(s)
Flexible Cystoscopy
Intervention Type
Device
Intervention Name(s)
Rigid Cystoscopy
Primary Outcome Measure Information:
Title
Visual Analog Scale for Pain
Description
The Visual Analog Scale for pain ranges from 1 to 5, with higher scores indicating higher pain. Results report the average of two measures, taken during procedure and 1 week post-procedure.
Time Frame
During procedure and 1 week post-procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female
Exclusion Criteria:
Minors
Incarcerated individuals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Nakada, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
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Rigid Versus Flexible Cystoscopy in Women
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