- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00214045
Rigid Versus Flexible Cystoscopy in Women
May 1, 2019 updated by: University of Wisconsin, Madison
Rigid Versus Flexible Cystoscopy in Women in Outpatient Clinic
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
Exclusion Criteria:
- Minors
- Incarcerated individuals
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Flexible Cystoscopy
|
|
ACTIVE_COMPARATOR: Rigid Cystoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale for Pain
Time Frame: During procedure and 1 week post-procedure
|
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.
|
During procedure and 1 week post-procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (ACTUAL)
June 1, 2009
Study Completion (ACTUAL)
June 1, 2009
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (ESTIMATE)
September 21, 2005
Study Record Updates
Last Update Posted (ACTUAL)
May 15, 2019
Last Update Submitted That Met QC Criteria
May 1, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2004-0254
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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