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NCT00214045 Clinical Trial

Rigid Versus Flexible Cystoscopy in Women

Hematuria Clinical Trial

Official title:
Rigid Versus Flexible Cystoscopy in Women in Outpatient Clinic

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00214045
Other study ID # H-2004-0254
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2004
Est. completion date June 2009

Study information
Verified date May 2019
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Other known NCT identifiers
  • NCT00590733

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Female

Exclusion Criteria:

- Minors

- Incarcerated individuals

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Flexible Cystoscopy

• Rigid Cystoscopy

Locations
Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. During procedure and 1 week post-procedure
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