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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hematuria
• Recurrent Urinary Tract Infection
• Urinary Tract Infections
• Urination Disorders
• Voiding Dysfunction

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