Rigid Versus Flexible Cystoscopy in Women

Not Applicable

Completed

• Conditions: Hematuria; Urination Disorders; Voiding Dysfunction; Recurrent Urinary Tract Infection
• Interventions: Device: Rigid Cystoscopy; Device: Flexible Cystoscopy

• Registration Number: NCT00214045
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2016-01-08
• Results First Submitted QC: 2019-04-11
• Results First Posted: 2019-04-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-01
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Female

Exclusion Criteria

• Minors
• Incarcerated individuals

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rigid Cystoscopy	Rigid Cystoscopy	Rigid Cystoscopy
Flexible Cystoscopy	Flexible Cystoscopy	Flexible Cystoscopy

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale for Pain	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.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States