Rigid Versus Flexible Cystoscopy in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00214045
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 21, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hematuria Urination Disorders Voiding Dysfunction Recurrent Urinary Tract Infection Device: Flexible versus Rigid Cystoscopes Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Rigid Versus Flexible Cystoscopy in Women in Outpatient Clinic
Study Start Date : July 2004
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Flexible Cystoscopy
Flexible Cystoscopy
Device: Flexible versus Rigid Cystoscopes
Active Comparator: Rigid Cystoscopy
Rigid Cystoscopy
Device: Flexible versus Rigid Cystoscopes

Primary Outcome Measures :
  1. Pain ratings on a visual analog scale before, during and after cystoscopy in the clinic [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female

Exclusion Criteria:

  • Minors
  • Incarcerated individuals

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00214045

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Stephen Nakada, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison Identifier: NCT00214045     History of Changes
Obsolete Identifiers: NCT00590733
Other Study ID Numbers: 2004-0254
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 21, 2012
Last Verified: October 2012

Keywords provided by University of Wisconsin, Madison:
Bladder cancer surveillance
Voiding dysfunction

Additional relevant MeSH terms:
Urinary Tract Infections
Urination Disorders
Urologic Diseases
Pathologic Processes