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Rigid Versus Flexible Cystoscopy in Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00214045
First Posted: September 21, 2005
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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 Intervention
Hematuria Urination Disorders Voiding Dysfunction Recurrent Urinary Tract Infection Device: Flexible versus Rigid Cystoscopes

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Rigid Versus Flexible Cystoscopy in Women in Outpatient Clinic

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

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

Enrollment: 36
Study Start Date: July 2004
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Flexible Cystoscopy
Flexible Cystoscopy
Device: Flexible versus Rigid Cystoscopes
Active Comparator: Rigid Cystoscopy
Rigid Cystoscopy
Device: Flexible versus Rigid Cystoscopes

  Eligibility

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
Criteria

Inclusion Criteria:

  • Female

Exclusion Criteria:

  • Minors
  • Incarcerated individuals
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00214045


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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214045     History of Changes
Obsolete Identifiers: NCT00590733
Other Study ID Numbers: 2004-0254
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: October 12, 2017
Last Verified: October 2012

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

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