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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.
 
ClinicalTrials.gov Identifier: NCT00214045
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : April 30, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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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 Cystoscopy Device: Rigid Cystoscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Flexible Cystoscopy
Flexible Cystoscopy
 Device: Flexible Cystoscopy
Active Comparator: Rigid Cystoscopy
Rigid Cystoscopy
 Device: Rigid Cystoscopy


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analog Scale for Pain [ Time Frame: 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.


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

Inclusion Criteria:

  • Female

Exclusion Criteria:

  • Minors
  • Incarcerated individuals
Contacts and Locations
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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
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Stephen Nakada, MD University of Wisconsin, Madison
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214045    
Obsolete Identifiers: NCT00590733
Other Study ID Numbers: H-2004-0254
First Posted: September 21, 2005    Key Record Dates
Results First Posted: April 30, 2019
Last Update Posted: May 15, 2019
Last Verified: May 2019
Keywords provided by University of Wisconsin, Madison:
Bladder cancer surveillance
Voiding dysfunction
Cystoscopy
Additional relevant MeSH terms:
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Urinary Tract Infections
Hematuria
Urination Disorders
Infections
 Urologic Diseases
Hemorrhage
Pathologic Processes