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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Results First Submitted Date  ICMJE January 8, 2016
Results First Posted Date  ICMJE April 30, 2019
Last Update Posted Date May 15, 2019
Study Start Date  ICMJE July 2004
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Pain ratings on a visual analog scale during and after cystoscopy in the clinic
Change History Complete list of historical versions of study NCT00214045 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Duration (in days) after the procedure of the following: dysuria, hematuria, urinary frequency
  • Need to contact a health provider for complications from the procedure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Rigid Versus Flexible Cystoscopy in Women
Official Title  ICMJE Rigid Versus Flexible Cystoscopy in Women in Outpatient Clinic
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Hematuria
  • Urination Disorders
  • Voiding Dysfunction
  • Recurrent Urinary Tract Infection
Intervention  ICMJE
  • Device: Flexible Cystoscopy
  • Device: Rigid Cystoscopy
Study Arms  ICMJE
  • Active Comparator: Flexible Cystoscopy
    Flexible Cystoscopy
    Intervention: Device: Flexible Cystoscopy
  • Active Comparator: Rigid Cystoscopy
    Rigid Cystoscopy
    Intervention: Device: Rigid Cystoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2012)
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female

Exclusion Criteria:

  • Minors
  • Incarcerated individuals
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00214045
Other Study ID Numbers  ICMJE H-2004-0254
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Nakada, MD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP