Rigid Versus Flexible Cystoscopy in Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214045
First received: September 13, 2005
Last updated: November 19, 2012
Last verified: October 2012

September 13, 2005
November 19, 2012
July 2004
June 2009   (final data collection date for primary outcome measure)
Pain ratings on a visual analog scale before, during and after cystoscopy in the clinic [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Pain ratings on a visual analog scale during and after cystoscopy in the clinic
Complete list of historical versions of study NCT00214045 on ClinicalTrials.gov Archive Site
Not Provided
  • Duration (in days) after the procedure of the following: dysuria, hematuria, urinary frequency
  • Need to contact a health provider for complications from the procedure
Not Provided
Not Provided
 
Rigid Versus Flexible Cystoscopy in Women
Rigid Versus Flexible Cystoscopy in Women in Outpatient Clinic

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
  • Hematuria
  • Urination Disorders
  • Voiding Dysfunction
  • Recurrent Urinary Tract Infection
Device: Flexible versus Rigid Cystoscopes
  • Active Comparator: Flexible Cystoscopy
    Flexible Cystoscopy
    Intervention: Device: Flexible versus Rigid Cystoscopes
  • Active Comparator: Rigid Cystoscopy
    Rigid Cystoscopy
    Intervention: Device: Flexible versus Rigid Cystoscopes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female

Exclusion Criteria:

  • Minors
  • Incarcerated individuals
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214045
2004-0254
No
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Stephen Nakada, MD University of Wisconsin, Madison
University of Wisconsin, Madison
October 2012

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