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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
History of Changes
  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 Blind (Subject)
Official Title: Rigid Versus Flexible Cystoscopy in Women in Outpatient Clinic

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female

Exclusion Criteria:

  • Minors
  • Incarcerated individuals
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214045     History of Changes
Obsolete Identifiers: NCT00590733
Other Study ID Numbers: 2004-0254
Study First Received: September 13, 2005
Last Updated: November 19, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013