Flexible vs Rigid Cytoscopy in Women

This study is ongoing, but not recruiting participants.

First Received: December 26, 2007 Last Updated: June 2, 2008 History of Changes

Sponsor:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00590733

Purpose

This study will help define the best tolerated approach to cystoscopy by randomly comparing the flexible to the rigid cystoscope.

Condition	Intervention
Bladder Cancer Bladder Stones Hematuria Structural Abnormalities Voiding Dysfunction	Device: cystoscope

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Single Group Assignment
Official Title:	Flexible vs Rigid Cytoscopy in Women

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Urine and Urination

U.S. FDA Resources

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

Primary Outcome Measures:

discomfort questionnaire [ Time Frame: During and Immediately following procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

second discomfort questionnaire [ Time Frame: One week following procedure ] [ Designated as safety issue: No ]

Enrollment:	33
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
flexible cystoscope: Active Comparator	Device: cystoscope flexible compared to rigid cystoscope
rigid cystoscope: Active Comparator	Device: cystoscope rigid cystoscope compared to flexible cystoscope

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

women who are undergoing cystoscopy

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590733

Locations

United States, Wisconsin
Division of Urology, University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Stephen Y Nakada, MD

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin ( Stephen Y. Nakada )
Study ID Numbers:	H-2004-0254
Study First Received:	December 26, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00590733 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

flexible cystoscope rigid cystoscope, cystoscopy

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Urination Disorders
Urolithiasis
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Hemorrhage
Calculi

Urologic Neoplasms
Urinary Bladder Calculi
Neoplasms
Pathologic Processes
Neoplasms by Site
Hematuria
Urologic Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 30, 2009