NCT00214045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

April 30, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

4.9 years

First QC Date

September 13, 2005

Results QC Date

January 8, 2016

Last Update Submit

May 1, 2019

Conditions

HematuriaUrination DisordersVoiding DysfunctionRecurrent Urinary Tract Infection

Keywords

Bladder cancer surveillanceVoiding dysfunctionCystoscopy

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale for Pain

    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.

    During procedure and 1 week post-procedure

Study Arms (2)

Flexible Cystoscopy

ACTIVE COMPARATOR

Flexible Cystoscopy

Device: Flexible Cystoscopy

Rigid Cystoscopy

ACTIVE COMPARATOR

Rigid Cystoscopy

Device: Rigid Cystoscopy

Interventions

Flexible CystoscopyDEVICE
Flexible Cystoscopy
Rigid CystoscopyDEVICE
Rigid Cystoscopy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female

You may not qualify if:

  • Minors
  • Incarcerated individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

HematuriaUrination DisordersUrinary Tract Infections

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsInfections

Results Point of Contact

Title
Dr. Stephen Nakada
Organization
University of Wisconsin School of Medicine and Public Health
nakada@urology.wisc.edu
(608)263-1359

Study Officials

  • Stephen Nakada, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

July 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 15, 2019

Results First Posted

April 30, 2019

Record last verified: 2019-05

Locations

US(1)