Rigid Versus Flexible Cystoscopy in Women

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00214045
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 59
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematuria; Urination Disorders; Voiding Dysfunction; Recurrent Urinary Tract Infection	Device: Flexible Cystoscopy; Device: Rigid Cystoscopy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Rigid Versus Flexible Cystoscopy in Women in Outpatient Clinic
• Study Start Date: Jul 1, 2004
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Flexible Cystoscopy Flexible Cystoscopy	Device: Flexible Cystoscopy
Active Comparator: Rigid Cystoscopy Rigid Cystoscopy	Device: Rigid Cystoscopy

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale for Pain [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Female

Exclusion Criteria:

• Minors

• Incarcerated individuals

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00214045
• Other Study ID Numbers: H-2004-0254; NCT00590733
• First Posted: Sep 21, 2005
• Last Update Posted: May 15, 2019
• Last Verified: May 1, 2019

• Keywords provided by University of Wisconsin, Madison: Bladder cancer surveillance; Voiding dysfunction; Cystoscopy
• Additional relevant MeSH terms: Urinary Tract Infections; Hematuria; Urination Disorders

Study Results

Participant Flow

Arm/Group Title	Flexible Cystoscopy	Rigid Cystoscopy
Arm/Group Description	Use of Flexible Cystoscope during clinically indicated cystoscopy	Use of Rigid Cystoscope during clinically indicated cystoscopy
Period Title: Overall Study
STARTED	18	18
COMPLETED	18	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Flexible Cystoscopy	Rigid Cystoscopy	Total
Arm/Group Description	Use of Flexible Cystoscope during clinically indicated cystoscopy	Use of Rigid Cystoscope during clinically indicated cystoscopy	Total of all reporting groups
Overall Participants	18	18	36
Age, Customized (participants) [Number]
Minors, <18 yrs	0 0%	0 0%	0 0%
Adults, >=18 yrs	18 100%	18 100%	36 100%
Sex: Female, Male (Count of Participants)
Female	18 100%	18 100%	36 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	18 100%	18 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scale for Pain
Description	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.
Time Frame	During procedure and 1 week post-procedure

Outcome Measure Data

Analysis Population Description

Per protocol.

Arm/Group Title	Rigid	Flexible
Arm/Group Description	Rigid	Flexible
Measure Participants	18	18
Mean (Standard Deviation) [Units on a Scale]	1.8 (0.2)	1.4 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rigid, Flexible
	Comments
	Type of Statistical Test	Superiority or Other
	Comments	Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.
Statistical Test of Hypothesis	p-Value	.39
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rigid, Flexible
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.
Statistical Test of Hypothesis	p-Value	0.37
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	Flexible Cystoscopy		Rigid Cystoscopy
Arm/Group Description	Use of Flexible Cystoscope during clinically indicated cystoscopy		Use of Rigid Cystoscope during clinically indicated cystoscopy
All Cause Mortality
	Flexible Cystoscopy		Rigid Cystoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Flexible Cystoscopy		Rigid Cystoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Flexible Cystoscopy		Rigid Cystoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.