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Rigid Versus Flexible Cystoscopy in Women

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ClinicalTrials.gov Identifier: NCT00214045
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : April 30, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Conditions Hematuria
Urination Disorders
Voiding Dysfunction
Recurrent Urinary Tract Infection
Interventions Device: Flexible Cystoscopy
Device: Rigid Cystoscopy
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Flexible Cystoscopy Rigid Cystoscopy
Hide 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
Arm/Group Title Flexible Cystoscopy Rigid Cystoscopy Total
Hide 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 Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Minors, <18 yrs 0 0 0
Adults, >=18 yrs 18 18 36
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
18
 100.0%
18
 100.0%
36
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 18 participants 36 participants
18 18 36
1.Primary Outcome
Title Visual Analog Scale for Pain
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol.
Arm/Group Title Rigid Flexible
Hide Arm/Group Description:
Rigid
Flexible
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
1.8  (0.2) 1.4  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rigid, Flexible
Comments [Not Specified]
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 [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rigid, Flexible
Comments [Not Specified]
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 [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flexible Cystoscopy Rigid Cystoscopy
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Flexible Cystoscopy Rigid Cystoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Flexible Cystoscopy Rigid Cystoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Stephen Nakada
Organization: University of Wisconsin School of Medicine and Public Health
Phone: (608)263-1359
EMail: nakada@urology.wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214045     History of Changes
Obsolete Identifiers: NCT00590733
Other Study ID Numbers: H-2004-0254
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: January 8, 2016
Results First Posted: April 30, 2019
Last Update Posted: May 15, 2019