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Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better? (BWash)

Primary Purpose

Bladder Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Flexible cystoscopy
Urinary catheter
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring Bladder cancer, Urinary cytology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Men aged > or = 18 years Patients scheduled for a flexible cystoscopy and urinary cytology. Patients who have signed the informed consent. Patients who speak French Exclusion Criteria: Manipulations or instrumentation of urinary tract, including but not limited to Double-J stent placement or removal, and/or bladder biopsy Inability to give informed consent or without capacity of discernment

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois, CHUVRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

urinary catheter

flexible cystoscope

Arm Description

Urinary cytology will be collected using a Ch.14 bladder catheter after the removal of the cystoscope. Catheter will be placed at the bladder neck level.

Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present).

Outcomes

Primary Outcome Measures

The quality of urinary cytology according to the tool used for collection of both groups
Number of urothelial cells, number of inflammatory cells, presence of necrosis or blood will be used to assess this outcome measure

Secondary Outcome Measures

The sensitivity and sensibility of the urinary cytology of both groups
Sensitivity ans specificity percentage will be calculated based on the results of both urinary cytology and cystoscopy
The satisfaction of patients of both groups
The Faces Pain Scale will be used for each patient after the cytology to assess his satisfaction/pain (0= no pain and 10=the worst pain possible)

Full Information

First Posted
November 21, 2022
Last Updated
February 9, 2023
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT05643807
Brief Title
Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better?
Acronym
BWash
Official Title
Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better? A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Urine cytology can be collected with spontaneous urine or by washing the bladder. It is commonly accepted among urologist that instrumental bladder washing is the method of choice. There are, however, no solid recommendations regarding the method to collect the urine for bladder wash cytology during cystoscopy. There are mainly two possibilities: 1) the use of an intermittent bladder catheter after the removal of the cystoscope or 2) bladder lavage through working channel of the flexible cystoscope itself. The first choice may increase the number of collected cells because of the larger caliber of the catheter compared to the working channel and thus the better efficacy of bladder wash. However, this method is certainly more invasive and possibly more expensive. To the best of our knowledge and according to available literature, none of both collection method can be defined as gold standard. The aim of the study is to show that use of flexible cystoscope brings the same results in terms of quality of the urine collection for analysis as the use of intermittent bladder catheter and is less unpleasant for the patient. If our study confirms the non-inferiority of "direct" collection through the cystoscope, this will allow the establishment of recommendations in this sense in order to simplify the procedure and reduce as much as possible the manipulations within the urogenital tract.
Detailed Description
The aim of the study is to show that use of flexible cystoscope brings the same results in terms of quality of the urine collection for analysis as the use of intermittent bladder catheter and is less unpleasant for the patient. Group A: Urinary cytology will be collected using a Ch.14 bladder catheter after the removal of the cystoscope. Catheter will be placed at the bladder neck level. Group B: Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Bladder cancer, Urinary cytology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
urinary catheter
Arm Type
Active Comparator
Arm Description
Urinary cytology will be collected using a Ch.14 bladder catheter after the removal of the cystoscope. Catheter will be placed at the bladder neck level.
Arm Title
flexible cystoscope
Arm Type
Active Comparator
Arm Description
Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present).
Intervention Type
Device
Intervention Name(s)
Flexible cystoscopy
Intervention Description
Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present).
Intervention Type
Device
Intervention Name(s)
Urinary catheter
Intervention Description
Urinary cytology will be collected through a Ch14 urinary catheter after the cystoscopy
Primary Outcome Measure Information:
Title
The quality of urinary cytology according to the tool used for collection of both groups
Description
Number of urothelial cells, number of inflammatory cells, presence of necrosis or blood will be used to assess this outcome measure
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The sensitivity and sensibility of the urinary cytology of both groups
Description
Sensitivity ans specificity percentage will be calculated based on the results of both urinary cytology and cystoscopy
Time Frame
2 years
Title
The satisfaction of patients of both groups
Description
The Faces Pain Scale will be used for each patient after the cytology to assess his satisfaction/pain (0= no pain and 10=the worst pain possible)
Time Frame
2 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men aged > or = 18 years Patients scheduled for a flexible cystoscopy and urinary cytology. Patients who have signed the informed consent. Patients who speak French Exclusion Criteria: Manipulations or instrumentation of urinary tract, including but not limited to Double-J stent placement or removal, and/or bladder biopsy Inability to give informed consent or without capacity of discernment
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois, CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilaria Lucca, MD
Phone
+41213141111
Email
ilaria.lucca@chuv.ch
First Name & Middle Initial & Last Name & Degree
François Crettenand, MD
Phone
+41213141111
Email
francois.crettenand@chuv.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better?

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