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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better? A Prospective Randomized Study

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: Flexible cystoscopy
* Device: Urinary catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: urinary catheter<br>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. | Device: Urinary catheter<br>* Urinary cytology will be collected through a Ch14 urinary catheter after the cystoscopy<br>|
| Active Comparator: flexible cystoscope<br>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). | Device: Flexible cystoscopy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 
| 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) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder cancer, Urinary cytology