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

NCT ID: NCT05643807

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 414 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-08
• Study Completion Date: 2024-11-30

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).

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

urinary catheter

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 Type: ACTIVE_COMPARATOR

Urinary catheter

Intervention Type: DEVICE

Urinary cytology will be collected through a Ch14 urinary catheter after the cystoscopy

flexible cystoscope

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).

Group Type: ACTIVE_COMPARATOR

Flexible cystoscopy

Intervention Type: DEVICE

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).

Interventions

Flexible cystoscopy

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

Urinary catheter

Urinary cytology will be collected through a Ch14 urinary catheter after the cystoscopy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Men aged > or = 18 years

2. Patients scheduled for a flexible cystoscopy and urinary cytology.

3. Patients who have signed the informed consent.

4. Patients who speak French

Exclusion Criteria

1. Manipulations or instrumentation of urinary tract, including but not limited to Double-J stent placement or removal, and/or bladder biopsy

2. Inability to give informed consent or without capacity of discernment

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Ilaria Lucca

Principal investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre Hospitalier Universitaire Vaudois, CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Facility Contacts

Ilaria Lucca, MD

Role: primary

ilaria.lucca@chuv.ch

+41213141111

François Crettenand, MD

Role: backup

francois.crettenand@chuv.ch

+41213141111

Other Identifiers

2021-01124

Identifier Type: -

Identifier Source: org_study_id