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

NCT05643807 | Unknown DMC

• 1 other identifier: 2021-01124
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Bladder cancer; Urinary cytology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The sensitivity and sensibility of the urinary cytology of both groups

  2 years

• The satisfaction of patients of both groups

  2 years

Study Arms (2)

urinary catheter

ACTIVE COMPARATOR

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

flexible cystoscope

ACTIVE COMPARATOR

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

Interventions

Flexible cystoscopy 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).

flexible cystoscope

Urinary catheter DEVICE

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

urinary catheter

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois, CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Urinary Catheters

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 9, 2022
• Study Start: February 8, 2023
• Primary Completion: June 1, 2024
• Study Completion: November 30, 2024
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

CH (1)