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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05643807

Studienbeginn:
Februar 2023

Letztes Update:
10.02.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Centre Hospitalier Universitaire Vaudois

Collaborator:
-

Studienlocations
(1 von 1)

Centre Hospitalier Universitaire Vaudois, CHUV
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Ilaria Lucca, MD
Phone: +41213141111
E-Mail: ilaria.lucca@chuv.ch

François Crettenand, MD
Phone: +41213141111
E-Mail: francois.crettenand@chuv.ch» Ansprechpartner anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. The quality of urinary cytology according to the tool used for collection of both groups (Time Frame - 2 years):
Number of urothelial cells, number of inflammatory cells, presence of necrosis or blood will be used to assess this outcome measure

Secondary outcome:

1. The sensitivity and sensibility of the urinary cytology of both groups (Time Frame - 2 years):
Sensitivity ans specificity percentage will be calculated based on the results of both urinary cytology and cystoscopy

2. The satisfaction of patients of both groups (Time Frame - 2 years):
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)

Studien-Arme

Active Comparator: 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.
Active Comparator: 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).

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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