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临床试验/NCT05643807
NCT05643807招募中不适用

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

Centre Hospitalier Universitaire Vaudois1 个研究点 分布在 1 个国家目标入组 414 人开始时间: 2023年2月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
414
试验地点
1
主要终点
The quality of urinary cytology according to the tool used for collection of both groups

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Urinary catheter (Device)

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).

干预措施: Flexible cystoscopy (Device)

结局指标

主要结局

The quality of urinary cytology according to the tool used for collection of both groups

时间窗: 2 years

Number of urothelial cells, number of inflammatory cells, presence of necrosis or blood will be used to assess this outcome measure

次要结局

  • The sensitivity and sensibility of the urinary cytology of both groups(2 years)
  • The satisfaction of patients of both groups(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilaria Lucca

Principal investigator, MD

Centre Hospitalier Universitaire Vaudois

研究点 (1)

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