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临床试验/NCT00324233
NCT00324233已完成不适用

Evaluation of Residual Urine After Intermittent Catheterisation - Comparison of 2 Hydrophilic Coated, Intermittent Catheters

Coloplast A/S1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2006年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Coloplast A/S
入组人数
36
试验地点
1
主要终点
Residual Urine Measured by Ultra Sound

研究概览

简要总结

Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
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
是

入选标准

  • •18 years and above
  • •A negative urine dip-stick
  • •Have signed informed written consent to participate

排除标准

  • •The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract

研究组 & 干预措施

SC

Active Comparator

Speedicath (SC) catheter is a catheter for intermittent catherisation

干预措施: Intermittent catheter (Device)

SCCM

Experimental

SpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males

干预措施: Compact intermittent catheter (Device)

结局指标

主要结局

Residual Urine Measured by Ultra Sound

时间窗: 2

次要结局

  • Subjectively Measured Handling
  • Subjectively Measured Insertion of the Catheter

研究者

发起方
Coloplast A/S
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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