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临床试验/NCT03108079
NCT03108079Unknown不适用

Bladder Morphology Using 2 Different Catheter Designs Foley Catheter vs. Cystosure Urinary Access System

The Pelvic Floor Institute2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3
试验地点
2
主要终点
Bladder shape after emptying

研究概览

简要总结

Demonstrate and compare the 3D morphology of the bladder wall in full and drained states with 2 different kinds of bladder catheters in place. (Foley Catheter vs. Cystosure Catheter)

详细描述

The Foley catheter has been the mainstay of bladder drainage for many decades. There has been little design change despite risks associated with Foley catheter use including cather associated Urinary Tract Infections(UTIs). However, recent incentives and penalties related to iatrogenic bladder infections have encouraged healthcare providers to search for ways to decrease catheter-associated infections. Data suggests that the design of the traditional Foley catheter may be responsible for bladder mucosal injury due to contact with the drainage tip, which in turn contribute to bladder infections associated with long term indwelling Foley catheter usage. The Cystosure catheter is an FDA approved bladder drainage device, with a shortened drainage port, designed to avoid contact with the bladder mucosa. It is postulated that the lack of contact with the mucosa would decrease mucosal injury, possibly leading to decreased incidence of catheter related bladder infections. Early sheep bladder microscopy studies have suggested that the Cystosure catheter produces significantly less mucosal injury compared to the Foley catheter following a short period of indwelling bladder catheterization. The present study is designed to compare bladder wall geometry around the drainage balloon in the Foley versus the Cystosure drainage catheters in living women. It is hypothesized that the "tip-less" cystosure catheter will have a smoother, more continuous bladder contour around the drainage port, compared to the traditional Foley catheter tip.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pelvic Floor Institute patients aged between 21 and 70 years of age, who are able to speak and understand English, who are not currently pregnant, or had a pregnancy in the previous 6 months.

排除标准

  • Women with claustrophobia or any contraindication to undergoing an MRI scan will be excluded. Similarly, women with hip, knee, or shoulder replacements will be excluded because of the need for urethral catheterization. Women with significant mitral valve prolapse will also be excluded for the same reason. Women with history of 3 or more culture-documented UTIs over the last 12 months will be excluded. Women who are unable or unwilling to give informed consent will also be excluded. Women who are unable to tolerate 300 cc of fluid in the bladder will be excluded. Women with a nitrite-positive urinalysis at the time of study enrollment will be excluded until they can demonstrate a negative urine culture.

结局指标

主要结局

Bladder shape after emptying

时间窗: 1 month

Bladder shape after emptying using both catheters will be assessed. The 3D reconstructed images will be compared to determine if there are any differences in bladder shape in full and empty states between the 2 catheter types.

次要结局

未报告次要终点

研究者

发起方
The Pelvic Floor Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lennox Hoyte, MD

Principal Investigator

The Pelvic Floor Institute

研究点 (2)

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