跳至主要内容
临床试验/NCT03801720
NCT03801720终止不适用

UltraWee: Ultrasound Bladder Stimulation to Help With Clean Catch Urine in Pre-Continent Children

State University of New York - Upstate Medical University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
4
试验地点
2
主要终点
Incidence of miturition

研究概览

简要总结

The UltraWee study is a prospective randomized controlled trial used to compare the success rate of and time to obtaining a urine sample in pre-continent children between standard clean catch urine (CCU) method and using ultrasound stimulation clean catch methods. The objectives of this study are to see if ultrasound stimulation increases success rate of micturition, decreases time to micturition, and decreases the use of more invasive techniques for urine collection.

详细描述

Standard procedure for obtaining urine samples in the pediatrics emergency department consists of a clean catch urine (CCU). For those patients who are still pre-continent, this involves cleaning the genitourinary (GU) area with betadine followed with waiting with a specimen cup for the patient to produce urine.

Currently, the CCU technique has had mixed success rates of micturition, some studies showing as low as 12% success rate. Because of the mixed success rates, often times these patients are subjected to the discomfort and trauma of a urinary catheter. Catheterization also occurs in patients with clinical conditions that require urine samples under time sensitive conditions.

Less invasive ways of urine collections have been recently studied. The Quick-Wee study was a novel study that showed a promising alternative to obtaining urine samples in pre-continent children when compared to the CCU sample. This method served as a noninvasive way to obtain a urine sample, thus preventing uncomfortable and traumatic urinary catheterizations and improving parent satisfaction scores.

The investigators hope to study the effectiveness of another technique for obtaining a urine sample without urinary catheterization: ultrasound stimulation. By incorporating ultrasound evaluation of the bladder, the UltraWee study hopes to decrease the number of failed attempts at obtaining a urine sample in pre-continent children less than thirty-six months of age.

The UltraWee study will be a prospective randomized controlled trial comparing success rate of and time to obtaining a urine sample in pre-continent children between standard clean catch urine method and using ultrasound stimulation clean catch methods. The objective of this study is to see if ultrasound stimulation increases success rate and decreases time to micturition.

研究设计

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

入排标准

年龄范围
1 Month 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Pre-continent children
  • Children between the ages of 1 month and 36 months
  • Children who require a urine sample as part of their workup
  • Children who are seen in the emergency department at University Hospital Downtown Campus

排除标准

  • Children who are continent
  • Children who are in foster care or who are wards of the state

结局指标

主要结局

Incidence of miturition

时间窗: Less than 5 minutes

Recorded act of successfully initiating miturition/urination

Time to Miturition

时间窗: 0-5 minutes

Recorded time to miturition

次要结局

未报告次要终点

研究者

发起方
State University of New York - Upstate Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vincent Calleo

Principal Investigator

State University of New York - Upstate Medical University

研究点 (2)

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UltraWee: Ultrasound Bladder Stimulation | 临床试验