Identification of Urinary Retention by Simplified Ultrasound: Diagnostic Without Volumetric Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Diagnostic performance of simplified ultrasound
研究概览
简要总结
Urinary retention is a urological emergency that requires prompt management to prevent complications such as acute kidney injury or bladder rupture. Currently, diagnosis is based on clinical examination, sometimes supplemented by a bladder scanner (a device used to measure bladder volume) or by a more detailed ultrasound examination with measurement of bladder volume. A bladder volume greater than 400 mL (urinary bladder distension), combined with anuria, dysuria, or suprapubic pain, is diagnostic of urinary retention.
The aim of this prospective study protocol is to determine whether simple visualization of the bladder using an ultrasound probe placed between the umbilicus and the pubic bone, performed by trained nurses, can reliably diagnose urinary bladder distension (bladder volume greater than 400 mL). If this hypothesis is confirmed, this approach could enable a simple and rapid diagnosis, thereby facilitating earlier treatment of bladder distension secondary to urinary retention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers
- •Informed consent read and signed by the healthy volunteer
排除标准
- •Healthy volunteer refusing to undergo the ultrasound.
- •Performance of the suprapubic ultrasound is impossible.
- •Healthy volunteer unable to understand any of the languages used for the consent process.
研究组 & 干预措施
Bladder ultrasound
The investigator nurse will place an ultrasound probe in the suprapubic position, transversely and perpendicular to the skin, in the healthy volunteer. Simple visualization of the bladder will be recorded as either visible or not visible. The investigator nurse will then assess whether the examination is considered easy or difficult.
A measurement of bladder volume (width, length, and height) will subsequently be performed by a physician investigator trained in ultrasound.
The healthy volunteer will then urinate into a graduated container. An ultrasound examination will be performed again to assess whether any post-void residual urine volume is present.
干预措施: Bladder ultrasound (Diagnostic Test)
结局指标
主要结局
Diagnostic performance of simplified ultrasound
时间窗: 10 minutes
The primary objective of this study is to measure bladder volume in healthy volunteers using simplified ultrasound performed by nurses, in order to evaluate the diagnostic performance of bladder ultrasound. Bladder distension (volume ranging from 300 cc to \>500 cc) is a sign of urinary retention. Diagnosis typically relies on comprehensive volumetric bladder ultrasound performed by physicians. In the absence of volumetric ultrasound, if urinary retention is suspected, urinary catheterization (an invasive procedure) is sometimes performed "blindly" for diagnostic purposes to allow for urine drainage. In this context, simplified bladder ultrasound performed by nurses could reduce diagnostic time and patient discomfort.
次要结局
- Ultrasound reproducibility(10 minutes)
- Ease of performing the ultrasound(10 minutes)
- Bladder volume versus urine volume(10 minutes)