Trial of Void With Saline Bladder Instillation, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Time from catheter removal to determination of passing void trial
研究概览
简要总结
This study is being done to see if there is a difference between the traditional method of removing a urethral catheter after surgery and waiting for the patient to urinate on their own to the saline instillation method which places either room temperature or warmed saline into the patient's bladder through the catheter before removing the catheter.
详细描述
Voiding trials after surgery to remove a catheter can be done in different ways.
Traditional method: The catheter is removed and the patient will attempt to void.
Room temperature saline instillation: Room temperature saline will be placed in the patients bladder through the catheter. The catheter will be removed and the patient will attempt to void.
Warmed saline group: Saline that has been warmed to 37C will be placed in the patients bladder through the catheter. The catheter will be removed and the patient will attempt to void.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing trial of void after placement of indwelling urethral catheter after urologic procedure
排除标准
- •Patient incontinent at baseline.
- •Patient has chronic indwelling urinary catheter or uses clean intermittent catheterization at home.
- •Patient has documented neurogenic bladder.
- •No trained person to administer the instillation or perform consent.
- •Patient refusal to participate.
- •Patient unable to give informed consent.
- •Patient is a prisoner.
- •Patient is pregnant.
- •Patient unable to participate in notifying nursing of voids.
- •Nursing is unable to measure post void residual with bladder scan machine secondary to body habitus or other anatomical abnormality.
研究组 & 干预措施
Standard of care group
No saline instillation
干预措施: No saline instillation (Procedure)
Room temperature saline group
room temperature saline instillation
干预措施: Room temperature saline instillation (Procedure)
Warmed saline group
warmed saline instillation
干预措施: Warmed saline instillation (Procedure)
结局指标
主要结局
Time from catheter removal to determination of passing void trial
时间窗: 6 hours
The time from when the urinary catheter is removed to a successful voiding trial defined as Void of at least 100ml AND Post Void residual (PVR) \<150 or \<2/3 of the voided volume
次要结局
- Catheter free rate(30 days)
- Urinary tract infection free rate(30 days)
- Post void residual (PVR)(Within 30 days)
研究者
Ronald Kaufman, MD
Associate Professor of Surgery
Albany Medical College