Effect of Active vs. Passive Voiding Trials on Time to Patient Discharge, Rate of Urinary Tract Infection, and Rate of Urinary Retention: a Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 274
- 主要终点
- time from removal of Foley catheter until hospital discharge
研究概览
简要总结
Urinary retention is a common problem, particularly in hospitalized patients. When a Foley catheter is removed, a patient must be monitored for urinary retention. The usual method is a passive voiding trial where the catheter is removed, the bladder fills with urine and the patient is monitored for voiding over approximately 6 hours. Another option is an active voiding trial where the bladder is filled with saline before the catheter is removed and the patient is immediately assisted to void. This study seeks to determine the effect of active vs passive voiding trials on time to hospital discharge, rate of urinary tract infections, and rate or urinary retention in the general hospitalized population.
详细描述
The intervention to be tested is an active voiding trial, where the bladder is filled with saline before the catheter is removed and the patient is immediately assisted 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
- Treatment
- 盲法
- Single (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
- •Admission to one of three hospital units at the University of Virginia (5 Central, 6 West, or the Short Stay Unit)
- •Patient has a Foley urethral catheter in place
- •The physician has ordered the Foley urethral catheter to be discontinued
- •18 years of age and older
排除标准
- •Age less than 18 years
- •Prisoners
- •Women who are pregnant
研究组 & 干预措施
Active Voiding Trial (instillation of sterile saline)
Patients randomized to receive an active voiding trial will have the bladder filled with 250-400 cc of sterile saline (or until the bladder was full) via the lumen of the urinary catheter before the urinary catheter is removed. The patient will then be immediately assisted to void. Physician teams will follow a standardized algorithm for the management of urinary retention arising during the study.
干预措施: Active Voiding Trial (Procedure)
Passive Voiding Trial
For patients randomized to receive a passive voiding trial, the urinary catheter will be removed, the bladder will fill with urine naturally, and the patient will be assisted to void when he or she reports the urge. To ensure uniformity in the intervention, all voiding trials in the study will be supervised by an experienced nurse who will ensure that the protocol is followed.
干预措施: Passive Voiding Trial (Procedure)
结局指标
主要结局
time from removal of Foley catheter until hospital discharge
时间窗: approximately one day
time from removal of the Foley catheter until the patient physically leaves the hospital
次要结局
- Urinary retention(within 2 weeks of hospital discharge)
- urinary tract infection(within 2 weeks of hospital discharge)
研究者
Tracey Krupski, MD
Vice Chair
University of Virginia