Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 7
- 主要终点
- Number of participants who develop postoperative urinary retention (POUR) postoperatively (efficacy).
研究概览
简要总结
This study is being done to answer the question: What is the impact of a medication called tamsulosin (also called Flomax) on the rate of postoperative urinary retention (POUR) and catheter-associated urinary tract infection (UTI)? One of the most common complications following surgery and associated with Foley catheters is post-operative urinary retention (POUR) after the catheter is removed. This is defined as being unable to urinate spontaneously within 8 hours following the removal of the indwelling Foley catheter (the catheter that sits in your bladder to drain urine after surgery). When this happens, it requires intermittent straight catheterization of the bladder (placing a temporary catheter in the bladder to drain the buildup of urine), which can cause a lot of discomfort and anxiety, as well as increase the risk of catheter-associated urinary tract infection (CAUTI).
详细描述
All participants in this study will be males who are undergoing a planned surgery on their liver, gallbladder/biliary tract, pancreas, colon, or rectum for any reason. If able to obtain appropriate consent from a legal representative, cognitively impaired patients may be included. After having surgery where a catheter is placed in the bladder to drain urine (this is called a Foley indwelling catheter), the catheter eventually gets removed, and some of the most frequent problems that can happen after that are post-operative urinary retention (POUR) and catheter-associated urinary tract infection (CAUTI).
The goal of this study is to see if a medicine called tamsulosin (also called Flomax) can decrease the rate of POUR, which means not being able to urinate spontaneously like normal, and CAUTI, which means an infection in the urinary tract. This study is important because POUR and CAUTI can cause harm to patients, including discomfort if a temporary catheter has to be placed back in the bladder to get the urine out, infection, anxiety, and stress, and it's known that these complications can also increase hospital charges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Planned for elective surgery for any reason (benign, malignant, or indeterminate lesion) with either an open or minimally invasive approach (hepatobiliary, pancreatic, and colorectal operations)
- •Male and age ≥50 years
- •Deemed physically fit for surgery
排除标准
- •Inability to obtain informed consent
- •Age <50 years
- •Baseline creatinine >1.5x upper limit of normal
- •Tamsulosin therapy as a home-medication
- •Procedure involving the prostate, bladder, ureters, or kidneys
- •Planned Foley catheter removal on the same day of surgery
- •Planned nasogastric tube retention on postoperative day 1
- •Individuals taking daily phosphodiesterase 5 (PDE5) inhibitors (due to the risk of symptomatic hypotension if given with tamsulosin)
研究组 & 干预措施
Control Group
Participants will be randomized to the standard of care, with no medication given.
干预措施: Control Group (Other)
Tamusolin
Participants will receive tamsulosin postoperatively for two days.
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Number of participants who develop postoperative urinary retention (POUR) postoperatively (efficacy).
时间窗: Up to 3 days post-surgery
Researchers will document the incidence of postoperative urinary retention (POUR) rate, as defined as the inability to void within 8 hours after Foley catheter removal at midnight on postoperative day 1.
次要结局
- Number of participants with catheter-associated urinary tract infections (CAUTI),(Up to 5 days post-surgery)
研究者
Kenneth Cardona
Professor of Surgery
Emory University