Post-operative Urinary Retention (POUR) Following Thoracic Surgery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Volume of urine (cc) post thoracic surgery in patients that received Flomax, 0.4mg/day for a week before surgery
研究概览
简要总结
Inability to urinate a common complication that happens to many patients after a surgery, especially in men over 60 years of age who undergo surgery on their chest. Urinary retention is uncomfortable, increases anxiety, increases hospital length of stay, and leads to more procedures such as putting in a bladder catheter (Foley). This is uncomfortable, and can lead to bleeding, infection, damage to the urethra and/or bladder and bladder spasm. The goal of this study is to attempt to prevent inability to urinate by giving patients a medication called Flomax (Tamusolin) every day beginning a week before surgery. That medication relaxes the prostate. It's approved by the Food and Drug Administration (FDA) to improve urinary flow in those with enlarged prostates. It is also commonly used in patients with bladder problems due to inability to urinate who have required a Foley.
详细描述
Post-operative urinary retention (POUR) in older men who undergo a thoracic surgical procedure occurs in a significant proportion of patients (25% at Hackensack University Medical Center in men >60) and is a significant management problem. Typically, this complication needs to be treated with placement of a bladder catheter (foley). In addition to the discomfort of placing a foley in an awake patient, these patients are at a significantly increased risk of a catheter associated urinary tract infection (CAUTI), potential genito-urinary injury during the placement, and bladder muscle damage due to distention.
The goal of this study is to investigate whether the use of Tamusolin could lower the high incidence of POUR in older men undergoing a thoracic surgical procedure.
The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 1 week), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •≥50 years old Planned surgical procedure of a minimally invasive thoracic surgical procedure (wedge resection, segmentectomy, lobectomy, pleural biopsy, or pleurodesis) Surgery scheduled more than 3 days from the time of consent
排除标准
- •Using Flomax already
- •Allergy to Flomax or sulfa drugs
- •Current use of alpha blockers or alpha agonists
- •Resting systolic blood pressure <100
- •Orthostatic hypotension of >20mm Hg (millimeters of mercury) Systolic and/or 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent
- •Known diagnosis of congestive heart failure and valvular heart disease
- •History of prostate surgery (prostatectomy, trans-urethral resection)
研究组 & 干预措施
3 days Pre-operative Tamsulosin administration
干预措施: Tamsulosin - 3 days (Drug)
1 week Pre-operative Tamsulosin administration
干预措施: Tamsulosin - 1 week (Drug)
结局指标
主要结局
Volume of urine (cc) post thoracic surgery in patients that received Flomax, 0.4mg/day for a week before surgery
时间窗: 8 hours
The absence of voiding naturally after undergoing thoracic surgery needing an intervention as a Foley catheter or a catheterization. Documentation for first void, Post bladder scan showing more that 300cc of residual urine in the bladder (failure to urinate), or following spontaneous urination if there is more than 300cc of residual urine in the bladder (inadequate urination)
次要结局
未报告次要终点