Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Participants With Post-Operative Urinary Retention (Pour)
研究概览
简要总结
Post-Operative Urinary Retention (POUR) in Thoracic Surgery is a prospective interventional study aiming to test the hypothesis that the prophylactic use of tamsulosin prior to thoracic surgery in high risk patients leads to reduce the rates of POUR.
详细描述
Post-operative urinary retention (POUR) is one of the most common post-operative complications encountered by most surgical specialties. The incidence of POUR can vary from five to 70%.
Post-operative urinary retention is a prevalent complication. Patients who undergo thoracic surgery have greater urinary retention rates compared to others. Data on effective methods to reduce the risk of POUR in this high-risk group are limited.
All subjects who meet inclusion and exclusion criteria will be invited to participate. There will be no randomization. All will receive tamsulosin in the pre operative period.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All male patients >=60 years old who undergo inpatient thoracic surgery for major resections.
排除标准
- •- Prisoners
- •Adults unable to consent
- •End stage renal disease on hemodialysis
- •Indwelling urinary catheter
- •Child-Pugh class C hepatic failure
- •Usage of the following medications prior to surgery: strong CYP 3A4 inhibitors, strong CYP2D6 inhibitors, other alpha-adrenergic blocking agents, PDE5 inhibitors, and cimetidine
- •patients known to be CYP2D6 poor metabolizers
- •History of prostatectomy or cystectomy
- •Patients with contraindications to tamsulosin and those at high risk for side effects: hypersensitivity to tamsulosin HCl or any component of FLOMAX capsules, hypersensitivity to sulfonamides. History of known glaucoma, hypotension, plan to undergo cataract surgery in the next 2 weeks
研究组 & 干预措施
Perioperative Tamsulosin Hydrochloride
Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery.
干预措施: Tamsulosin Hydrochloride (Drug)
结局指标
主要结局
Participants With Post-Operative Urinary Retention (Pour)
时间窗: 5 days
Proportion of Participants experiencing Post-Operative Urinary Retention (POUR) following thoracic surgery as compared to historic controls.
次要结局
未报告次要终点