Reduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 350
- 主要终点
- Rate of post-operative urinary retention (POUR)
研究概览
简要总结
The purpose of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing thoracic surgery.
详细描述
Post-operative urinary retention (POUR) is not an uncommon complication following thoracic surgery. It has been reported to occur in up to 12-67% of patients with the use of thoracic epidural analgesia1. Risk factors associated with urinary retention in thoracic patients include male, age over 40 years, type 2 diabetes, undergoing lung resection and the use of thoracic epidural analgesia2. Patients who experience urinary retention are treated with a straight catheter and may subsequently require the placement of an indwelling catheter. The use of these catheters is associated with numerous complications. The best studied complications are infectious and include catheter associated urinary tract infections (CAUTIs). However, many patients continue to experience symptoms well after their catheters have been removed.
Tamsulosin is an alpha one adrenergic receptor blocked that is indicated for the treatment of lower urinary tract symptoms in the context of benign prostatic hyperplasia. However, it is often used in clinical practice to treat other pathologies such as acute urinary retention and nephrolithiasis.
The objectives of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and catheter related complications in people undergoing thoracic surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients greater than the age of 40 and/or with type 2 diabetes undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively.
- •Male patients receiving a thoracic epidural analgesia undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively
排除标准
- •Active treatment of Benign Prostatic Hyperplasia (BPH)
- •Hypersensitivity or allergy to tamsulosin HCL
- •Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date
- •Active urinary tract infection
- •History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy
- •History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy)
- •Underlying neurological disorders resulting in impaired bladder function
- •Any known contraindication to the use of tamsulosin HCL
研究组 & 干预措施
Tamsulosin Hydrochloride (HCL)
Consenting patients undergoing pulmonary resection will receive a 5-day allotment of tamsulosin HCL to be started 3 days prior to their date of surgery.
干预措施: Tamsulosin Hydrochloride (Drug)
Placebo
Consenting patients undergoing pulmonary resection will receive a 5-day allotment of placebo to be started 3 days prior to their date of surgery.
干预措施: Placebos (Drug)
结局指标
主要结局
Rate of post-operative urinary retention (POUR)
时间窗: 0-24 hours
Rate of POUR; defined as requiring straight or indwelling catheterization at any point in the post-operative period.
次要结局
- Duration of hospital length of stay(0 to 365 days)
- Time to first catheterization(0-24 hours)
- Treatment emergent Adverse Events(-3 days to 2 days)
- Rates of catheter complications within 30 days of catheterization(0 to 30 days)
- Rate and number of straight catheterizations(0-7 days)
- Rate of indwelling catheterization(0-7 days)