Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Number of Patients to Develop Postoperative Urinary Retention (POUR)
研究概览
简要总结
The study aims to evaluate the efficacy of prophylactic tamsulosin in reducing the incidence of postoperative urinary retention in primary total knee and hip arthroplasty patients.
详细描述
Prophylactic administration of tamsulosin will be compared to a placebo to evaluate the effectiveness in reducing the incidence of postoperative urinary retention in total hip and knee arthroplasty patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men age 35 or older
- •Primary total hip and knee arthroplasty patients (general, spinal, or epidural anesthesia
- •No current use (>1 month) of alpha-blockers
- •Community ambulator
- •Adequate organ and marrow function as defined below:
- •leucocytes at least 3,000/µL, absolute neutrophil count at least 1,500/µL, platelets at least 100,000/µL, creatinine within normal institutional limits
- •Ability to understand, and the willingness to sign, a written informed consent
排除标准
- •History of radical prostatectomy
- •Receiving any other investigational agents
- •Revision hip and knee arthroplasty patients
- •Severe liver or kidney disease
- •Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)
- •Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin)
- •Being of 5-alpha reductase inhibitors (finasteride, dutasteride)
- •History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine)
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Taking Sildenafil,Tadalafil, or Vardenafil
研究组 & 干预措施
tamsulosin
0.4 mg daily for five days pre-op through post-op day one (seven total)
干预措施: Tamsulosin (Drug)
placebo
One capsule daily for five days pre-op through post-op day one (seven total)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Patients to Develop Postoperative Urinary Retention (POUR)
时间窗: Postop day 1
Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery.
次要结局
- Length of Hospital Stay(1-4 days postoperative)
- Incidence of Discharge to a Skilled Nursing Facility(1-4 days postoperative)
- Incidence of Surgical Site Infection(Up to two weeks postoperative)
- Acute Postoperative Pain Medication Dosages(Postoperative day 1 to day of discharge (1-4 days on average))
- Incidence of Postoperative Complications(Up to 31 days postoperative)
研究者
Andrew Urquhart
Associate Professor of Orthopaedic Surgery
University of Michigan