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临床试验/NCT02919436
NCT02919436已完成4 期

Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

Anand Rughani, MD1 个研究点 分布在 1 个国家目标入组 610 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
610
试验地点
1
主要终点
Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention

研究概览

简要总结

Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.

详细描述

Postoperative urinary retention (POUR) is a common complication following certain surgical operations. While much is known about the innervation and neural regulation of bladder emptying and storage, the cause of urinary retention after surgery is not fully understood. Early research has indicated that a small dose of tamsulosin (Flomax®), a commonly used medication approved to treat urinary symptoms in men with benign prostatic hypertrophy, may reduce the incidence of POUR. Urinary retention is a prevalent issue in patients undergoing spinal surgery, leading to patient discomfort and prolonged length of stay. We hypothesize that the use of perioperative tamsulosin in patients undergoing spinal surgery will decrease the incidence of POUR.

The study is a prospective, double-blind, randomized, placebo-controlled trial. Subjects will be randomized 1:1 to receive either oral tamsulosin 0.4 mg or placebo, taken once each evening, beginning 5 days prior to surgery and continuing through the first postoperative day. The primary endpoint is met when the patient is able to spontaneously empty their bladder post-operatively, or needs to be catheterized with either a straight or indwelling urinary catheter for post-operative urinary retention, whichever occurs first.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Currently on tamsulosin or other alpha-adrenergic blocking drug
  • Allergy to tamsulosin
  • Allergy to lactose
  • Serious or life-threatening allergy to sulfa drugs
  • Emergent procedure
  • History of spinal trauma, spinal infection or spinal cord tumor
  • Pre-existing indwelling urinary catheter
  • History of orthostatic hypotension or current orthostatic hypotension
  • History of prostate, urethral or bladder surgery
  • Renal failure
  • Non-English speaking
  • Unable to provide informed consent

研究组 & 干预措施

Tamsulosin

Experimental

Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery.

干预措施: Tamsulosin (Drug)

Placebo

Placebo Comparator

Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery.

干预措施: Placebo (Drug)

结局指标

主要结局

Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention

时间窗: Within 2 days after surgery

Postoperative urinary retention was defined as the need for any postoperative urinary catheterization for acute retention. Per hospital protocol, failure to void 6 hours after surgery or development of bladder discomfort required bladder scan. If bladder volume exceeded 300 cc, catheterization was performed.

次要结局

  • Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual(Within 2 days after surgery)
  • Length of Stay(0-7 days after surgery)

研究者

发起方
Anand Rughani, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anand Rughani, MD

Neurosurgeon

MaineHealth

研究点 (1)

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