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临床试验/NCT02958878
NCT02958878已完成4 期

Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair

Ascension Health0 个研究点目标入组 210 人开始时间: 2017年1月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
210
主要终点
number of Urinary Retention

研究概览

简要总结

Double blinded, randomized controlled prospective study looking at 2 preoperative doses of Tamsulosin an alpha-adrenergic blocker in preventing post-operative urinary retention. A previous study was conducted called "Effectiveness of tamsulosin inprevention of postoperative urinary retention: a randomized double-blind-placebo controlled study" This study involved a tertiary care center involving mostly urological surgical procedures. We look to specifically look at inguinal hernia surgeries in males. The aim of this study is to compare the prophylactic effect of tamsulosin with placebo on postoperative urinary retention. The drug is FDA approved for benign prostatic hypertrophy and urinary retention. It is on formulary at Genesys. Currently there is no standard procedure of prophylactic tamsulosin for urinary retention. Most often post operative patients are given tamsulosin to augment smooth muscle relaxation and spontaneous voiding if the patient is having urinary retention post operatively. We often straight catheterize patients once and start tamsulosin with the goal of avoiding urinary retention and future straight catheterizations or placement of foley catheters

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
30 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy males, who are not taking Tamsulosin regularly who are undergoing elective inguinal hernia repair (laparoscopic, open, and robotic assisted)

排除标准

  • Patients who are already taking tamsulosin, terazosin (alpha blocker treatement for BPH) , finasteride, dutasteride ( both 5 alpha reductase inhibitors), sulfa allergy, and lactose allergy

研究组 & 干预措施

A

Experimental

Tamsulosin 0.4mg given the night before surgery and another dose the day of surgery in the morning.

干预措施: Tamsulosin (Drug)

B

Placebo Comparator

Placebo medication given the night before surgery and another dose the day of surgery in the morning

干预措施: Placebo Oral Capsule (Drug)

结局指标

主要结局

number of Urinary Retention

时间窗: within 72 hours of surgery

If patients have urinary retention post operatively

次要结局

  • placebo vs tamsulosin(within 72 hours of surgery)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Anthony Tabatabai

General Surgery Resident

Ascension Health

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