NCT02684344终止不适用
Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants With Post-operative Urinary Retention
研究概览
简要总结
This randomized open-label study will be comprised of 2 cohorts: one control group and one treatment group. The trial will be conducted as an open label randomized trial to evaluate the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study will include pre- and post-surgical evaluations of patients including symptoms of urinary retention and any adverse effects contributable to the study medication.
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
- None
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
- •Any male age 40 or older
- •Scheduled to undergo one of the planned surgeries (thoracic, general, or urologic)
- •Ability to give informed consent
排除标准
- •Current use of alpha blocker
- •Current use of a strong CYP 3A4 inhibitors
- •Any allergy to tamsulosin, alpha-blocker medication class, or anaphylaxis allergy to sulfate containing medications
- •Patients with any upcoming surgery for cataracts
- •Currently enrolled in a clinical trial
- •Inability to give informed consent
研究组 & 干预措施
Tamsulosin Group
Experimental
Subjects will receive:
- 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery
- education about signs and symptoms of urinary retention
干预措施: Tamsulosin (Drug)
Tamsulosin Group
Experimental
Subjects will receive:
- 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery
- education about signs and symptoms of urinary retention
干预措施: Education (Other)
Education Group
Active Comparator
Subjects will receive:
- education about signs and symptoms of urinary retention
干预措施: Education (Other)
结局指标
主要结局
Number of Participants With Post-operative Urinary Retention
时间窗: 5 days
次要结局
未报告次要终点
研究者
Edward Messing
Principal Investigator
University of Rochester
研究点 (1)
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