NCT01209988Unknown不适用
A Prospective Randomized Study Examining the Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-Assisted Laparoscopic Radical Prostatectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The incidence of acute urinary retention
研究概览
简要总结
To date, there is a lack of consensus concerning the optimal timing for removal of the urethral catheter, its related complications, the effectiveness in prophylactic drug use to reduce complication, and the patient reported outcomes (quality of life) after robot-assisted laparoscopic prostatectomy (RALP). The purpose of this study is to determine the impact of tamsulosin on voiding patterns following early urethral catheter removal after RALP for prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must have localized or locally advanced prostate cancer
- •Patients must receive robot assisted laparoscopic radical prostatectomy
- •Patients must be able to provide written informed consent
排除标准
- •Patients must not have a history of treatment with alpha blockers within 4 weeks
- •Patients must not have previously undergone transurethral resection, laser therapy, or other surgery of the prostate
- •Patients must not have previously been diagnosed with neurogenic bladder
- •Patients must not have hypersensitivity to trial drug or other alpha-blockers
- •Patients must not have the participation of other clinical trial within the past 3 months
研究组 & 干预措施
Tamsulosin 0.4mg
Experimental
Perioperative tamsulosin 0.4mg daily
干预措施: tamsulosin 0.4mg (Drug)
Control
Placebo Comparator
No medication
干预措施: No medication (Other)
结局指标
主要结局
The incidence of acute urinary retention
时间窗: within the 30 days after surgery
次要结局
- Patient reported outcomes(20 days after surgery (plus or minus 3 days))
研究者
研究点 (1)
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