NCT00478998Unknown2 期
Phase II Study Comparing Two Groups of Patients Undergoing ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin
适应症
相关药物
试验速览
- 阶段
- 2 期
- 试验地点
- 1
- 主要终点
- stone status at 3 month .
研究概览
简要总结
The purpose of this study is to see whether patients undergoing ESWL, for upper tract urinary stones between 1.5-2.0cm, may be treated by expulsion therapy(Tamsulosin) instead of inserting ureteral stents .
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
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above 18 yrs of age.
- •Single urolithiasis up to 2 cm.
- •Kidney/ureters that haven't undergone previous ESWL or stent insertion.
- •Normal renal function (creatinine below 100mmo1/1).
- •Sterile urine culture.
- •Normal CBC, blood electrolytes and coagulation studies.
- •Radioopaque stones.
排除标准
- •More than one stone per kidney unit.
- •Patients receiving steroids, NSAIDS, calcium channel blockers or alpha blockers on a regular basis.
- •Anatomical anomalies or uromechanical obstruction.
- •Single kidney.
- •Cystinuria.
- •Soldiers or pregnant women.
- •Patients under 18 year
结局指标
主要结局
stone status at 3 month .
stone free
次要结局
未报告次要终点
研究者
研究点 (1)
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