NCT05759767进行中(未招募)不适用
The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- assess the Stone-free rate (SFR) between groups
研究概览
简要总结
The aim of this study is to evaluate the clinical efficacy and safety of MET after ESWL in pediatric urolithiasis.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radio- opaque renal stone ≤ 2 cm or ≤ 1cm lower calyceal stone
- •Normal kidney function.
排除标准
- •Bleeding diatheses
- •Uncontrolled UTIs
- •Severe skeletal malformations
研究组 & 干预措施
Tamsulosin
Active Comparator
Children in this group will receive medical expulsive therapy in the form of (tamsulosin at a dose of 0.01 mg/kg once daily for 3 weeks after ESWL session.
干预措施: Tamsulosin (Drug)
Placebo
Placebo Comparator
Children in this group will receive Placebo for 3 weeks after ESWL session.
干预措施: Placebo (Drug)
结局指标
主要结局
assess the Stone-free rate (SFR) between groups
时间窗: three months
SFR is defined as complete stone removal without visible stone fragments on radiological studies assessed by Low dose Non Contrast Computed Tomography
次要结局
未报告次要终点
研究者
研究点 (1)
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