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临床试验/NCT05570084
NCT05570084招募中3 期

Randomised Controlled Trial on Silodosin Versus Tamsulosin for Medical Expulsive Treatment of Ureteral Stones Size 5-10mm in Chinese

Princess Margaret Hospital, Hong Kong1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年5月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Stone free rate

研究概览

简要总结

The spontaneous passage rate for ureteral stone less than 1cm causing acute ureteral obstruction is about 50%. Previous Cochrane review has concluded that alpha blocker is likely to increase stone passage rate, reduce time to stone passage, analgesic use and hospitalisations. The European Association of Urology Guideline also recommends giving alpha blockers as Medical Expulsive Therapy to patients with distal ureteric stones >5mm. However there is heterogeneity in different alpha blockers.

Silodosin is a recently introduced selective alpha blocker which has a much higher selectivity for the alpha-1-A receptor (17-fold compared with tamsulosin). From previous animal studies, ureteral contraction is mainly mediated by the alpha-1-A receptor, hence silodosin maybe more effective in increasing stone passage compared with tamsulosin.

Previous studies and meta-analysis has shown superiority of silodosin over tamsulosin on earlier stone passage and less pain. However, there is no data on Chinese population.

The investigators would like to compare the efficacy and side effect profile of Silodosin versus tamsulosin on improving stone passage rate and hence reduce rate of further intervention for stone clearance.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Tamsulosin

Active Comparator

0.4mg daily for 4 weeks

干预措施: Tamsulosin (Drug)

Silodosin

Experimental

8mg daily for 4 weeks

干预措施: Silodosin (Drug)

结局指标

主要结局

Stone free rate

时间窗: FU at week 4

Wet KUB for stone passage \& RFT before FU (check 3/7 before the last FU)

次要结局

  • Pain control(FU at week 4)

研究者

发起方
Princess Margaret Hospital, Hong Kong
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ellen Yu

Research manager

Princess Margaret Hospital, Hong Kong

研究点 (1)

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