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临床试验/NCT00831701
NCT00831701已完成不适用

Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-blind and Placebo-controlled Study

University of Zurich1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Number of Participants With Stone Expulsion

研究概览

简要总结

Current therapeutic options for ureteral stones include active intervention as well as conservative "watch and wait" approaches. Endoscopic treatment of ureteral stones has a high success rate and reliably results in immediate stone removal However, surgical as well as anaesthetic risks are not negligible and serious complications are possible. For many patients, a conservative treatment is an appealing option. Watchful waiting, however, not always results in stone clearance and may be associated with recurrent renal colics.

The therapeutic potential of alpha-blockers for ureteral stone disease has been investigated prompted by the detection of alpha-receptors in ureteral smooth muscle cells. Blocking of such receptors, which are predominantly located in the distal part of the ureter results in relaxation of the ureteral wall and modulation of peristaltic activity. This mechanism has been proposed to facilitate stone passage for ureteral calculi.

Numerous clinical trials have revealed a significant improvement of the stone expulsion rate using the alpha-blocker tamsulosin. Most of these studies were randomised but none were performed in a double-blind and placebo-controlled fashion. Therefore, the objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a randomised, double-blind, placebo-controlled setting.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

Tamsulosin treatment

干预措施: Tamsulosin (Drug)

Placebo

Placebo Comparator

Placebo treatment

干预措施: Placebo (Drug)

结局指标

主要结局

Number of Participants With Stone Expulsion

时间窗: 21 days

The primary end point was the number of patients per group experiencing stone expulsion until day 21, as confirmed by low-dose abdominal computed tomography (CT).

次要结局

  • Required Analgesics(Until stone expulsion or up to 21 days)
  • Maximum Daily Pain Score(Until stone expulsion or up to 21 days)
  • Time to Stone Passage(21 days)
  • Number of Participants Requiring Active Treatment(21 days)

研究者

申办方类型
Other

研究点 (1)

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