Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-blind and Placebo-controlled Study
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tamsulosin
Tamsulosin treatment
干预措施: Tamsulosin (Drug)
Placebo
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)
