The Efficacy of Alpha-blockers for Expulsion of Distal Ureteral Stones
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- analgesics consumption
研究概览
简要总结
Most of the patients suffering from renal colic have a distal ureterolithiasis. It had been demonstrated that α adrenoreceptors antagonists, given to patients suffering from renal colic, due to distal ureterolithiasis, had increased the frequency of stone expulsion rate , reduced the time to expulsion and reduced analgesics consumption.Most of the studies evaluated the efficacy of Tamsulosin, which is a selective α 1A and α 1D adrenoreceptors antagonist.(The lower intramural portion of the ureter, where it passes through the detrusor muscle contains mostly α 1D and α 1A adrenergic receptors)
Only one study these days describes the use of Alfuzosin, which is an α adrenergic receptor blocker and not selective for any α 1 adrenergic receptor, for expulsion of distal ureteric stones.Alfuzosin is a drug with a proven efficacy and considered uroselective with high specificity and sensitivity, for the treatment of BPH. There was no significant difference in efficacy between the two α blockers (Alfuzosin vs. Tamsulosin) concerning symptoms relief or flow improvement.
The objective of this study is to compare patient who would receive the standard treatment for distal ureterolithiasis (analgesics, Rowatinex) to patients who would receive also a non selective α blocker (Alfuzosin) or a selective α blocker (Tamsulosin). This in order to evaluate the efficacy of treatment with α blockers for expulsion of distal ureterolithiasis.
详细描述
The efficacy of alpha-blockers for expulsion of distal ureteral stones
Urolithiasis is estimated among 8%-15% of the population in Europe and North America.1-5 Patient who suffer from renal colic represent a very common reason for visiting the emergency room or for hospitalization. The stones are usually located in the ureter, mostly in its lower third.
Some of the distal ureteral stone would pass spontaneously, depending on a few factors such as the stone's size, location, shape, smooth muscle spasm, submucosal edema and anatomy.
Since renal colic is one of the most painful conditions, the time until expulsion of the stone should be reduced as much as possible. In case the stone obstructs and does'nt pass, damage to the kidney might occur, and surgical intervention should be considered. However, surgery and anesthesia are not risk free.
The local reaction to obstructing ureterolithiasis manifests in ureteric smooth muscle contraction, edema, inflammation and pain. The ureter contains α -adrenergic receptors in the smooth muscle layer, along it's entire length. Since these receptors play an important role in ureteric contraction during renal colic, several studies were performed in order to evaluate the effect of α receptors blockade. These studies had demonstrated that different α blockers had increased the frequency of stone expulsion rate among patients with renal colic, reduced the time to expulsion and reduced analgesics consumption.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •renal colic due to radiologically proven distal ureteral stones
排除标准
- •stone larger than 10 mm
- •urinary tract infection
- •additional stones, that might be the reason for the renal colic
- •severe hydronephrosis
- •known sensitivity to α blockers
- •concomitant treatment with α blockers, β blockers, calcium antagonists, and nitrates
- •pregnancy
- •inability to provide informed consent
- •a history of surgery or endoscopic procedures in the urinary tract
- •history of spontaneous stone expulsion
- •known ureteral stricture
- •blood pressure values lower than 100/70 mm hg
结局指标
主要结局
analgesics consumption
frequency of stone expulsion
time to stone expulsion
次要结局
未报告次要终点