L-Arginine Role for Stone Lower Ureter : A Randomized Control Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Spontaneous stone expulsion rates (SER)
研究概览
简要总结
To evaluate the effects of L-Arginine 1000mg once daily as a medical expulsive therapy (MET) for lower ureter stones.
详细描述
Urolithiasis is a common disease worldwide and its incidence is growing [1]. Urinary stones are frequently located in the ureter and most ureteral stones are reported to be located distally [2]. Stones < 3 mm in diameter have a better chance to pass spontaneously in the majority of cases, whereas stones > 6 mm in the ureter are unlikely to pass in most situations [3].
Therefore, active watchful waiting forms one of the treatment options in some clinical scenarios.
Minimal invasive treatment strategies such as extracorporeal shockwave lithotripsy and ureteroscopy are frequently applied procedures in ureteral stone disease. However, indications for watchful waiting might be extended by the addition of so-called 'expulsive medical therapy'.
Nitric Oxide (NO) L -Arginine-derived NO is the major inhibitory NANC neurotransmitter in the lower urinary tract [4]. Neuronal NO synthase (NOS)-positive neuronal axons and nerve-ending-like structures have been detected in muscular layers of the human ureter suggesting that ureteral relaxation may involve the NO pathway [5]. NOS-reactive nerves have also been demonstrated immunohistochemically in the human intravesical ureter.
A recent study suggested that the L-arginine/NO/cyclic GMP pathway may play a role in the regulation of the valve function of the ureterovesical junction [6].
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group I
about 53 patient, received NSAIDs
干预措施: NSAID (Drug)
Group II
about 53 patients received L-arginine 1000 mg once daily
干预措施: L-Arginine, 500 Mg Oral Capsule (Drug)
group III
included 51 patients who received Tamsulosin 0.4 mg once daily.
干预措施: Tamsulosin 0.4 mg QD (Drug)
结局指标
主要结局
Spontaneous stone expulsion rates (SER)
时间窗: From 1st renal colic till the time of stone pass or for four weeks
detect the rate at which stone pass from the ureter
Stone expulsion time
时间窗: From 1st renal colic till the time of stone pass or for four weeks
time at which stone pass
Number of daily colic episodes
时间窗: number of colicky attack From 1st renal colic till the time of stone pass or for four weeks
number of renal colic attack
Total required analgesic dosage
时间窗: From 1st renal colic till the time of stone pass or for four weeks
Total required analgesic dosage
次要结局
未报告次要终点
研究者
Ahmed Mahmoud Mohammed Ahmed Elsherief
lecturer of urology at faculty of medicine ,sohag university
Sohag University
