Comparative Study Between Tadalafil Versus Tamsulosin as a Medical Expulsive Therapy for Lower Ureteric Stones
试验速览
- 阶段
- 4 期
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Lower ureteric stone expulsion
研究概览
简要总结
The aim of the work is to compare the efficacy of tadalafil and tamsulosin as a medical expulsive therapy for lower ureteric stones
详细描述
Gradually increasing incidence rate of kidney stone is a significant concern of medical world. Genetics and/or life style accelerate the kidney stone formation (Urolithiasis). Sometimes, it is stuck up in ureter especially distal ureter; hence called as lower ureteral stone (LUS) and causes intense flank pain beside urinary obstruction.
The ureter contains α adrenergic receptors along its entire length with the highest concentration in the distal ureter.
There has been a steep rise in minimally invasive procedures but medical expulsive therapy (MET) is still regarded as an established treatment option for the management of distal ureteric stones.
Stone location, size, number, ureteric spasm, mucosal oedema or inflammation, and ureteric anatomy are the factors affecting passage of ureteric stones.
Drugs that expel stones might act by relaxing ureteral smooth muscle through inhibition of calcium channel pumps or α-1 receptor blockade. Tamsulosin is one of the most commonly used α-blockers.
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
- Single (Participant)
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
- •Patients aged ≥18 years
- •Patient have a distal ureteric stone of 5-9 mm in greatest dimension
- •Patient diagnosed by ultrasonography of the kidney, ureter, and bladder , X-ray KUB and noncontrast computed tomography scan.
排除标准
- •Pregnant or lactating mothers.
- •Patients have UTI.
- •Patients have severe hydroureteronephrosis.
- •Patients have multiple ureteric stones.
- •Patients have solitary kidney.
- •Patients have acute or chronic renal failure.
- •Patients have previous therapies for the stone.
- •Patients with history of open surgery/endoscopic interventions.
- •Patients have ureteric strictures.
- •Patients take concomitant treatment with calcium antagonists, β-blockers, corticosteroids or nitrates.
研究组 & 干预措施
Tamsulosin treated group
83 patient with lower ureteric stone will take tamsulosin 0.4 mg once daily .Therapy will be given for a maximum of 4 weeks.
干预措施: Tadalafil versus tamsulosin as MET (Drug)
Tadalafil treated group
83 patients with lower ureteric stone will take tadalafil 10 mg once daily. Therapy will be given for a maximum of 4 weeks.
干预措施: Tadalafil versus tamsulosin as MET (Drug)
结局指标
主要结局
Lower ureteric stone expulsion
时间窗: 4 weeks
Measuring lower ureteric stone expulsion rate with tadalafil versus tamsulosin
次要结局
未报告次要终点
研究者
Ahmed Saleh Mostafa
Urology specialist
Beni-Suef University