Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- stone free rate
研究概览
简要总结
This a study aiming to compare treatment with tamsulosin versus placebo in patients undergoing endoscopic treatment for urolithiasis. The main outcome is the rate of stone free patients.
详细描述
Endoscopic treatment of urolithiasis has increased during the last several years. Adrenergic receptors have been described mainly in the distal ureter. Blockage of adrenergic receptors has been associated to a decrease in ureteral resistance. In this study the investigators hypothesized that alpha blockers are associated to a decrease in ureteral resistance with an increase in successful endoscopic management of urolithiasis.
Only patients with urolithiasis undergoing to endoscopic treatment are offered to participate. Patients are randomized between placebo arm or tamsulosin 0.4 mg/day. Demographic characteristics, stones characteristics and information related to surgery are recorded. Main study outcome is stone free rate and successful insertion of semirigid ureteroscope 8,0 - 9,8 Fr. All patients are follow-up for 30 days after surgery.
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
- Triple (Participant, Care Provider, 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
- •Patients with urolithiasis undergoing to endoscopic ureterolithotomy
排除标准
- •Patients with previous ureteral catheter
- •Patients with allergy to tamsulosin
- •Patients currently in treatment with tamsulosin for other disease different than ureterolithiasis
- •Multiple ureterolithiasis
- •Patients with impairment of their mental status
- •Patients with open surgeries in the affected ureter or urinary diversion
- •Pregnancy
研究组 & 干预措施
tamsulosin hydrochloride
Tamsulosin hydrochloride 0,4 mg tablets by mouth per day for 5 days before ureteroscopy
干预措施: Tamsulosin Hydrochloride 0.4 milligrams (Drug)
Placebo oral tablet
Placebo oral tablets by mouth per day for 5 days before ureteroscopy
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
stone free rate
时间窗: 30 days
stone free rate after ureteroscopic management of urolithiasis
次要结局
- failed ureteroscopy rate(05 days)