Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 6
- 主要终点
- Time to stone elimination in days (censored criterion)
研究概览
简要总结
Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.
详细描述
Ureteral colic, mainly due to ureterolithiasis, represents 1 to 2% of hospital emergency admissions. When a surgical intervention is not required, usual treatment combines hydration and anti-inflammatory drugs.
Alpha1-blockers, firstly developed as anti-hypertensive drugs, are now also used in the management of benign prostatic hyperplasia, due to their relaxing properties on the urinary tract. The aim of the study is to investigate whether tamsulosin could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis. Patients are randomized to receive either tamsulosin or a placebo in addition to usual treatment until stone elimination. Efficacy is assessed by evaluating the time to spontaneous passage of the stone between day 1 and day 42, the need for surgery and pain recurrences.
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
- •Adult over 18 years
- •Emergency admission for a ureteral colic
- •Radio-opaque ureterolithiasis
- •Stone of 2 to 7 mm diameter
- •Informed written consent
排除标准
- •Pregnancy or breast-feeding
- •Treatment with alpha or beta-blocker
- •Contraindication to tamsulosin (orthostatic hypertension, hepatic failure)
- •Complication needing surgery
- •Calculi spontaneous passage before randomization
- •Patient not available for a 6 week follow-up
研究组 & 干预措施
1
Tamsulosin
干预措施: Tamsulosin (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to stone elimination in days (censored criterion)
时间窗: between day 1 and 42
次要结局
- Pain using Visual Analogue Scale(days 1, 2, 3)
- Time to surgery in days in patients with surgical elimination(between day 1 and day 42)
- Rate of pain recurrences(within 42 days)
- Time to the first recurrence in days(between day 1 and day 42)
- Rate of need for corticoids or morphine(Within 42 days)
- Time to the first administration of corticoids or morphine in days(between day 1 and day 42)
- Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion)(between day 1 and 42)
- Spontaneous stone elimination rate(days 1, 7, 14, 21, 28, 35, and 42)
- Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm)(days 1, 7, 14, 21, 28, 35, and 42)
- Rate of need for surgery(Within 42 days)
- Rate of adverse events(Within 42 days)