Does Preoperative Tamsulosin Facilitate Semi-rigid Ureteroscopic Management of Lower Ureteric Calculi Prospective, Randomized Double Blind Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of patients need dilatation below stone
研究概览
简要总结
Ureteric calculi are one of the most common reasons for frequent Urolithiasis. The estimated prevalence is 8-13% of all calculi.
Medical expulsive therapy (MET) is recommended by the European Association of Urology (EAU) (2013) for 5-10 mm ureteric stones to facilitate stone passage. For MET, alpha blockers, mainly tamsulosin, have shown efficacy in several randomized controlled trials. The underlying pathophysiology of this therapy is supported by the presence and distribution of adrenoreceptors in the ureter. Blocking the action of alpha-1 receptors by pharmacological agents (alpha blockers), such as alfuzosin, terazosin, doxazosin, and, most typically, tamsulosin, results in the relaxation of the ureteric smooth muscle.
Ureteroscopy (URS) is the most commonly performed procedure for the treatment of ureteral calculi, with a high (>90%) stone-free rate after a single treatment. Advancing a rigid ureteroscope into a non-dilated ureter may be difficult and cause complications. Ureteric dilatation may provide access to stones, but not in all cases, and ureteral mucosal injury up to perforation might occur.
详细描述
Based on the role of alpha blockers, mainly tamsulosin, in MET of ureteric calculus, the investigator will attempt to extend the use of alpha blockers prior to URS for procedural ease. the investigator will conduct a prospective, randomized double-blind study to evaluate whether alpha blockers facilitate the negotiation of the ureteroscope if administered preoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower ureteral stone.
- •Age: 18 - 75 years.
- •normal renal function.
- •single sided ureteral stone with normal other kideny.
- •sign the informed consent.
- •Be willing/able to adhere to follow up visits.
排除标准
- •Upper and middle ureteral stones.
- •renal impairment.
- •Age < 18 years or 75 < years.
- •female who were pregnant
- •bilateral ureteric stone or solitary kidney.
- •urinary tract infection need drainage.
结局指标
主要结局
Number of patients need dilatation below stone
时间窗: intraoperative
difficult introduce the ureteroscope and reach the stone
Number of patients showing dilated ureteric orifice
时间窗: intraoperative
during ureteroscopy easy introduction in the ureter
Rate of patients develop spontaneous expulsion of stone
时间窗: up to 3 weeks pre operative
the stone spontaneously expelled without intervension
Number of patients need dormia extraction or forceps without disintegration
时间窗: intraoperative
that is due to dilated ureter so easy remove the stone
Time of operation from introduction of ureteroscope until stone extraction
时间窗: intraoperative
to know how easy introduction and expulsion of the ureteroscope
次要结局
- Rate of patients developed side effect from tamsulosin(up to 3 weeks pre operative)
- Rate of patients developed complication(intraoperative)
- Number of patients show residual stone post ureteroscopy(postoperative 4 weeks)
- Number of patients show failure of ureteroscopy(intraoperative)
研究者
Mahmoud Ahmed Gaber
Assistant Lecturer
Assiut University