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临床试验/NCT03274700
NCT03274700Unknown早期 1 期

The Use of Tamsulosin in Treatment of (10-15 mm) Lower Ureteric Stones in Adults With Non-emergent Symptoms: A Prospective Randomized Study

Assiut University0 个研究点目标入组 80 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
80
主要终点
Theraputic effect of tamsulosin as assessed by number of cases of expulsed ureteric stones.

研究概览

简要总结

To estimate the efficacy of tamsulosin in:

A - Expulsion of lower ureteric stones from10-15 mm diameters (primary goal).

B - Pain relief and hyronephrosis improvement (secondary goal).

详细描述

Urolithiasis affects 4-15% of world population and the incidence of this disease is increasing day by day . Of all the urinary tract stones, 20% are ureteral stones, and 70% of these ureteral stones are found in the distal part of the ureters . The goal of treatment of patients suffering from ureteral calculi is to achieve complete stone clearance with minimal morbidity .

Ureteral calculi of any size may be associated with renal obstruction and care must be taken to prevent irreversible damage to kidney, whether patient selects expectant or active treatment . An expectant treatment or watchful waiting approach may be expected to produce spontaneous stone expulsion up to 50% of cases but some complications such as urinary infection, hydronephrosis, and repetitive colicky pain may occur . Once a conservative approach proves to be unsuccessful, interventional treatment becomes necessary. After a period of conservative treatment, however, intervention is often inefficient or has a higher risk for complications due to stone impaction and the associated inflammatory reaction of the ureter . Non-invasive treatment with extracorporeal shockwave lithotripsy and minimal invasive approach with ureteroscopy allow ureterolithiasis to resolve in almost all cases but these procedures are not risk free and they require some experience and not cost effective .

The therapeutic potential of α-blockers for ureteral stone disease has been investigated, prompted by the detection of α-receptors in ureteral smooth muscle cells . We choose to focus on tamsulosin because it is the most frequently studied α-blocker, recommended in urology treatment guidelines, and, in our experience, the most common medical expulsive therapy used by emergency physicians .

The objective of this trial was to evaluate the efficacy of MET with tamsulosin for ureteral stones from 10-15 mm diameter in a randomised, placebo-controlled setting.

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 (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lower ureteric stones from(10-15) mm diameters.
  • Age group equal or more than 18 years.
  • Normal renal function.

排除标准

  • Lower ureteric stones less than 10mm and more than 15 mm diameters.
  • Age group less than 18 years.
  • Associated ureteric strictures.
  • Febrile urinary tract infections.
  • Severe hydronephrosis.

研究组 & 干预措施

Group 1: Patients receive tamsulosin

Active Comparator

Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing:

In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones.

At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones.

At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.

干预措施: Tamsulosin. (Drug)

Patients receive placebo.

Placebo Comparator

Patients who will receive placebo up to 8 weeks duration.The cases will be followed up as following:

In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones.

At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones.

At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.

干预措施: Placebo. (Drug)

结局指标

主要结局

Theraputic effect of tamsulosin as assessed by number of cases of expulsed ureteric stones.

时间窗: 1year

Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing: In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones. At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones. At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mahmoud eldardery

resident

Assiut University

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