Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- time to expel kidney stone
研究概览
简要总结
In the diagnosis of renal colic gallstone , in addition to clinical and biological factors, it is a key : medical imaging. Currently , the French recommendations require at least a couple of Abdomen radiography Without Preparation lying face (ASP ) associated with abdominal ultrasound . "The abdominopelvic CT scan without injection of contrast is the examination of choice.
Current recommendations in the management of gallstone colic simply based on the joint use of analgesics , anti inflammatory drugs and control of water intake .
The mechanism of analgesic action of this treatment is a decrease in the pressure in the cavities by decrease in diuresis and inflammation treatment of ureteral permitting passage of urine . )
The expulsive medical therapy remains under evaluation. The French Association of Urology does not recommend at this time for lack of evidence deemed sufficient.
For foreign companies Urology (EAU , AUA) , the use of calcium channel blockers or alpha blockers in the treatment of symptomatic lower ureteral stones (4 to 10mm ) is recommended (grade 1A) . However, there are less formal studies of their effectiveness .
Investigators wish to demonstrate the effectiveness of alpha in medical expulsive therapy for pelvic stones 4 to 10mm .
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women on oral contraception (for women of childbearing age).
- •18 to 60 years.
- •First admission to the episode of renal colic without evidence of complication (afebrile without renal input, negative beta-hCG (women of childbearing age) without severe vomiting without uropathy malformation known underlying balance sheet. ).
- •In ability to deliver its consent.
- •patient with a single calculation pelvic ureteral 4 to 10 mm cross-sectional diameter, with or without calyx calculations (not obstructive), but other calculation ureter.
- •Unique pelvic stone :
- •Proven by imaging: helical scan without contrast injection-ASP abdominopelvic.
- •Radio-opaque to the ASP.
- •More than 3mm and <11mm (4 to 10 mm) of cross-sectional diameter.
排除标准
- •Pregnant or lactating women scalable
- •No oral contraception
- •Contraception by intrauterine device .
- •Concurrent infection ( positive urine test strip for Nitrites and / or general signs tanks (T ° C > 38 ° 5 or <36 ° 5 or chills) .
- •Renal failure ( Creatinine clearance calculated by Cockcroft and Gault <60 mL / min).
- •Single functional kidney .
- •Treatment with calcium channel blockers or alpha blockers.
- •Recent or upcoming cataract surgery .
- •Orthostatic hypotension .
- •A history of peptic ulcer disease , liver disease , allergy to paracetamol , the ketoprofen .
- •History of stroke , heart disease, diabetes.
- •History of allergy to any treatment plans.
- •Refusal to enter the protocol.
- •Already included in the protocol.
- •Medication against -indicated in combination with NSAI (vitamin K ..)
- •Hepatic Impairment
- •Participation in other biomedical research
- •Patients with a history of hypersensitivity such as bronchospasm , asthma, rhinitis , urticaria
- •Patients with asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyposis
- •History of gastrointestinal bleeding or perforation during previous treatment with NSAI or history of gastrointestinal diseases such as ulcerative colitis, Crohn's diseases, gastrointestinal bleeding , cerebrovascular bleeding or other bleeding evolving
- •Patients receiving treatment associated may increase the risk of ulceration or bleeding (glucocorticoids , selective serotonin reuptake inhibitors and antiplatelet agents such as aspirin )
- •Patients with uncontrolled hypertension, congestive heart failure , ischemic heart disease, peripheral arterial disease, and / or a history of stroke (including transient ischemic attack)
- •Patients treated with potassium-sparing drugs
- •Pelvic stone :
- •Size < 4 mm or > 10mm
- •Radiolucent
- •Not formally identified by imaging.
研究组 & 干预措施
standard treatment with Silodosin
Silodosin
干预措施: Silodosin (Drug)
结局指标
主要结局
time to expel kidney stone
时间窗: 28 days
次要结局
未报告次要终点