Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.
- Registration Number
- NCT02090439
- Lead Sponsor
- Centre Hospitalier Departemental Vendee
- Brief Summary
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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- Men
- 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.
- 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 :
- Multiple
- Size < 4 mm or > 10mm
- Radiolucent
- Not formally identified by imaging.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard treatment with Silodosin Silodosin Silodosin
- Primary Outcome Measures
Name Time Method time to expel kidney stone 28 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
CH Loire Vendée Océan
🇫🇷Challans, France
Centre hospitalier départemental Vendée
🇫🇷La Roche sur Yon, France