Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Departemental Vendee
• Treatments: Silodosin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.