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

Centre Hospitalier Departemental Vendee

Status and phase

Terminated

Phase 3

Conditions

Kidney Stone

Expulsive Medical Therapy

Treatments

Drug: Silodosin

Study type

Interventional

Funder types

Other

Identifiers

NCT02090439

CHD 062-13

Details and patient eligibility

About

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 .

Enrollment

8 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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