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

NCT ID: NCT02090439

Last Updated: 2016-02-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-12-31

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 .

Conditions

Kidney Stone; Expulsive Medical Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard treatment with Silodosin

Silodosin

Group Type: EXPERIMENTAL

Silodosin

Intervention Type: DRUG

standard treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Silodosin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François LUYCKX, PH

Role: PRINCIPAL_INVESTIGATOR

CHD Vendée La Roche sur Yon

Locations

CH Loire Vendée Océan

Challans, , France

Centre hospitalier départemental Vendée

La Roche-sur-Yon, , France

Countries

France

Other Identifiers

CHD 062-13

Identifier Type: -

Identifier Source: org_study_id