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

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 .

Study Overview

• Status: Terminated
• Conditions: Kidney Stone; Expulsive Medical Therapy
• Intervention / Treatment: Drug: Silodosin

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Challans, France, 85302
    • CH Loire Vendée Océan
  • La Roche sur Yon, France, 85925
    • Centre Hospitalier Départemental Vendée

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard treatment with Silodosin; Silodosin	Drug: Silodosin
No Intervention: standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time to expel kidney stone	28 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: François LUYCKX, PH, CHD Vendée La Roche sur Yon

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 14, 2014
• First Submitted That Met QC Criteria: March 14, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Estimate): February 11, 2016
• Last Update Submitted That Met QC Criteria: February 10, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Nephrolithiasis; Kidney Calculi; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Silodosin
• Other Study ID Numbers: CHD 062-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No