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

Kidney Stone Clinical Trial

— SiloMET  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02090439
• Other study ID #: CHD 062-13
• Status: Terminated
• Phase: Phase 3
• First received: March 14, 2014
• Last updated: February 10, 2016
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Expulsive Medical Therapy
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

Drug:
• Silodosin

Locations

Country	Name	City	State
France	CH Loire Vendée Océan	Challans
France	Centre hospitalier départemental Vendée	La Roche sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to expel kidney stone		28 days	No