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

NCT02090439 | Terminated Phase 3 DMC

• 1 other identifier: CHD 062-13
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• time to expel kidney stone

  28 days

Study Arms (2)

standard treatment with Silodosin

EXPERIMENTAL

Silodosin

Drug: Silodosin

standard treatment

NO INTERVENTION

Interventions

Silodosin DRUG

standard treatment with Silodosin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men
• Women on oral contraception (for women of childbearing age).
• 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.

You may not qualify if:

• 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 ..)

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (2)

CH Loire Vendée Océan

Challans, 85302, France

Location

Centre hospitalier départemental Vendée

La Roche-sur-Yon, 85925, France

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

silodosin

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• François LUYCKX, PH

  CHD Vendée La Roche sur Yon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 18, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 11, 2016

Record last verified: 2015-11

Locations

FR (2)