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

Primary Purpose

Kidney Stone, Expulsive Medical Therapy

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Silodosin
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Pelvic stone :

  • Multiple
  • Size < 4 mm or > 10mm
  • Radiolucent
  • Not formally identified by imaging.

Sites / Locations

  • CH Loire Vendée Océan
  • Centre hospitalier départemental Vendée

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

standard treatment with Silodosin

standard treatment

Arm Description

Silodosin

Outcomes

Primary Outcome Measures

time to expel kidney stone

Secondary Outcome Measures

Full Information

First Posted
March 14, 2014
Last Updated
February 10, 2016
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT02090439
Brief Title
Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.
Acronym
SiloMET
Official Title
Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Following difficulties in patient recruitment, we were forced to stop the study prematurely.
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Expulsive Medical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard treatment with Silodosin
Arm Type
Experimental
Arm Description
Silodosin
Arm Title
standard treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Silodosin
Primary Outcome Measure Information:
Title
time to expel kidney stone
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François LUYCKX, PH
Organizational Affiliation
CHD Vendée La Roche sur Yon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Loire Vendée Océan
City
Challans
ZIP/Postal Code
85302
Country
France
Facility Name
Centre hospitalier départemental Vendée
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France

12. IPD Sharing Statement

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

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