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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 February 2016
• Main ID: NCT02090439
• Date of registration: 14/03/2014
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Departemental Vendee
• Public title: Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm. SiloMET
• Scientific title: Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.
• Date of first enrolment: July 2014
• Target sample size: 8
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02090439
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: François LUYCKX, PH
• Affiliation: CHD Vendée La Roche sur Yon

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Expulsive Medical Therapy

Kidney Stone

Intervention(s)

Drug: Silodosin

Primary Outcome(s)

time to expel kidney stone [Time Frame: 28 days]

Secondary ID(s)

CHD 062-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors