Skip to content

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

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02090439
Acronym
SiloMET
Enrollment
8
Registered
2014-03-18
Start date
2014-07-31
Completion date
2015-12-31
Last updated
2016-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Expulsive Medical Therapy, Kidney Stone

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 .

Interventions

DRUGSilodosin

Sponsors

Centre Hospitalier Departemental Vendee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
time to expel kidney stone28 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026