Kidney Stones
Conditions
Brief summary
Patients who present for the first time to Emergency Room with renal colic due to a distal ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive Xatral 10mg po once a day or placebo once discharged from the ER. The purpose of this study is to assess if patients treated with Xatral will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.
Interventions
10 mg PO once a day
DRUGPlacebo Alfuzosin
10 mg PO once a day
Sponsors
Sanofi
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* first presentation to ER with renal colic secondary to a distal ureteral stone diagnosed on spiral CT scan * stone radiopaque on KUB, distal to the sacro-iliac joint * patient suitable for discharge from ER * patient willing to return for follow-up on a weekly basis for maximum 4 visits
Exclusion criteria
* more than one ureteral calculi * radiolucent stones or cystine stones * prior ipsilateral calculus or ureteral surgery * congenital anomalies of the ureter * patients presents with an absolute indication for intervention * allergy or contraindication to NSAIDs (history of orthostatic hypotension, current systolic BP \<90 mmHg) * patient currently taking an alpha-blocker * hepatic insufficiency * pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be Cox proportional hazards survival analysis of stone passage over time | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates | 4 weeks |
Countries
Canada
Outcome results
None listed