A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones

Unity Health Toronto

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Kidney Stones

Interventions

Alfuzosin (Xatral)DRUG

10 mg PO once a day

Placebo AlfuzosinDRUG

10 mg PO once a day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Michael's Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

The primary outcome will be Cox proportional hazards survival analysis of stone passage over time

Time frame: 4 weeks

Secondary Outcomes

Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates

Time frame: 4 weeks

Data from ClinicalTrials.gov

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