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

Not Applicable

Withdrawn

• Conditions: Kidney Stones
• Interventions: Drug: Alfuzosin (Xatral); Drug: Placebo Alfuzosin

• Registration Number: NCT00583258
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-31
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Alfuzosin (Xatral)	-
B	Placebo Alfuzosin	-

Primary Outcome Measures

Name	Time	Method
The primary outcome will be Cox proportional hazards survival analysis of stone passage over time	4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates	4 weeks

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada