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

• Status: Withdrawn
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Michael's Hospital, Toronto; Unity Health Toronto
• Collaborator: Sanofi
• Treatments: Alfuzosin

Criteria

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