Overview

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Withdrawn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