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

Unity Health Toronto

Status: Withdrawn

Conditions: Kidney Stones

Treatments: Drug: Alfuzosin (Xatral); Drug: Placebo Alfuzosin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00583258

SMHXATRAL2007

ALFUS-L-00811

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Alfuzosin (Xatral)

B

Placebo Comparator group

Treatment:

Drug: Placebo Alfuzosin