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

NCT00583258 — Not applicable, Withdrawn, Unity Health Toronto

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A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi

Registry	NCT00583258
Status	Withdrawn
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Sponsor	Unity Health Toronto (Other); collaborators: Sanofi
Conditions	Kidney Stones
Interventions	Alfuzosin (Xatral), Placebo Alfuzosin (Drug)
Dates	start 2007-10-01, primary completion 2009-09-01, completion 2009-10-01, first posted 2007-12-31, last updated 2015-07-31
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
A	Experimental	Drug: Alfuzosin (Xatral)
B	Placebo comparator	Drug: Placebo Alfuzosin

Alfuzosin (Xatral) (Drug): 10 mg PO once a day
Placebo Alfuzosin (Drug): 10 mg PO once a day

+Outcome measures

Primary outcomes

The primary outcome will be Cox proportional hazards survival analysis of stone passage over time [4 weeks]

Secondary outcomes

Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates [4 weeks]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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)

Facility	City	Country	Status
St. Michael's Hospital	Toronto, Ontario	Canada

+Investigators

Kenneth A Pace, MD, FRCSC, Principal investigator, Unity Health Toronto

My Notes

Public

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