NCT00583258
Withdrawn
Not Applicable
A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi
ConditionsKidney Stones
Overview
- Phase
- Not Applicable
- Intervention
- Alfuzosin (Xatral)
- Conditions
- Kidney Stones
- Sponsor
- Unity Health Toronto
- Locations
- 1
- Primary Endpoint
- The primary outcome will be Cox proportional hazards survival analysis of stone passage over time
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
A
Intervention: Alfuzosin (Xatral)
B
Intervention: Placebo Alfuzosin
Outcomes
Primary Outcomes
The primary outcome will be Cox proportional hazards survival analysis of stone passage over time
Time Frame: 4 weeks
Secondary Outcomes
- Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates(4 weeks)
Study Sites (1)
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