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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Kidney Stones
• Intervention / Treatment: Drug: Alfuzosin (Xatral); Drug: Placebo Alfuzosin

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: Alfuzosin (Xatral); 10 mg PO once a day
Placebo Comparator: B	Drug: Placebo Alfuzosin; 10 mg PO once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome will be Cox proportional hazards survival analysis of stone passage over time	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates	4 weeks

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Sanofi
• Investigators: Principal Investigator: Kenneth A Pace, MD, FRCSC, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 20, 2007
• First Posted (Estimate): December 31, 2007

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Alfuzosin
• Other Study ID Numbers: SMHXATRAL2007; ALFUS-L-00811