WithdrawnNot Applicable

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

Canada0Started 2007-10

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary outcome will be Cox proportional hazards survival analysis of stone passage over time

Timeframe: 4 weeks

Trial details

NCT IDNCT00583258

SponsorUnity Health Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-09

View on ClinicalTrials.gov More Kidney Stones trials