TerminatedPhase 3

Alfuzosin Versus Placebo in Acute Urinary Retention

Stopped: The study was early terminated due to slow and difficult recruitment

Denmark160 participantsStarted 2004-05

Plain-language summary

The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin compared to placebo, will increase the number of patients with satisfying spontaneous voiding after acute urinary retention treated with Clean Self-Catheterization. Furthermore is investigated the safety of the medical treatment and self-catheterization.

Who can participate

Age range

50 Years

Sex

MALE

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: * Men with acute urinary retention and catheterized * Benign hypertrophia of prostate * Patient is diagnosed in Emergency room or at a acute hospitalization Exclusion Criteria: * Known prostate cancer * Prior urinary retention within 30 days * Urinary retention occurring in relation to surgery * Blood in urine * Difficult or impossible catheterization * Fever \> 38 degree Celsius * Decreased kidney function * Permanent catheter \> 14 days * Treatment with alfa 1 blocker within 30 days * Meeting contraindications to treatment with Alfuzosin * Treatment with other drugs for urinary problems The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial.

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

Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.

Trial details

NCT IDNCT00453908

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Urinary Retention trials