UnknownNot Applicable

Prostate Embolization for Acute Urinary Retention Study

France20 participantsStarted 2016-03

Plain-language summary

The purpose of this study is to assess the feasibility and safety of Prostate Artery Embolization (PAE) in patients suffering of Acute Urinary Retention (AUR) in the context Benign Prostatic Hypertrophy (BPH).

Who can participate

Age range

18 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: * AUR Patients presenting with a first episode of AUR related to BPH (no matter if previously known or not) AND * Failure of at least one TWOC AND * Prostate size \> or = 50 ml (ultrasound measurement) Exclusion Criteria: * Known hypocontractile bladder * AUR related to other causes (Acute prostatitis or documented Prostate cancer) * Severe iodine allergy * Known prostate cancer * Known ongoing acute or chronic prostatitis * On-going acute pyelonephritis or septicemia from urinary origin * Patient refusing PAE * Severe renal failure (creatinine Clearance \< 20 ml/min (MDRD) * Contra-indication to AR blockers (postural hypotension micturition syncope) * Contra-indication to anticoagulants * Patient catheterized with a suspubian catheter * Patient \<18 * Patients who are prisoners * Patients who are mentally incapacitated * Patients participating in an investigational study involving the peripheral vasculature * Patients unable or unwilling to provide written informed consent * Patients ineligible for pelvic angiography and embolization including severe atheromatous condition or any anatomical condition

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

Procedure success

Timeframe: 6 months after PAE

Trial details

NCT IDNCT02689830

SponsorClinSearch

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07

View on ClinicalTrials.gov More Prostatic Hypertrophy, Benign trials