Prostate Embolization for Acute Urinary Retention Study
Prostate Embolization for Acute Urinary Retention Study
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).
This is an open-label prospective, multicenter (centralized procedure), single arm,
 sequentially enrolling study. Twenty subjects will be enrolled in the study.

 Patient will be referred by the attending urologists after failure of the currently
 recommended approach of Trial WithOut Catheter (TWOC) and alpha-adrenergic receptor (AR)
 blockers.

 It is expected that all AUR cases referred to the local urological clinic will be considered
 for inclusion in the trial. A trial log book will be completed by the referring local
 urologist in order to obtain preliminary data on the applicability of the trial to all AUR
 comers in the institution. This log book will be limited to a very simple questionnaire to
 ensure high rate of completion by the attending resident/fellow (Patients age, size of
 prostate, previous Benign Prostate Hypertrophy symptoms, renal function). It will be used in
 order to assess the external validity of this first phase trial and will be a help to design
 the potential next step trial.

 When a patient will present with AUR in the corresponding urological clinic, the PI and
 Clinical research coordinator will be informed by a short text message, fax or e-mail in
 order to prepare the following process.

 Patient will be informed by the urologist of the ongoing research project. In summary, this
 will consist in informing the patient that the first step is TWOC and in case of failure of
 TWOC several options are offered including PAE in the trial setting. Inclusion of the patient
 will considered only in case of failure of TWOC.

 If the patient is willing to participate, patient will be seen in clinic by the Principal
 Investigator or co-investigator in order to inform him of the protocol and obtain signed
 informed consent.

 PAE will be scheduled upon the first contact to make sure that PAE is performed in a short
 delay following failure of TWOC. The goal is to perform PAE in the week following
 recatheterization. For practical reasons this delay might be extended and will be recorded in
 the Case Report Form.
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