Prostatic Hypertrophy, Benign Clinical Trial
Official title:
Prostate Embolization for Acute Urinary Retention Study (PARIS 1): An Open-label Prospective 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.
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