Clinical trial NCT02689830: Prostate Embolization for Acute Urinary Retention Study
Official title: Prostate Embolization for Acute Urinary Retention Study (PARIS 1): An Open-label Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostatic Hypertrophy, Benign
Lead sponsor: ClinSearch
Sponsor class: OTHER
Collaborators: name: Biocompatibles UK Ltd
name: European Georges Pompidou Hospital
First posted: 2016-02-24
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedure success
timeFrame: 6 months after PAE
Secondary outcomes:
measure: Percentage of procedure related or contributed complications
timeFrame: 1 week after PAE
measure: Percentage of immediate technical success of embolization
timeFrame: 5 minutes after the beginning of the procedure
measure: Cumulative number of per-procedure angiographic and clinical complications
timeFrame: 24 hours after PAE
measure: Immediate technical success of embolization
timeFrame: 5 minutes after the beginning of the procedure
measure: Comparison of International Prostate Symptom Score
timeFrame: between pre-PAE and 3 months post-PAE
measure: Comparison of International Index of Erectile Function
timeFrame: between pre-PAE and 3 months post-PAE
measure: Comparison of Quality of Life Questionnaire
timeFrame: between pre-PAE and 3 months post-PAE
measure: Comparison of International Prostate Symptom Score
timeFrame: between pre-PAE and 6 months post-PAE
measure: Comparison of International Index of Erectile Function
timeFrame: between pre-PAE and 6 months post-PAE
measure: Comparison of Quality of Life Questionnaire
timeFrame: between pre-PAE and 6 months post-PAE
measure: Number of re-catheterization
timeFrame: 6 months after PAE
measure: Time of re-catheterization
timeFrame: 6 months after PAE
measure: Time until TransUrethral Resection of the Prostate or open surgery
timeFrame: 6 months
measure: Cumulative number of days with bladder catheter
timeFrame: between PAE and 6 months post-PAE
measure: Number of patients free of bladder catheter
timeFrame: between PAE and 6 months post-PAE
measure: Number of cumulated hospitalization days
timeFrame: between initial AUR and 6 months post-PAE
measure: Number of cumulated hospitalization days
timeFrame: between PAE and 6 months post-PAE
measure: Total number of consultations
timeFrame: between PAE and 6 months post-PAE
measure: Prostate volume
timeFrame: 6 months
measure: Comparison of the number of Benign Prostate Hypertrophy medication
timeFrame: before and 3 months after PAE
measure: Comparison of the number of Benign Prostate Hypertrophy medication
timeFrame: before and 6 months after PAE
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
affiliation: HEGP, Paris
name: Marc SAPOVAL
role: PRINCIPAL_INVESTIGATOR
References: