Prostate Embolization for Acute Urinary Retention Study (PARIS1)

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).

Study Overview

• Status: Unknown
• Conditions: Prostatic Hypertrophy, Benign
• Intervention / Treatment: Device: Bead Block

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hopital Europeen Georges Pompidou
  • Paris, France, 75014
    • Hopital Cochin
  • Paris, France, 75010
    • Hôpital Saint-Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bead Block microspheres; Prostate embolization	Device: Bead Block; Prostate embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure success	percentage of patients free of Foley and/or any prostate surgery	6 months after PAE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of procedure related or contributed complications		1 week after PAE
Percentage of immediate technical success of embolization	Percentage of bilateral embolization	5 minutes after the beginning of the procedure
Cumulative number of per-procedure angiographic and clinical complications	according to the Society of Interventional Radiology and Dindo classifications	24 hours after PAE
Immediate technical success of embolization	percentage of unilateral versus percentage of bilateral embolization	5 minutes after the beginning of the procedure
Comparison of International Prostate Symptom Score		between pre-PAE and 3 months post-PAE
Comparison of International Index of Erectile Function		between pre-PAE and 3 months post-PAE
Comparison of Quality of Life Questionnaire		between pre-PAE and 3 months post-PAE
Comparison of International Prostate Symptom Score		between pre-PAE and 6 months post-PAE
Comparison of International Index of Erectile Function		between pre-PAE and 6 months post-PAE
Comparison of Quality of Life Questionnaire		between pre-PAE and 6 months post-PAE
Number of re-catheterization		6 months after PAE
Time of re-catheterization		6 months after PAE
Time until TransUrethral Resection of the Prostate or open surgery		6 months
Cumulative number of days with bladder catheter		between PAE and 6 months post-PAE
Number of patients free of bladder catheter		between PAE and 6 months post-PAE
Number of cumulated hospitalization days		between initial AUR and 6 months post-PAE
Number of cumulated hospitalization days		between PAE and 6 months post-PAE
Total number of consultations	consultations with interventional radiologist and/or urologist	between PAE and 6 months post-PAE
Prostate volume	Measured with MRI or ultrasound	6 months
Comparison of the number of Benign Prostate Hypertrophy medication		before and 3 months after PAE
Comparison of the number of Benign Prostate Hypertrophy medication		before and 6 months after PAE

Collaborators and Investigators

• Sponsor: ClinSearch
• Collaborators: Biocompatibles UK Ltd; European Georges Pompidou Hospital
• Investigators: Principal Investigator: Marc SAPOVAL, HEGP, Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Prostatic Diseases; Urination Disorders; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Hypertrophy; Urinary Retention
• Other Study ID Numbers: SA-112043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Global results will be available for patients.