Prostate Embolization for Acute Urinary Retention Study

NCT ID: NCT02689830

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-12-31

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.

Conditions

Prostatic Hypertrophy, Benign

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bead Block microspheres

Prostate embolization

Group Type: EXPERIMENTAL

Bead Block

Intervention Type: DEVICE

Prostate embolization

Interventions

Bead Block

Prostate embolization

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Biocompatibles UK Ltd

INDUSTRY

Sponsor Role: collaborator

European Georges Pompidou Hospital

OTHER

Sponsor Role: collaborator

ClinSearch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc SAPOVAL

Role: PRINCIPAL_INVESTIGATOR

HEGP, Paris

Locations

Hôpital Saint-Louis

Paris, , France

Hôpital Cochin

Paris, , France

Hôpital Européen Georges Pompidou

Paris, , France

Countries

France

Other Identifiers

SA-112043

Identifier Type: -

Identifier Source: org_study_id