NCT02689830

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

February 10, 2016

Last Update Submit

July 18, 2017

Conditions

Prostatic Hypertrophy, Benign

Outcome Measures

Primary Outcomes (1)

  • Procedure success

    percentage of patients free of Foley and/or any prostate surgery

    6 months after PAE

Secondary Outcomes (21)

  • Percentage of procedure related or contributed complications

    1 week after PAE

  • Percentage of immediate technical success of embolization

    5 minutes after the beginning of the procedure

  • Cumulative number of per-procedure angiographic and clinical complications

    24 hours after PAE

  • Immediate technical success of embolization

    5 minutes after the beginning of the procedure

  • Comparison of International Prostate Symptom Score

    between pre-PAE and 3 months post-PAE

  • +16 more secondary outcomes

Study Arms (1)

Bead Block microspheres

EXPERIMENTAL

Prostate embolization

Device: Bead Block

Interventions

Bead BlockDEVICE

Prostate embolization

Bead Block microspheres

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Saint-Louis

Paris, 75010, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Marc SAPOVAL

    HEGP, Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 24, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share

Global results will be available for patients.

Locations

FR(3)