Prostate Embolization in Chronically Surveyed Patients: E... | NCT04006431

Studies
Prostate Embolization in Chronically Surveyed Patients: Effectiveness of Unilateral vs. Bilateral Embolization

NCT04006431

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Dec 1, 2025Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Unilateral vs Bilateral Embolization of the Prostate Arteries

Interventions

embolization

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 4, 2019Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jul 1, 2019

First Submission Date that Met QC Criteria

Jul 1, 2019

First Posted Date

Jul 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Dec 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prostate embolization is an alternative treatment to trans urethral prostate resection in the context of benign prostatic hypertrophy. This embolization treatment is also of interest in patients with chronic anuria surveyed in relation to their prostatic hypertrophy for disundation. This survey causes discomfort and urinary tract infection. It is a population with tortuous arteries, a severe atherosclerotic overload making embolizations complex and long. Often, only unilateral embolization is possible. The purpose of this study is to compare the effectiveness in terms of disundation of unilateral vs. bilateral embolization of the prostatic arteries

Detailed Description

Method of observation or investigation chosen:

Retrospective, observational collection with division of patients into two groups according to unilateral or bilateral embolization of the porstatic arteries.

Origin and nature of the data Patient's medical record: imaging stored in the PACS to confirm unilateral or bilateral embolization, perform measurements of prostate volume, urological medical record to see the effectiveness of embolization in terms of disundation, comfort of life, tolerance of embolization, effectiveness in terms of urination (IPSS score)

Data flow mode:

Data stored in redcap.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
embolization	Other	Retrospective, observational collection with division of patients into two groups according to unilateral or bilateral embolization of the porstatic arteries.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the effectiveness of embolization	International prostate score symptomsScore	at one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elderly patients (>70 years old)
with contraindications to surgery,
with a chronic urinary catheterization

Exclusion Criteria:

<70 years old
without contraindications to surgery
without chronic urinary catheterization

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Elderly patients (>70 years of age) with contraindications to surgery, chronically probed

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nîmes		Nîmes		30029	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35963778	Result	Frandon J, Belaouni A, Pellerin O, Thiounn N, Serrand C, Droupy S, Petitpierre F, Vernhet-Kovacsik H, Murez T, Vidal V, Ghelfi J, Pagnoux G, Codas R, de Forges H, Beregi JP, Sapoval M. Efficacy and safety of prostate artery embolization for patients with lower urinary tract symptoms and indwelling urinary catheter: A retrospective multicenter study. Diagn Interv Imaging. 2022 Dec;103(12):601-606. doi: 10.1016/j.diii.2022.07.002. Epub 2022 Aug 10.

ID	Term
D006489	Hemostatic Techniques
D013812	Therapeutics
D060205	Therapeutic Occlusion