Comparison of Glue with Microparticles in Prostatic Artery Embolization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Embolisation with Magic Glue®, Embolisation with Embosphere®.
- Who it may be relevant to
- Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: 50 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Efficacy and Safety of Glue with Calibrated Microparticles in Prostatic Artery Embolisation As a Treatment for Symptomatic Benign Prostatic Hyperplasia.
Overview
Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH). It has been practised since 2012 and numerous publications have proved not only its safety but also its efficacy. The principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate. The reference embolisation agent is a suspension of calibrated trisacryl microparticles 300-500 microns in size. Recently, the use of glue has been retrospectively studied with acceptable efficacy and safety. In this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.
Detailed description
Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH), and its place is recognised in the recommendations of the Male Voiding Disorders Committee (French Urological Association). It has been practised since 2012 (Carnevale et al, 2020), and numerous publications have proved not only its safety but also its efficacy (Malling et al, 2019).
The principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate.
The reference embolisation agent, used by the majority of expert prostate embolisation teams, is a suspension of calibrated trisacryl microparticles 300-500 microns in size.
Recently, the use of glue has been retrospectively studied with acceptable efficacy and safety (Loffroy et al, 2021). Another retrospective comparative study (Salet et al, 2022) reported no significant difference in clinical efficacy between the use of glue and 300-500 micron trisacryl particles.
In this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.
Interventions
- Device Embolisation with Magic Glue®
Magic Glue® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland - Device Embolisation with Embosphere®
Embosphere® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland
Primary outcome measures
- Efficacy of embolisation [Time frame: Month 3]
Secondary outcome measures (9)
- Post-Mictional Residue [Time frame: Month 1, Month 3 and Month 12]
- Prostatic infarct areas [Time frame: Month 3]
- Sexual function [Time frame: Month 1, Month 3 and Month 12]
- Patient quality of life [Time frame: Month 1, Month 3 and Month 12]
- Prostatic Serum Antigen [Time frame: Month 1, Month 3 and Month 12]
- Urinary flow [Time frame: Month 1, Month 3 and Month 12]
- Prostatic volume [Time frame: Month 3 and Month 12]
- Efficacy of embolisation [Time frame: Month 1 and Month 12]
- Safety of embolisation [Time frame: Day 15, Month 3 and Month 12]
Eligibility criteria
Inclusion criteria
- Male patient aged ≥ 50 years and ≤ 80 years
- Patient with symptomatic BPH (prostatic volume ≥ 40 ml measured on prostatic MRI, IPSS ≥ 8, uroflowmetry < 15 ml/s).
- Patient failing or intolerant to drug treatment (tadalafil and/or one of the alpha-blockers, alfuzosin, tamsulosin, silodosin or doxazosin).
Exclusion criteria
- Patient with advanced and complicated BPH on renal and bladder ultrasound:
Severe obstruction related bladder wall lesions : >3 micro-diverticula or single or multiple diverticula with a sac diameter > 10 mm.
Chronic dilatation of the excretory cavities : diameter of one or both pyelons >15 mm.
- Patient with suspected prostate or bladder cancer on MRI
- Patients with moderate or severe chronic renal failure, with creatinine clearance < 40 ml/min.
- Patient with prostate or bladder cancer diagnosed by biopsy in the 6 months preceding the inclusion visit.
- Patient with an active urinary tract infection
- Patient already included and participating in another clinical study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Clinique de l'Alma — Paris
Identifiers
NCT: NCT06678308 · 2023-08 · ID-RCB number: 2024-A01753-44