Embolisation with Magic Glue®Embolisation with Embosphere®
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
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
Study summary
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.
Eligibility
Sex
MALE
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Efficacy of embolisation — Month 3 Efficacy of embolisation will be assessed with IPSS score (International Prostate Symptoms Score). IPSS questionnaire consists of 7 questions (ranging from 0 to 5) on mictional difficulties for a maximum total of 35 points (0 means no mictional difficulty).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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