Comparison of Glue with Microparticles in Prostatic Artery Embolization
ConditionBenign Prostatic Hyperplasia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-80
SponsorAlmaviva Sante
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Embolisation with Magic Glue®
- Embolisation with Embosphere®
Treatment groups
96 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov