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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Embolisation with Magic Glue®
DeviceMagic 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®
DeviceEmbosphere® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Magic Glue®Experimental treatment 1 intervention
Group B: Embosphere®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of embolisation
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).
Time frame
Month 3Secondary outcomes
1
Post-Mictional Residue
Post-Mictional Residue will be assessed will be measured in ml by ultrasound
Time frame
Month 1, Month 3 and Month 122
Prostatic infarct areas
Prostatic infarct areas will be measured in mm3 on MRI
Time frame
Month 33
Sexual function
Sexual function will be assessed with IIEF5 questionnaire (International Index of Erectile Function form 5) (0 - 25 points). Score lower than 10 means severe erectile dysfunction whereas score higher than 20 means normal erectile function.
Time frame
Month 1, Month 3 and Month 124
Patient quality of life
Patient quality of life will be assessed with IPSS quality of life question (1 - 7). 1 means patient is very satisfied of his/her quality of life
Time frame
Month 1, Month 3 and Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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