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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB number: 2024-A01753-44 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magic Glue® | Experimental | Embolisation of the prostatic arteries will be performed with Magic Glue® combined with lipiodol |
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| Embosphere® | Active Comparator | Embolisation of prostatic arteries will be performed with 300-500 micron trisacryl particles (Embosphere®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embolisation with Magic Glue® | Device | Magic Glue® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Mictional Residue | Post-Mictional Residue will be assessed will be measured in ml by ultrasound | Month 1, Month 3 and Month 12 |
| Prostatic infarct areas | Prostatic infarct areas will be measured in mm3 on MRI |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grégory AMOUYAL, MD | Contact | + 33 6 80 70 40 40 | dr.gregory.amouyal@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Grégory AMOUYAL, MD | Clinique de l'Alma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de l'Alma | Paris | Paris | 75007 | France |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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| Embolisation with Embosphere® | Device | Embosphere® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland |
|
| Month 3 |
| 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. | Month 1, Month 3 and Month 12 |
| 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 | Month 1, Month 3 and Month 12 |
| Prostatic Serum Antigen | Prostatic Serum Antigen (PSA) will be measured from blood sample. Normal value should be lower than 4 ng/ml | Month 1, Month 3 and Month 12 |
| Urinary flow | Urinary flow will be measured in ml/s by flow measurement | Month 1, Month 3 and Month 12 |
| Prostatic volume | Prostatic volume will be in ml on MRI | Month 3 and Month 12 |
| 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). | Month 1 and Month 12 |
| Safety of embolisation | Safety of embolisation will be assessed with post-empbolisation symptoms description and other adverse events description | Day 15, Month 3 and Month 12 |
| D052801 |
| Male Urogenital Diseases |