Comparison of Glue with Microparticles in Prostatic Artery Embolization
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- NCT06678308
- Lead Sponsor
- Almaviva Sante
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 96
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Prostatic infarct areas Month 3 Prostatic infarct areas will be measured in mm3 on MRI
Post-Mictional Residue Month 1, Month 3 and Month 12 Post-Mictional Residue will be assessed will be measured in ml by ultrasound
Sexual function Month 1, Month 3 and Month 12 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.
Patient quality of life Month 1, Month 3 and Month 12 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
Prostatic Serum Antigen Month 1, Month 3 and Month 12 Prostatic Serum Antigen (PSA) will be measured from blood sample. Normal value should be lower than 4 ng/ml
Urinary flow Month 1, Month 3 and Month 12 Urinary flow will be measured in ml/s by flow measurement
Prostatic volume Month 3 and Month 12 Prostatic volume will be in ml on MRI
Efficacy of embolisation Month 1 and Month 12 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).
Safety of embolisation Day 15, Month 3 and Month 12 Safety of embolisation will be assessed with post-empbolisation symptoms description and other adverse events description
Trial Locations
- Locations (1)
Clinique de l'Alma
🇫🇷Paris, France