Radio-opaque beads for Prostate Artery Embolisation
Research type
Research Study
Full title
Radio-opaque bead embolic project. To determine the safety and efficacy of prostate artery embolisation (PAE) for lower urinary tract symptoms secondary to benign prostatic enlargement (LUTS BPE) with a novel radiopaque embolic agent.
IRAS ID
217945
Contact name
Timothy Bryant
Contact email
Sponsor organisation
University Hospital Southampton
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Prostate Artery Embolization (PAE) is a new Interventional Radiological technique for treating Benign Prostatic Hypertrophy (BPH). NICE has approved PAE for research purposes and a gold standard for practice has yet to be established.
The procedure is based on blocking the arteries to the prostate with microspheres injected through a catheter which is positioned in the Prostatic Artery. BTG have developed a new microsphere particle which is Radio-opaque (RO) and therefore is clearly seen during the procedure, and therefore is perhaps safer than current particles. The new RO beads are yet to be compared against currently available microspheres in terms of efficacy of treatment.This study therefore aims to evaluate the efficacy of RO beads in PAE for BPH. The study is designed as a non-inferiority trial to assess if the RO beads ellicit as effective a symptomatic outcome after 12 months as other commonly used microspheres. This will be assessed by calculating patients International Prostate Severity Score (IPSS) before the procedure and at 12 months post-procedure.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
17/WM/0193
Date of REC Opinion
29 Jun 2017
REC opinion
Further Information Favourable Opinion