This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution.
This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution. It would also give us answers to: * How does embolic efficacy compare to current available embolic agents? * Does enhancement on rotational CT correlate with embolic distribution? * How does embolic distribution compare with tissue infarction? * Does the density of embolic packing correlate with degree of infarction and volume loss? * How predictable is superselective target embolisation? * Does embolic distribution vary with anatomy and gland size? * Does embolic distribution tally with glandular enhancement/ transitional zone vascularity? * If visible, what is the effect and significance of non target embolisation? This is a cohort study aiming to recruit 22 patients to power a non-inferiority assessment comparing the novel embolic agent against current available embolics. Data will be added to our on going local registry of patients who have undergone this procedure . This will provide information about how safe and effective it is for patients and how it compares to the other established embolic agents such as polyvinyl alcohol (PVA) and other spherical agents such as Embospheres and Embozenes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Embolic agent which is radio-opaque
Southampton General Hospital, University Hospital Southampton
Southampton, United Kingdom
RECRUITINGAdverse event rate
Rate of adverse events compared with currently available other embolic agents
Time frame: 12 months
Scale of symptomatic improvement
symptomatic improvement will be gauged used the internationally recognised IPSS questionnaire. Decrease in IPSS score in study participants will be compared against other embolic agents in the literature
Time frame: 12 months
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