Benign Prostatic Hyperplasia
Conditions
Keywords
PAE, embolization, non-surgical, prostate artery embolization, radio-opaque embolic
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDC Lumi Bead, BTG
Embolic agent which is radio-opaque
Sponsors
BTG International Inc.
University Hospital Southampton NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking
Intervention model description
Single group of patients undergoing prostate artery embolization with a new embolic which is radio-opaque and can give a better idea of embolization distribution (DC Lumi Beads by BTG)
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 50-80 Moderate to severe lower urinary tract symptoms secondary to benign prostatic enlargement (BPE) IPSS\>14, QOL≥4 Prostate volume ≥ 40 cc Maximum urinary flow rate \< 12ml/s Medically refractory BPE \> 6 months (or unable/ unwilling to tolerate medical treatment due to side effects)
Exclusion criteria
* Atherosclerosis of the prostatic arteries Surgical indications (Chronic retention, bladder diverticulae, urethral stenosis), detrusor instability, neurogenic bladder Malignancy (TRUS/ MRI/ Biopsy proven). PSA \> 4 or high SWOP risk need prostate biopsy Urodynamics - non-obstructed eGFR ≤ 45ml min-1m-2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | 12 months | Rate of adverse events compared with currently available other embolic agents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scale of symptomatic improvement | 12 months | 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 |
Countries
United Kingdom
Contacts
Primary ContactDrew Maclean
Outcome results
None listed