Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-02

Study Completion Date

2021-06-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking

Study Groups

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Radio-opaque embolic arm

Patients will undergo intervention in the form of prostate artery embolization with the new radio-opaque embolic "Lumi-Bead" developed by BTG plc.

Group Type EXPERIMENTAL

DC Lumi Bead, BTG

Intervention Type DEVICE

Embolic agent which is radio-opaque

Interventions

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DC Lumi Bead, BTG

Embolic agent which is radio-opaque

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No