Embolisation of the prostatic artery in patients with symptomatic benign prostate hyperplasia:
A prospective single arm cohort-study.

Benign prostate hyperplasia (BPH) is one of the most common pathologic entities
in men, affecting over 50% of men older than 60 years of age, and over 90% of
men older than 80 years (1-4) . Although this condition is benign, BPH may
cause low urinary tract symptoms (LUTS). To objectively quantify LUTS in
patients the International Prostate Symptom Score (IPSS) is used. BPH with LUTS
is generally treated conservatively with medical therapy. Although many
patients will demonstrate improvement, a substantial proportion will not
benefit from conservative therapy. Patients with symptoms refractory to medical
therapy are potential candidates for minimally invasive or surgical procedures.
The golden standard therapy is trans-urethral resection of the prostate (TURP),
with high success- and low morbidity-rates. However, in high volume BPH cases
the TURP success-rate drops, re-interventions are more often needed and a
higher (post-)procedural morbidity-rate is reported.(5). Therefore
open-prostatectomy, a more invasive treatment, in large volume BPH is needed.
Although open-prostatectomy demonstrates good clinical results it can be
related to serious major complications which can be a threat for the elderly
patient.
Prostate artery embolization (PAE) is a minimal therapy for patients with BPH
and LUTS with promising results. (6,7) As opposed to the former, the
efficacy-rates for PAE in high volume BPH are promising with only few reported
adverse events; side-effects and complications. (8,9) PAE is a valuable
treatment alternative to transurethral surgery in patients with symptomatic
BPH.


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The assess the safety and efficacy of prostate artery embolization (PAE) with
polyethylene glycol microspheres (PEGM) in patients with low urinary tract
symptoms (LUTS) due to benign prostate hyperplasia (BPH).

Prospective single-arm cohort study.

After out-patient urology consultation and informed consent, patients undergo
in-patient PAE. Before PAE all patients have blood examination (GFR, CBC,
creat, PSA, coagulation status) and corrected accordingly. Bilateral puncture
of the common femoral artery is performed, placing a 4F catheter in the
contralateral internal iliac artery for diagnostic imaging (DSA) in
cranio-/oblique (10°/40°) projection (± 3D angiography and/or coned beam CT)
in order to identify the main branches and the origin of the prostatic artery
on each side. A micro catheter is selectively placed distally in the
prostatic artery. In case of collateral pathways to non-targeted areas, a
proximal coiling of these branches will be performed. Embolization using
polyethylene glycol microspheres (PEGM), sized 400µm and/or 600 µm
(HydroPearl®). The embolization end point is until stasis of the contrast is
achieved.

vascular complication, e.g. inguinal hematoma (1.9%),
non-targeted embolization, e.g. bladder necrosis, <0.1%
erectile dysfunction, (?%)
incontinence, (?%)
retrograde ejaculation, (?%)
urinary tract infection, (2.9%)
(acute) urinary retention, (9.5%)
hematuria, (6.8%)
rectorrhagia, (4.5%)
hematospermia, (5.8%)
stochastic en deterministic effects due to exposure of per-procedural X-ray.