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Prostate Artery Embolisation Assessment of Safety and Efficacy with preliminary and follow-up urodynamic studies (P-EASY PLUS)

Prostate Artery Embolisation Assessment of Safety and Efficacy with preliminary and follow-up urodynamic studies in men with symptomatic benign prostate hyperplasia (P-EASY PLUS)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001201369
Acronym
U P-EASY PLUS
Enrollment
105
Registered
2017-08-16
Start date
2017-03-14
Completion date
2021-03-03
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Prostate artery embolisation (PAE) is an emerging, minimally invasive treatment for lower urinary tract symptoms caused by benign prostate enlargement. The first prospective trial of PAE in Australia was performed at The Wesley Hospital, and this project builds on those successful results. Whilst PAE was shown to be very effective at shrinking the prostate and relieving urinary tract symptoms during short-term follow-up, its impact on urodynamics, and the complex interplay between prostate obstruction and bladder function, is yet to be studied. This project aims to be the first study to comprehensively assess the impact of PAE on bladder function (urodynamics), as well as improvements in urinary symptoms and quality of life. The study will also compare the responses of patients with differing severity of prostate enlargement, and those with recurrent symptoms after a surgical resection. This information will be used to hopefully predict which patients are likely to best respond to a PAE, and can therefore be considered as an alternative to medical therapy or as an effective medium term precursor to more invasive surgical resection.

Interventions

Prostate artery embolisation procedures are performed by interventional radiologists experienced in prostate artery embolisation. The procedure takes approximately 120 minutes. Procedures will be performed with a right femoral or left brachial artery approach, using 4- or 5- French sheaths. 5-Fr 125 cm Impulse (Merit Medical, Utah, USA) and 4-Fr 120 cm Cobra Glidecath (Terumo, New Jersey, USA) catheters are combined with 150 cm standard Glidewires (Terumo, New Jersey, USA) to access the internal

Prostate artery embolisation procedures are performed by interventional radiologists experienced in prostate artery embolisation. The procedure takes approximately 120 minutes. Procedures will be performed with a right femoral or left brachial artery approach, using 4- or 5- French sheaths. 5-Fr 125 cm Impulse (Merit Medical, Utah, USA) and 4-Fr 120 cm Cobra Glidecath (Terumo, New Jersey, USA) catheters are combined with 150 cm standard Glidewires (Terumo, New Jersey, USA) to access the internal iliac arteries. Microcatheters 2.0Fr Progreat (Terumo, New Jersey, USA) or 1.7Fr SL-10 (Stryker, Michigan, USA) are used to selectively catheterise the prostate arteries over microwires, either 0.016” Radifocus Guidewire GT (Terumo, New Jersey, USA) or 0.014” Synchro Standard (Stryker, Michigan, USA). Following selective catheterisation of the prostate arteries and positioning of the microcatheter tip within the distal prostate artery, an on-table Dyna CT scan using hand-injected 1-2 ml contrast (Ultravist 300, Bayer, Leverkusen, Germany) in a 3 ml Medallion syringe (Merit Medical, Utah, USA) is performed and reviewed in three planes to assess for non-prostatic enhancement. Once the operators are confident that no off-target enhancement is evident, a single unit syringe of 250 micron Embozene (Celenova Biosciences, Texas, USA) is prepared by diluting the Embozene particles with full contrast to 1/16 (6.25%) of the original concentration. Embolisation is then performed by slowly injecting the diluted particles until complete stasis of the prostate artery has been achieved.

Sponsors

Wesley Medical Imaging
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
Male
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

BPH with prostate volume > 40cc Moderate-severe lower urinary tract symptoms (IPSS >8) Peak urinary flow <12ml/sec Obstructive urodynamics Medically refractory lower urinary tract symptoms >6 months Unsuitable for, or unwilling to undergo, surgical prostate resection, in consultation with a urological surgeon

Exclusion criteria

Prostate malignancy Neurogenic bladder Renal failure eGFR <35ml/min Severe contrast allergy Severe peripheral vascular disease Urethral or bladder pathology

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026