Please note the ANZCTR will be unattended from Friday 24 December 2021 for the holidays. The Registry will re-open on Monday 17 January 2022. Submissions and updates will not be processed during that time.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prostate Artery Embolisation Assessment of Safety and Efficacy with preliminary and follow-up urodynamic studies (P-EASY PLUS)
Scientific title
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)
Secondary ID [1] 292625 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign prostate hyperplasia 304319 0
Condition category
Condition code
Renal and Urogenital 303676 303676 0 0
Other renal and urogenital disorders
Surgery 303685 303685 0 0
Surgical techniques

Study type
Description of intervention(s) / exposure
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.
Intervention code [1] 298851 0
Treatment: Other
Intervention code [2] 298859 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group

Primary outcome [1] 303037 0
Assessment of bladder function following a PAE as assessed by urodynamic studies. A urodynamic study (or bladder pressure study) is performed by a urologist using a computer which monitors the pressure in the bladder via a pressure transducer inserted in the rectum. There a two phases to the test; during the filling phase a sterile liquid is trickled into the bladder by a catheter; in the second phase, the liquid is voided by the patient. Throughout the process the pressure within the bladder is measured, in addition to sensation felt by the patient, flow rate of void and residual volume following void.
Timepoint [1] 303037 0
12-months post procedure
Primary outcome [2] 303038 0
Association between initial prostate volume (calculated based on average measurements by CT, MRI and ultrasound) and urodynamic outcomes (bladder pressure during filling and void, void flow rate and residual volume following void, as assessed by urodynamic studies) following a PAE

Timepoint [2] 303038 0
12-months post-procedure
Primary outcome [3] 303039 0
Change in severity of symptoms following a PAE as assessed by the international prostate symptom severity (IPSS) score
Timepoint [3] 303039 0
3-months and 12-months post procedure
Secondary outcome [1] 337742 0
Change in quality of life score following a PAE as assessed within the IPSS questionnaire
Timepoint [1] 337742 0
3-months and 12-months post procedure
Secondary outcome [2] 337785 0
Change in the need for medication use to treat lower urinary tract symptoms following a PAE, as assessed by a follow-up questionnaire designed specifically for this study
Timepoint [2] 337785 0
3-months and 12-months post procedure

Key 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
Minimum age
50 Years
Maximum age
80 Years
Can healthy volunteers participate?
Key exclusion criteria
Prostate malignancy
Neurogenic bladder
Renal failure eGFR <35ml/min
Severe contrast allergy
Severe peripheral vascular disease
Urethral or bladder pathology

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 8751 0
The Wesley Hospital - Auchenflower
Recruitment hospital [2] 8752 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment postcode(s) [1] 16871 0
4066 - Auchenflower
Recruitment postcode(s) [2] 16872 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 297254 0
Commercial sector/Industry
Name [1] 297254 0
Wesley Medical Imaging
Address [1] 297254 0
Wesley Medical Imaging
The Wesley Hospital
30 Chasely Street
Auchenflower, QLD, 4066
Country [1] 297254 0
Primary sponsor type
Commercial sector/Industry
Wesley Medical Imaging
Wesley Medical Imaging
The Wesley Hospital
30 Chasely Street
Auchenflower, QLD, 4066
Secondary sponsor category [1] 296225 0
Name [1] 296225 0
Address [1] 296225 0
Country [1] 296225 0

Ethics approval
Ethics application status
Ethics committee name [1] 298373 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 298373 0
UnitingCare Health Human Research Ethics Committee
The Wesley Hospital
PO Box 499
Auchenflower Qld 4066
Ethics committee country [1] 298373 0
Date submitted for ethics approval [1] 298373 0
Approval date [1] 298373 0
Ethics approval number [1] 298373 0

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 76866 0
Dr Nicholas Brown
Address 76866 0
Wesley Medical Imaging
30 Chasley St
QLD 4065
Country 76866 0
Phone 76866 0
+61 7 33719588
Fax 76866 0
Email 76866 0
Contact person for public queries
Name 76867 0
Dr Rhiannon McBean
Address 76867 0
Wesley Medical Imaging
30 Chasley St
QLD 4065
Country 76867 0
Phone 76867 0
+61 7 33719588
Fax 76867 0
Email 76867 0
Contact person for scientific queries
Name 76868 0
Dr Rhiannon McBean
Address 76868 0
Wesley Medical Imaging
30 Chasley St
QLD 4065
Country 76868 0
Phone 76868 0
+61 7 33719588
Fax 76868 0
Email 76868 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 12491 0
Ethical approval
Citation [1] 12491 0
Link [1] 12491 0
Email [1] 12491 0
Other [1] 12491 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary