Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001201369
Ethics application status
Approved
Date submitted
9/08/2017
Date registered
16/08/2017
Date last updated
16/06/2023
Date data sharing statement initially provided
27/03/2019
Date results information initially provided
20/09/2019
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
None
Universal Trial Number (UTN)
U1111-1200-4913
Trial acronym
U P-EASY PLUS
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

Intervention/exposure
Study type
Interventional
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
Uncontrolled

Outcomes
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

Eligibility
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
Sex
Males
Can healthy volunteers participate?
No
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
Treatment
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/03/2017
Date of last participant enrolment
Anticipated
1/01/2020
Actual
3/03/2021
Date of last data collection
Anticipated
25/11/2022
Actual
22/04/2022
Sample size
Target
120
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
QLD
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
Country [1] 297254 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Wesley Medical Imaging
Address
Wesley Medical Imaging
The Wesley Hospital
30 Chasely Street
Auchenflower, QLD, 4066
Country
Australia
Secondary sponsor category [1] 296225 0
None
Name [1] 296225 0
None
Address [1] 296225 0
None
Country [1] 296225 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 298373 0
Approval date [1] 298373 0
16/02/2017
Ethics approval number [1] 298373 0
1520

Summary
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

Contacts
Principal investigator
Name 76866 0
Dr Nicholas Brown
Address 76866 0
Wesley Medical Imaging
30 Chasley St
Auchenflower
QLD 4065
Country 76866 0
Australia
Phone 76866 0
+61 7 33719588
Fax 76866 0
Email 76866 0
[email protected]
Contact person for public queries
Name 76867 0
Dr Sepinoud Firouzmand
Address 76867 0
Wesley Medical Imaging
30 Chasley St
Auchenflower
QLD 4065
Country 76867 0
Australia
Phone 76867 0
+61 7 33719588
Fax 76867 0
Email 76867 0
[email protected]
Contact person for scientific queries
Name 76868 0
Dr Sepinoud Firouzmand
Address 76868 0
Wesley Medical Imaging
30 Chasley St
Auchenflower
QLD 4065
Country 76868 0
Australia
Phone 76868 0
+61 7 33719588
Fax 76868 0
Email 76868 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12491Ethical approval    373452-(Uploaded-28-01-2021-08-45-35)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIProstate artery Embolisation Assessment of Safety and feasibilitY (P-EASY): a potential alternative to long-term medical therapy for benign prostate hyperplasia2018https://doi.org/10.1111/bju.14504
N.B. These documents automatically identified may not have been verified by the study sponsor.