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Trial registered on ANZCTR


Registration number
ACTRN12617001235392
Ethics application status
Approved
Date submitted
4/08/2017
Date registered
24/08/2017
Date last updated
24/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Prostate Artery Embolization for patients with lower urinary tract symptoms due to benign prostate hyperplasia
Scientific title
Efficacy of Prostate Artery Embolization for patients with lower urinary tract symptoms due to benign prostate hyperplasia
Secondary ID [1] 292593 0
none
Universal Trial Number (UTN)
Trial acronym
PRO-FLOW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
benign prostate hyperplasia 304271 0
lower urinary tract symptoms 304272 0
Condition category
Condition code
Renal and Urogenital 303618 303618 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prostate Artery Embolization. This procedure is performed as a day case in Interventional Radiology under conscious sedation using fluoroscopy. A very small urinary catheter is placed into the bladder and filled with contrast medium. The prostate artery is accessed using the Seldinger technique into CFA. Guidewires and catheters are introduced through the sheath and Embozene microspheres are injected into the left and right side of the prostate artery. The procedure takes approximately one hour and is performed by a specialist Interventional Radiologist. The catheter is removed 4 hours post procedure and the patient is discharged home
Intervention code [1] 298805 0
Treatment: Devices
Intervention code [2] 298806 0
Treatment: Surgery
Comparator / control treatment
TURP group. This is the gold standard treatment for benign prostatic hyperplasia. It involves pre admission checks, ECG and anaesthetic assessment, bloods for CBC, renal, LFT and group and hold. The patient has TURP under either general or spinal anaesthetic and the procedure can take 1 -3 hours. There is significant post operative discomfort. Usually the patient has a 3-4 day hospital stay with a large urinary catheter, bladder irrigations. Patients can be discharged without or with a catheter in situ if unsuccessful trial of void immediately post op
Control group
Active

Outcomes
Primary outcome [1] 302975 0
Change in IPSS after 3 months
Timepoint [1] 302975 0
3 months
Primary outcome [2] 302976 0
Successful trial of voiding after removal catheter means being able to pass urine effectively and empty bladder completely. Good stream and the ability to start and stop flow
Timepoint [2] 302976 0
6 weeks
Secondary outcome [1] 337602 0
patient satisfaction evaluations as assessed by the IPSS
Timepoint [1] 337602 0
6 weeks , 6, 12, 24 and 60 months

Eligibility
Key inclusion criteria
Willing, able and mentally competent to provide written consent
aged 40 years or older
lower urinary tract symptoms
IPSS > 8
QOL >3
Prostate gland >40g on transabdominal ultrasound
Vascular anatomy that in the opinion of the Interventional Radiologist is amenable to PAE as assessed on CTA
Adequate laboratory parameters: platelets >100 , INR <1.5, bilirubin <2, albumen >2.5, eGFR >60
Minimum age
40 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Prior history of prostate surgery or TURP
prior radiation to the pelvis
prior embolization to the prosatate
acontractile detrusor
neurogenic lower urinary tract dysfunction
urethral stenosis
bladder stone with surgical indication
proven adenocarcinoma of the prostate
eGFR <50ml/min
complicated anatomical variant including prostate artery
ASA class 4-5
contrast allergy
significant psychiatric disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
numbers of patients recruited are based on a power calculation. For the primary endpoint, changes in IPSS at 3 months will be compared using a one sided t-test with significance level 2.5%. A non-inferiority margin has been set aside at -3. The targeted standard deviation was estimated at 3.5. If there is truly no difference between the TURP and PAE in terms of the improvement in IPSS score, the 44 patients (22 in each arm) are required to be 80% sure that the lower limit of a one sided 97.5% confidence interval (or equivalency a 95% two-sided interval) will be above the non-inferiority limit of -3.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9126 0
New Zealand
State/province [1] 9126 0

Funding & Sponsors
Funding source category [1] 297172 0
Hospital
Name [1] 297172 0
Christchurch hospital
Address [1] 297172 0
2 Riccarton Avenue
Christchurch 8011
New Zealand
Country [1] 297172 0
New Zealand
Primary sponsor type
Hospital
Name
Christchurch hospital
Address
2 Riccarton Avenue
Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 296190 0
None
Name [1] 296190 0
Address [1] 296190 0
Country [1] 296190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298340 0
Health and Disability Ethics Committees
Ethics committee address [1] 298340 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO box 5013
Wellington 6011
Ethics committee country [1] 298340 0
New Zealand
Date submitted for ethics approval [1] 298340 0
01/06/2015
Approval date [1] 298340 0
28/08/2015
Ethics approval number [1] 298340 0
15/STH?119

Summary
Brief summary
The purpose of this trial is to evaluate the safety and effectiveness of percutaneous embolization of the prostate arteries as a minimally invasive image guided procedure for patients with lower urinary tract symptoms due to benign prostate hyperplasia with a prostate volume of more than 40g. Benign prostate hyperplasia is a significant health problem in New Zealand affecting over 50% of men older than 60 years. This leads to lower urinary symptoms (LUTS) eg weak urine stream, urgency and leaking and even acute urinary retention. Symptoms are initially treated with medication but many patient do need surgical intervention. Transurethral resection of the prostate (TURP) is the standard treatment for prostates smaller than 80g whereas larger prostates may require open surgical resection. Both operations are not without risk and many elderly patients are not good candidates for surgery. Percutaneous embolization of bilateral prostate arteries aims to mimic the effect of TURP or open resection of the prostate without exposing the patients to the risk of operation and anaesthesia. PAE decrease the blood supply to the prostate gland and causes the gland to shrink. This trial aims to assess the safety and efficacy of PAE and in the future offer patients another treatment option for BPH
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76766 0
Dr Martin Krauss
Address 76766 0
Radiology Department
Christchurch hospital
2 Riccarton Avenue
Christchurch 8011
Country 76766 0
New Zealand
Phone 76766 0
+64 3 3641410
Fax 76766 0
+64 3 3641893
Email 76766 0
martin.krauss@cdhb.health.nz
Contact person for public queries
Name 76767 0
Dr Martin Krauss
Address 76767 0
Radiology Department
Christchurch Hospital
2 Riccarton Avenue
Christchurch 8011
Country 76767 0
New Zealand
Phone 76767 0
+64 3 3641410
Fax 76767 0
+64 3 3641893
Email 76767 0
martin.krauss@cdhb.health.nz
Contact person for scientific queries
Name 76768 0
Dr Martin Krauss
Address 76768 0
Radiology Department
Christchurch Hospital
2 Riccarton Avenue
Christchurch 8011
Country 76768 0
New Zealand
Phone 76768 0
+64 3 3641810
Fax 76768 0
+64 3 3641893
Email 76768 0
mertin.krauss@cdhb.health.nz

No data has been provided for results reporting
Summary results
Not applicable