None listed
Conditions
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
Interventions
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
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
Sponsors
Christchurch hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed