Actively Recruiting
Artery Embolization vs Operation of Benign Prostate Hyperplasia
Led by Oslo University Hospital · Updated on 2023-12-27
140
Participants Needed
1
Research Sites
434 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Aim of the study is to compare prostate artery embolization (PAE) to the established surgical treatment for patient acceptance, morbidity, complications, and the functional outcomes. To compare length of stay, hospital costs and time for recovery. 140 patients will be randomized to PAE or surgery. Patients should suffer from lower urinary tract symptoms (LUTS), be candidates for both treatments and willing to undergo both procedures. Before randomization computed tomography angiography of the pelvic arteries is done to select eligible patients. Magnetic resonance imaging of prostate rules out possible cancer. The PAE is done in the angio suite in the radiology department injecting small particles into the prostate arteries. The surgery is done in the operation room in the urology department according to established procedures. Clinical follow-up include clinical visit after 3 months, 1 and 5 years. Acute as well as long term complications will be recorded.
CONDITIONS
Official Title
Artery Embolization vs Operation of Benign Prostate Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate to severe lower urinary tract symptoms from benign prostate enlargement with IPSS score greater than 8 and quality of life score 3 or higher
- Symptoms refractory to medical treatment for at least 6 months or patient unwilling to use medical treatment
- Use of permanent or intermittent catheterization due to benign prostate enlargement
- Prostate volume greater than 50 ml
- Signed informed consent to participate
You will not qualify if you...
- Evidence of significant prostate cancer based on biopsy
- Prostatitis, neurogenic bladder conditions, urethral strictures, bladder neck contracture, bladder stones, or bladder cancer
- Kidney failure with glomerular filtration rate below 30 ml/min/1.73m2
- Known severe allergy to iodine-based or gadolinium-based contrast agents
- Previous prostate surgery
- Computed tomography shows no access to prostate arteries for embolization
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital, Aker
Oslo, Norway
Actively Recruiting
Research Team
T
Thijs Hagen, MD
CONTACT
E
Eduard Baco, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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