Artery Embolization vs Operation of Benign Prostate Hyperplasia (NORTAPE)
Benign Prostatic Hyperplasia, Post-Op Complication, Embolization Therapeutic
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Prostate, Embolization, Complication, Operation, Randomization
Eligibility Criteria
Inclusion Criteria:
- LUTS from Benign Prostate Hyperplasia (BPH) with moderate and severe IPSS score (IPSS > 8) and QoL = or >3
- and refractory to medical treatment for at least 6 months or the patient is unwilling to accept medical treatment
- or BPH using permanent or intermittent catheterization
- Prostate volume > 50 ml
- Signed informed consent
Exclusion Criteria:
- Urological disorders: evidence of clinically significant prostate cancer [as defined by START criteria] on prostate biopsy (27,28), prostatitis (29,30), detrusor-sphincter dyssynergia or evidence of neurogenic bladder, urethral strictures, bladder neck contracture, bladder stone or bladder cancer
- Renal insufficiency defined as Glomerular Filtration Rate < 30 ml/min/1,73m2
- Known severe reactions to iodine-based contrast or gadolinium-based contrast
- Previous prostate operation
- CT examination reveals no access to the prostate arteries.
Sites / Locations
- Oslo University Hospital, AkerRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Prostate operation
Prostate artery embolization
You will have a surgery to remove the prostate gland. The surgery will be done during general anesthesia. If your prostate gland is small the surgery will be done through a catheter into the penis. If your prostate gland is large the surgery will be through an incision in your lower abdomen.
The embolization is done in the Department of Radiology. There will be placement of a catheter into the artery in one of the groins during local anesthesia. Through this catheter small particles will be injected into the arteries of the prostate gland. When finished, the hole in the artery will be closed.