Artery Embolization vs Operation of Benign Prostate Hyperplasia
Artery Embolization vs Operation of Benign Prostate Hyperplasia
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.
Background: Prostatic artery embolization (PAE) has recently been described as a promising
 alternative to surgery for treatment of lower urinary tract symptoms (LUTS) due to an
 enlarged, benign prostate. The treatment has not been implemented into international
 guidelines and has only been introduced to few patients in Norway.

 Purpose: To compare 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.

 Materials and Methods: 140 patients will be randomized to PAE or surgery. Patients should
 suffer from 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 injection small particles into the
 prostate arteries. The surgery is done in the operation room in the urology department
 according to established procedures. All patients stay in the urology unit after the
 procedure. Clinical follow-up include clinical visit after 3 months, 1 and 5 years. Acute as
 well as long term complications will be recorded. The patients fill in the form of quality of
 life from urologic disease. Urodynamic examination will record functional outcome. Length of
 stay, procedure costs and recovery time will be recorded.

 Importance of the study: Contribute to establishment of new treatment and help to select the
 right patients for the alternative treatments. Randomized study will give important
 information to the international community. It is possible to run this study in Norway
 because it is still in limited use.
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.