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.
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
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
Parallel
Prostate operation or prostate artery embolization
Procedure/SurgeryAs described above.
Quality of life due to urinary symptoms
"Quality of life due to urinary symptoms" QoL = or \<3 The scale used: Quality of Life Due to Urinary Symptoms. Scale from 0 to 6, the worse is 6. The patient question: If you were to spend the rest of Your life With Your urinary condition just the way it is now, how would you feel about that?
Number of patients with Prostate Artery Embolization that did not have prostate operation
The investigators will record the number of patients that did not have prostate surgery after Prostate Artery Embolization. After 3 months the patients will be offered operation when Quality of Life Due to Urinary Symptoms is 4-6 on the scale from 0-6 ie. the patients report unsatisfied (4), unhappy (5) or terrible (6).
Number of patients with postoperative complications
Postoperative complications will be recorded according to the Clavien-Dindo classification system. Complication will be recorded during hospital stay, at the follow-up after 3 months and at any intermediate points reported by the patients
Hospital stay
Length of stay including before and after the intervention
Symptoms
Change in IPSS. The patients fill in the form International Prostate Symptom Score (IPSS) before and after treatment. Seven questions are scored from 0 to 5, 5 is the worst outcome. Total score from 0 - 35. 1-7 is mild symptoms, 8-19 is moderate symptoms, 20-35 is severe symptoms.
Need for catheters
Number of patients using permanent and intermittent catheters at follow-up will be recorded
Erectile function
Change in erectile function will be recoded using the International Index of Erectile Function (IIEF-5) questionnaire. The patients fill in the form before and after treatment. There are 5 questions which score 1-5, 5 is the best. Total score from 5-25.
Ejaculation
Change in ejaculation will be recorded using the Male Sexual Questionnaire short form for assessing ejaculation. There are 4 questions with 5-6 possible outcomes.
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