Artery Embolization vs Operation of Benign Prostate Hyperplasia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorOslo University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Prostate operation or prostate artery embolization

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators