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Artery Embolization vs Operation of Benign Prostate Hyperplasia

RecruitingNAAges any - anyMaleOslo University Hospital
NCT04084938 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
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.
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What it tests

  • Prostate operation or prostate artery embolization
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Where

1 site
Oslo University Hospital, Aker
Oslo, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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