Artery Embolization vs Operation of Benign Prostate Hyperplasia

Recruiting now · Not applicable

Conditions studied: Benign Prostatic Hyperplasia, Post-Op Complication, Embolization Therapeutic, Transurethral Resection of Prostate Syndrome

In brief

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.

Key facts

Study ID

NCT04084938

Run by

Oslo University Hospital

People needed

140

Starts

2019-09-01

Expected to finish

2027-12-31

Last updated by the study team

2023-12-27

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Oslo University Hospital, Aker — Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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