NCT04084938.

Study name	Artery embolization vs operation of benign prostate hyperplasia (NORTAPE)
Methods	Study design: parallel randomized controlled trial (open label) Setting/country: single center/Norway
Participants	Inclusion criteria: LUTS from BPH with moderate and severe IPSS score (IPSS > 8) and QoL ≥ 3; refractory to medical treatment for ≥ 6 months or the patient is unwilling to accept medical treatment; BPH using permanent or intermittent catheterization; prostate volume > 50 mL; signed informed consent
Interventions	Group A: PAE Group B: prostate operation through a catheter into the penis or through an incision in lower abdomen
Outcomes	Primary outcome QoL Retreatment Secondary outcomes Postoperative complications Hospital stay IPSS Need for catheters Erectile function Ejaculation
Starting date	September 2019
Contact information	fagreda.germanstrias@gencat.cat
Notes	Sponsor: Oslo University Hospital