NCT02566551.

Study name	Prospective controlled randomized study of PAE vs TURP for BPH treatment
Methods	Study design: single (outcome assessor) blinded parallel randomized controlled trial Setting/Country: single center / Spain
Participants	Inclusion criteria: Patients evaluated in the Urology Service because of BPH, candidate to TURP. Signed informed consent LUTS secondary to BPH for at least 6 months prior to study and/or baseline IPSS score > 13 and/or acute urinary retention with impossibility to remove urinary catheter and/or BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused prostate size of at least 50 grams measured by MRI Patient must meet one of the following criteria: baseline PSA < 4 ng/mL (no prostate biopsy required), baseline PSA > 4 ng/mL and ≤ 10 ng/mL and free PSA > 15% of total PSA (no prostate biopsy required), baseline PSA > 4 ng/mL and ≤ 10 ng/mL and free PSA < 15% of total PSA and a negative prostate biopsy result (minimum 12 core biopsy), baseline PSA > 10 ng/mL and a negative prostate biopsy (minimum 12 core biopsy)
Interventions	Group A: PAE Group B: TURP
Outcomes	Primary outcome Improvement of symptoms assessed by IPSS score Secondary outcomes Improvement in QoL Duration of hospitalization post procedure Preservation of erectile function using the IIEF Other outcomes Change from baseline in Qmax Change from baseline in PVR Change from baseline in detrusor pressure Change from baseline in mean prostate volume, as determined by transrectal ultrasound Structural and morphological changes in MRI Change from baseline in PSA Overall adverse events Procedure related adverse events
Starting date	October 2015
Contact information	mgregori@unizar.es
Notes	This study is currently recruiting participants. Sponsor: Group of Research in Minimally Invasive Techniques Hospital Clínico Universitario Lozano Blesa Universidad de Zaragoza