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. 2021 Jul 15;2021(7):CD013656. doi: 10.1002/14651858.CD013656.pub2

NCT04236687.

Study name PAE compared to Holmium laser enucleation of the prostate for BPH
Methods Study design: parallel randomized controlled trial (open label)
Setting/Country: single center / Spain
Participants Inclusion criteria
Patients evaluated in the urology department and candidates to surgical treatment
  • Age > 45 years

  • IPSS ≥ 10

  • Qmax < 12 mL/s

  • PVR < 300 mL

  • Prostatic volume between 20 mL and 250 mL assessed by ultrasound

  • Signed informed consent

Interventions Group A: PAE
Group B: Holmium laser enucleation of the prostate
Outcomes Primary outcome
  • Improvement of symptoms assessed by IPSS


Secondary outcomes
  • Qmax

  • PVR

  • PSA

  • Procedure related adverse events assessed by Clavien‐Dindo modified score

  • Procedure related effects on sexual function assessed by IIEF

  • Procedure related effects on urinary continence assessed by the International Consultation on Continence Questionnaire Short Form

Starting date February 2020
Contact information fagreda.germanstrias@gencat.cat
Notes Sponsor: Hospital Universitari Germans Trias i Pujol