title: Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia.
abstract: OBJECTIVE
  The objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations.
  
  
  METHODS
  Men aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Qmax) ≤15 mL/s, and prostate volume 20-120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden. The transurethral thermal therapy utilizes radiofrequency to generate wet thermal energy in the form of water vapor injected through a rigid endoscope into the lateral lobes and median lobe as needed. Urinary symptom relief, urinary flow, quality of life (QOL) impact, sexual function, and adverse events (AEs) were assessed at 1 week, 1, 3, 6, 12, and 24 months.
  
  
  RESULTS
  LUTS, flow rate, and QOL showed significant improvements from baseline; prostate volumes were appreciably reduced. Sexual function was maintained and node novoerectile dysfunction occurred. The responses evident as early as 1 month after treatment remained consistent and durable over the 24 months of study. Early AEs were typically transient and mild to moderate; most were related to endoscopic instrumentation. No procedure related to late AEs were seen.
  
  
  CONCLUSIONS
  The Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which can be performed in the office or as an outpatient procedure with minimal associated perioperative AEs. It has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years.
authors.affiliation: Department of Urology, Phelps Memorial Hospital, Sleepy Hollow, New York, NY, USA.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Dixon
authors.affiliation: Department of Urology, Clinical Canela, La Romana, Dominican Republic.
authors.forename: Edwin Rijo
authors.initials: ER
authors.lastname: Cedano
authors.affiliation: Department of Urology, Brno University Hospital, Brno, Czech Republic.
authors.forename: Dalibor
authors.initials: D
authors.lastname: Pacik
authors.affiliation: Department of Urology, Brno University Hospital, Brno, Czech Republic.
authors.forename: Vítězslav
authors.initials: V
authors.lastname: Vit
authors.affiliation: Department of Urology, Brno University Hospital, Brno, Czech Republic.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Varga
authors.affiliation: Urologcentrum, Stockholm, Sweden.
authors.forename: Lennart
authors.initials: L
authors.lastname: Wagrell
authors.affiliation: Institute of Medical Research, Scottsdale, AZ.
authors.forename: Thayne R
authors.initials: TR
authors.lastname: Larson
authors.affiliation: Department of Urology, Mayo Clinic, Rochester, MN, USA.
authors.forename: Lance A
authors.initials: LA
authors.lastname: Mynderse
keywords: benign prostatic hyperplasia; convective RF; lower urinary tract symptoms; minimally invasive; water vapor thermal therapy