PMID- 27921028
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220410
IS  - 2253-2447 (Print)
IS  - 2253-2447 (Electronic)
IS  - 2253-2447 (Linking)
VI  - 8
DP  - 2016
TI  - Two-year results after convective radiofrequency water vapor thermal therapy of 
      symptomatic benign prostatic hyperplasia.
PG  - 207-216
AB  - 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. PATIENTS AND METHODS: Men 
      aged >/=45 years with an International Prostate Symptom Score >/=13, a maximum 
      urinary flow rate (Q(max)) </=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 Rezum 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 no de novo 
      erectile 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. CONCLUSION: The 
      Rezum 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.
FAU - Dixon, Christopher M
AU  - Dixon CM
AD  - Department of Urology, Phelps Memorial Hospital, Sleepy Hollow, New York, NY, 
      USA.
FAU - Cedano, Edwin Rijo
AU  - Cedano ER
AD  - Department of Urology, Clinical Canela, La Romana, Dominican Republic.
FAU - Pacik, Dalibor
AU  - Pacik D
AD  - Department of Urology, Brno University Hospital, Brno, Czech Republic.
FAU - Vit, Vitezslav
AU  - Vit V
AD  - Department of Urology, Brno University Hospital, Brno, Czech Republic.
FAU - Varga, Gabriel
AU  - Varga G
AD  - Department of Urology, Brno University Hospital, Brno, Czech Republic.
FAU - Wagrell, Lennart
AU  - Wagrell L
AD  - Urologcentrum, Stockholm, Sweden.
FAU - Larson, Thayne R
AU  - Larson TR
AD  - Institute of Medical Research, Scottsdale, AZ.
FAU - Mynderse, Lance A
AU  - Mynderse LA
AD  - Department of Urology, Mayo Clinic, Rochester, MN, USA.
LA  - eng
PT  - Journal Article
DEP - 20161121
PL  - England
TA  - Res Rep Urol
JT  - Research and reports in urology
JID - 101576971
PMC - PMC5123707
OTO - NOTNLM
OT  - benign prostatic hyperplasia
OT  - convective RF
OT  - lower urinary tract symptoms
OT  - minimally invasive
OT  - water vapor thermal therapy
COIS- Christopher M Dixon and Thayne R Larson have consulted with NxThera in the 
      clinical trial design. Lennart Wagrell has served as a consultant to NxThera for 
      other projects. The authors report no other conflicts of interest in this work.
EDAT- 2016/12/07 06:00
MHDA- 2016/12/07 06:01
PMCR- 2016/11/21
CRDT- 2016/12/07 06:00
PHST- 2016/12/07 06:00 [entrez]
PHST- 2016/12/07 06:00 [pubmed]
PHST- 2016/12/07 06:01 [medline]
PHST- 2016/11/21 00:00 [pmc-release]
AID - rru-8-207 [pii]
AID - 10.2147/RRU.S119596 [doi]
PST - epublish
SO  - Res Rep Urol. 2016 Nov 21;8:207-216. doi: 10.2147/RRU.S119596. eCollection 2016.