PMID- 26216644
OWN - NLM
STAT- MEDLINE
DCOM- 20160418
LR  - 20220410
IS  - 1527-9995 (Electronic)
IS  - 0090-4295 (Linking)
VI  - 86
IP  - 5
DP  - 2015 Nov
TI  - Efficacy and Safety of Rezum System Water Vapor Treatment for Lower Urinary Tract 
      Symptoms Secondary to Benign Prostatic Hyperplasia.
PG  - 1042-7
LID - S0090-4295(15)00698-6 [pii]
LID - 10.1016/j.urology.2015.05.046 [doi]
AB  - OBJECTIVE: To assess 1-year efficacy and safety data from pilot trials of the 
      Rezum System water vapor to treat lower urinary tract symptoms (LUTS) secondary 
      to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A total of 65 men 
      with symptoms of moderate to severe BPH were enrolled in pilot studies at centers 
      in the Dominican Republic, the Czech Republic, and Sweden. Each patient was 
      treated with transurethral delivery of sterile water vapor (steam). International 
      Prostate Symptom Score (IPSS), peak urinary flow (Qmax), quality of life (QoL), 
      postvoid residual, International Index of Erectile Function, and 
      prostate-specific antigen were evaluated at 1 week and 1, 3, 6, and 12 months 
      post-treatment. Safety was also assessed. RESULTS: Statistically significant 
      clinical improvements at 1, 3, 6, and 12 months were reported for IPSS (decreased 
      by 6.8, 13.4, 13.1, and 12.5 points, respectively) and Qmax (increased by 2.0, 
      4.7, 4.3, and 4.6 mL/sec, respectively). At 12 months, these results equated to a 
      56% improvement in IPSS (P <.001) and an 87% improvement in Qmax (P <.001). QoL 
      also improved at 12 months with a 61% improvement. Sexual function was 
      maintained. Most of the adverse events (AEs) were related to endoscopic 
      instrumentation and were of short duration. One case of urinary retention was 
      classified as a procedure/device-related serious AE. CONCLUSION: The Rezum System 
      provides effective relief of LUTS associated with BPH at 1 year. The procedure is 
      safe with an acceptable side effect profile.
CI  - Copyright (c) 2015 Elsevier Inc. All rights reserved.
FAU - Dixon, Christopher
AU  - Dixon C
AD  - Department of Urology, Lenox Hill Hospital, New York, NY. Electronic address: 
      cdixon3879@aol.com.
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, Viteslav
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 - Tornblom, Magnus
AU  - Tornblom M
AD  - Urologcentrum, Stockholm, Sweden.
FAU - Mynderse, Lance
AU  - Mynderse L
AD  - Department of Urology, Mayo Clinic, Rochester, MN.
FAU - Larson, Thayne
AU  - Larson T
AD  - Institute of Medical Research, Scottsdale, AZ.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20150726
PL  - United States
TA  - Urology
JT  - Urology
JID - 0366151
SB  - IM
MH  - Aged
MH  - Confidence Intervals
MH  - Follow-Up Studies
MH  - Humans
MH  - Internationality
MH  - Laser Therapy/*instrumentation/methods
MH  - Lower Urinary Tract Symptoms/etiology/physiopathology/*surgery
MH  - Male
MH  - Middle Aged
MH  - Minimally Invasive Surgical Procedures/methods
MH  - Patient Safety
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Prostatic Hyperplasia/complications/diagnosis/*surgery
MH  - Recovery of Function
MH  - Risk Assessment
MH  - Severity of Illness Index
MH  - Transurethral Resection of Prostate/*methods
MH  - Treatment Outcome
MH  - Urodynamics
EDAT- 2015/07/29 06:00
MHDA- 2016/04/19 06:00
CRDT- 2015/07/29 06:00
PHST- 2015/02/05 00:00 [received]
PHST- 2015/05/14 00:00 [revised]
PHST- 2015/05/22 00:00 [accepted]
PHST- 2015/07/29 06:00 [entrez]
PHST- 2015/07/29 06:00 [pubmed]
PHST- 2016/04/19 06:00 [medline]
AID - S0090-4295(15)00698-6 [pii]
AID - 10.1016/j.urology.2015.05.046 [doi]
PST - ppublish
SO  - Urology. 2015 Nov;86(5):1042-7. doi: 10.1016/j.urology.2015.05.046. Epub 2015 Jul 
      26.