title: Efficacy and Safety of Rezūm System Water Vapor Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.
abstract: OBJECTIVE
  To assess 1-year efficacy and safety data from pilot trials of the Rezūm System water vapor to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
  
  
  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.
  
  
  CONCLUSIONS
  The Rezūm System provides effective relief of LUTS associated with BPH at 1 year. The procedure is safe with an acceptable side effect profile.
authors.affiliation: Department of Urology, Lenox Hill Hospital, New York, NY. Electronic address: cdixon3879@aol.com.
authors.forename: Christopher
authors.initials: C
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: Viteslav
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: Urologcentrum, Stockholm, Sweden.
authors.forename: Magnus
authors.initials: M
authors.lastname: Tornblom
authors.affiliation: Department of Urology, Mayo Clinic, Rochester, MN.
authors.forename: Lance
authors.initials: L
authors.lastname: Mynderse
authors.affiliation: Institute of Medical Research, Scottsdale, AZ.
authors.forename: Thayne
authors.initials: T
authors.lastname: Larson
mesh_terms: D000368:Aged; D016001:Confidence Intervals; D005500:Follow-Up Studies; D006801:Humans; D038622:Internationality; D053685:Laser Therapy / Q000295:instrumentation* / Q000379:methods; D059411:Lower Urinary Tract Symptoms / Q000209:etiology / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D061214:Patient Safety; D010865:Pilot Projects; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D020127:Recovery of Function; D018570:Risk Assessment; D012720:Severity of Illness Index; D020728:Transurethral Resection of Prostate / Q000379:methods*; D016896:Treatment Outcome; D014563:Urodynamics