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).
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
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.
Urology. 2015 Jul 26 [Epub]
Christopher Dixon, Edwin Rijo Cedano, Dalibor Pacik, Viteslav Vit, Gabriel Varga, Lennart Wagrell, Magnus Tornblom, Lance Mynderse, Thayne Larson
Department of Urology, Lenox Hill Hospital, New York, NY. Department of Urology, Clinical Canela, La Romana, Dominican Republic. , Department of Urology, Brno University Hospital, Brno, Czech Republic. , Department of Urology, Brno University Hospital, Brno, Czech Republic. , Department of Urology, Brno University Hospital, Brno, Czech Republic. , Urologcentrum, Stockholm, Sweden. , Urologcentrum, Stockholm, Sweden. , Department of Urology, Mayo Clinic, Rochester, MN. , Institute of Medical Research, Scottsdale, AZ.