Christopher Dixon1, Edwin Rijo Cedano2, Dalibor Pacik3, Viteslav Vit3, Gabriel Varga3, Lennart Wagrell4, Magnus Tornblom4, Lance Mynderse5, Thayne Larson6. 1. Department of Urology, Lenox Hill Hospital, New York, NY. Electronic address: cdixon3879@aol.com. 2. Department of Urology, Clinical Canela, La Romana, Dominican Republic. 3. Department of Urology, Brno University Hospital, Brno, Czech Republic. 4. Urologcentrum, Stockholm, Sweden. 5. Department of Urology, Mayo Clinic, Rochester, MN. 6. Institute of Medical Research, Scottsdale, AZ.
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). 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 Rezūm System provides effective relief of LUTS associated with BPH at 1 year. The procedure is safe with an acceptable side effect profile.
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 <.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 Rezūm System provides effective relief of LUTS associated with BPH at 1 year. The procedure is safe with an acceptable side effect profile.
Authors: Christopher M Dixon; Edwin Rijo Cedano; Dalibor Pacik; Vítězslav Vit; Gabriel Varga; Lennart Wagrell; Thayne R Larson; Lance A Mynderse Journal: Res Rep Urol Date: 2016-11-21