医学
下尿路症状
国际前列腺症状评分
不利影响
生活质量(医疗保健)
泌尿科
泌尿系统
增生
前列腺
性功能
内科学
护理部
癌症
作者
Christopher Dixon,Edwin Rijo Cedano,Dalibor Pacík,Viteslav Vit,Gabriel Varga,Lennart Wagrell,Magnus Törnblom,Lance A. Mynderse,Thayne R. Larson
出处
期刊:Urology
[Elsevier]
日期:2015-11-01
卷期号:86 (5): 1042-1047
被引量:79
标识
DOI:10.1016/j.urology.2015.05.046
摘要
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).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.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.The Rezūm System provides effective relief of LUTS associated with BPH at 1 year. The procedure is safe with an acceptable side effect profile.
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