用于治疗尿道狭窄疾病的Urolume尿道内假体：北美多中心Urolume试验的长期结果
Urolume endourethral prosthesis for the treatment of urethral stricture disease: long-term results of the North American Multicenter UroLume Trial.
作者信息
Badlani G H, Press S M, Defalco A, Oesterling J E, Smith A D
机构信息
Department of Urology, Long Island Jewish Medical Center, New Hyde Park, New York, USA.
出版信息
Urology. 1995 May;45(5):846-56. doi: 10.1016/s0090-4295(99)80093-4.
OBJECTIVES
To evaluate the long-term results of the UroLume endourethral prosthesis for the treatment of recurrent bulbar urethral strictures.
METHODS
In a multicenter, prospective study 175 patients with recurrent bulbar urethral strictures were enrolled in a Food and Drug Administration (FDA) trial of the UroLume endourethral prosthesis. One hundred thirty-nine patients were available for follow-up at 1 year, and 81 patients were available for follow-up at 2 years.
RESULTS
Clinically and statistically significant results were seen at 1 year and sustained at 2 years. Re-treatment rate was down from 75.2% preinsertion to 14.3% 1 year postinsertion of the prosthesis. Explantation was required in only 3% of patients.
CONCLUSIONS
Based on these and European data, the UroLume endourethral prosthesis offers a significant advantage over the currently available treatments for recurrent bulbar urethral strictures.
目的
评估UroLume尿道内假体治疗复发性球部尿道狭窄的长期效果。
方法
在一项多中心前瞻性研究中，175例复发性球部尿道狭窄患者参加了美国食品药品监督管理局（FDA）关于UroLume尿道内假体的试验。139例患者可进行1年随访，81例患者可进行2年随访。
结果
在1年时观察到临床和统计学上的显著效果，并在2年时持续存在。再治疗率从植入假体前的75.2%降至植入后1年的14.3%。仅3%的患者需要取出假体。
结论
基于这些数据和欧洲的数据，UroLume尿道内假体相对于目前可用的复发性球部尿道狭窄治疗方法具有显著优势。
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