Department of Urology, Stanford University Medical School, Stanford, CA.
Department of Urology, Kaiser Permanente Medical Group, San Diego, CA.
Urology. 2014 Aug;84(2):433-8. doi: 10.1016/j.urology.2014.02.062. Epub 2014 Jun 25.
To successfully perform male sling surgery, and the surgery must achieve proximal urethral relocation and/or bulbar urethral compression. The Virtue quadratic sling is a novel device that incorporates both mechanisms of action. We report the 1-year results of the Virtue sling with fixation and compare it with the results of the initial "unfixed" sling trial.
A prospective trial was performed to assess the efficacy and safety of the Virtue sling. Objective success was predefined as >50% decrease in 24-hour pad weight and subjective success as a score of "much" or "very much" better on the Patient Global Impression of Improvement. Subgroups were analyzed by baseline incontinence: mild (<100 g), moderate (100-400 g), and severe (>400 g). After analysis of the 1-year data, a second clinical trial incorporating a novel "fixation" technique was performed, with similar outcome measures.
In the initial cohort, subjective and objective successes were achieved in 41.9% at 12 months. Median pad weight reduction was 51.1% at 12 months and varied with the degree of baseline leakage. In the fixation cohort, subjective and objective successes were 70.9% and 79.2%, median pad weight reduction was 88.3% at 12 months, and efficacy was similar regardless of baseline incontinence. There were no cases of prolonged retention and no severe adverse events.
The Virtue sling with fixation is a safe and efficacious treatment for postprostatectomy incontinence. Superior 12-month results compared with the unfixed device demonstrate that fixation prevents early sling loosening.
成功进行男性吊带手术，手术必须实现近端尿道移位和/或球部尿道压迫。Virtue 四叉吊带是一种新型装置，结合了两种作用机制。我们报告了 Virtue 吊带固定的 1 年结果，并将其与初始“未固定”吊带试验的结果进行比较。
进行了一项前瞻性试验，以评估 Virtue 吊带的疗效和安全性。客观成功定义为 24 小时尿垫重量减少>50%，主观成功定义为患者总体改善评分“明显”或“非常明显”更好。根据基线失禁情况（轻度<100g、中度 100-400g、重度>400g）进行亚组分析。在分析 1 年数据后，进行了第二项临床试验，纳入了一种新的“固定”技术，具有相似的结果测量。
在初始队列中，12 个月时主观和客观成功率分别为 41.9%。12 个月时尿垫重量减少中位数为 51.1%，且与基线漏尿程度相关。在固定队列中，主观和客观成功率分别为 70.9%和 79.2%，12 个月时尿垫重量减少中位数为 88.3%，并且无论基线失禁程度如何，疗效都相似。没有出现长期留置和严重不良事件。
固定 Virtue 吊带是治疗前列腺切除术后尿失禁的一种安全有效的方法。与未固定装置相比，12 个月时的优异结果表明，固定可防止早期吊带松动。
