一项比较 TVT、Pelvicol 和自体筋膜吊带治疗女性压力性尿失禁的随机对照试验。
A randomised controlled trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women.
机构信息
Department of Urogynaecology, Southern General Hospital, Glasgow, UK.
出版信息
BJOG. 2010 Nov;117(12):1493-502. doi: 10.1111/j.1471-0528.2010.02696.x. Epub 2010 Sep 24.
OBJECTIVE
To compare TVT(TM) , Pelvicol(TM) and autologous fascial slings (AFSs).
DESIGN
A multicentre randomised control trial.
SETTING
Four units in the UK.
POPULATION
Women requiring primary surgery for stress urinary incontinence (SUI).
METHODS
A total of 201 women with urodynamically proven stress incontinence were randomised into three groups and assessed at baseline, 6 weeks, 6 months and 1 year.
MAIN OUTCOME MEASURE
The primary outcome was patient-reported improvement rates. Secondary outcomes included operative complications/time, intermittent self-catheterisation (ISC) and re-operation rates. The quality-of-life tools used were the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) and EuroQoL.
RESULTS
Fifty women had a Pelvicol(TM) sling, 79 had AFSs and 72 had TVT(TM). At 6 months the Pelvicol(TM) arm had poorer improvement rates (73%) than TVT(TM) (92%)/AFS (95%); P=0.003. At 1 year only 61% of the Pelvicol(TM) slings remained as improved, versus 93% of TVTs and 90% of AFSs (P<0.001). Pelvicol(TM) has poorer dry rates (22%) than TVT(TM) (55%)/AFS (48%) (P=0.001) at 1 year; hence, the Pelvicol(TM) arm was suspended following interim analysis. There is no difference in the success rates between TVT(TM) and AFS. One in five women in the Pelvicol(TM) arm had further surgery for SUI by 1 year, but none required further surgery in the other arms. AFS took longer to do (54 minutes versus 35 minutes for TVT(TM) /36 minutes for Pelvicol(TM) ) and had higher ISC rates (9.9 versus 0% Pelvicol(TM) /TVT(TM) 1.5%). Hospital stay was shortest for TVT(TM) (2 days). Most BFLUTS domains showed improvement in all three arms. The improvement for women in the Pelvicol(TM) arm, however, was less than for women in the other arms in several key domains.
CONCLUSIONS
Pelvicol(TM) cannot be recommended for the management of SUI. TVT(TM) does not have greater efficacy than AFS, but does utilise fewer resources.
目的
比较 TVT（TM）、Pelvicol（TM）和自体筋膜吊带（AFS）。
设计
多中心随机对照试验。
地点
英国的四个单位。
人群
需要进行原发性压力性尿失禁（SUI）手术的女性。
方法
共纳入 201 名经尿动力学证实患有压力性尿失禁的女性，随机分为三组，在基线、6 周、6 个月和 1 年进行评估。
主要结局指标
主要结局是患者报告的改善率。次要结局包括手术并发症/时间、间歇性自我导尿（ISC）和再次手术率。使用的生活质量工具是布里斯托尔女性下尿路症状（BFLUTS）和 EuroQoL。
结果
50 名女性接受了 Pelvicol（TM）吊带，79 名女性接受了 AFS，72 名女性接受了 TVT（TM）。6 个月时，Pelvicol（TM）组的改善率（73%）低于 TVT（TM）组（92%）/AFS 组（95%）；P=0.003。1 年时，Pelvicol（TM）吊带中只有 61%仍然改善，而 TVT（TM）和 AFS 分别为 93%和 90%（P<0.001）。1 年时，Pelvicol（TM）的干燥率（22%）低于 TVT（TM）（55%）/AFS（48%）（P=0.001）；因此，在中期分析后暂停了 Pelvicol（TM）的使用。TVT（TM）和 AFS 的成功率没有差异。1 年内，Pelvicol（TM）组中有五分之一的女性因 SUI 再次接受手术，但其他两组均无需再次手术。AFS 手术时间更长（54 分钟，而 TVT（TM）为 35 分钟，Pelvicol（TM）为 36 分钟），ISC 发生率更高（9.9%比 Pelvicol（TM）/TVT（TM）为 0%，1.5%）。TVT（TM）的住院时间最短（2 天）。所有三个组的 BFLUTS 域均显示出改善。然而，与其他两组相比，Pelvicol（TM）组女性的改善程度在几个关键领域较低。
结论
不能推荐 Pelvicol（TM）用于治疗 SUI。TVT（TM）的疗效并不优于 AFS，但它利用的资源更少。
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