Long-term follow-up of a multicentre randomised controlled trial comparing tension-free vaginal tape, xenograft and autologous fascial slings for the treatment of stress urinary incontinence in women
Long-term follow-up of a multicentre randomised controlled trial comparing tension-free vaginal tape, xenograft and autologous fascial slings for the treatment of stress urinary incontinence in women
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DOI：
10.1111/bju.12851
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发表时间：
2015-06-01
影响因子：
4.5
通讯作者：
Lucas, Malcolm G.
中科院分区：
文献类型：
--
作者：
Khan, Zainab A.;Nambiar, Arjun;Lucas, Malcolm G.
目的比较无张力阴道吊带术的远期疗效（TVT; Gynecare，萨默维尔，NJ，美国）、自体筋膜吊带（AFS）和异种移植吊带（猪真皮，Pelvicol;巴德，默里山，新泽西州，压力性尿失禁（SUI）的治疗。患者和方法2001年至2006年，在英国四个中心进行了一项多中心随机对照试验，涉及201名因SUI需要初次手术的女性。这些妇女被随机分配接受TVT，AFS或Pelvicol。主要结局是手术成功，定义为女性报告在随访时完全干燥或改善。次要结果包括完全干燥率，变化的布里斯托女性下尿路症状（BFLUTS）和EuroQoL EQ-5D问卷scores.ResultsIn所有，162（80.6%）妇女可用于随访的中位数（范围）持续时间为10（6.6-12.6）年。TVT、AFS和Pelvicol的成功率分别为73%、75.4%和58%。比较1年和10年的成功率，TVT组从93%恶化到73%（P < 0.05），AFS组从90%恶化到75.4%（P < 0.05）;干燥率分别为31.7%、50.8%和15.7%。总体而言，与Pelvicol（P < 0.001）和TVT（P = 0.036）相比，AFS的干细胞率更高。TVT组持续SUI的再手术率为3.2%（2例），Pelvicol组为13.1%（5例），而AFS组的患者均不需要进一步干预。ConclusionsOur研究表明，没有足够的证据表明AFS和TVT之间的长期成功率存在差异。然而，有一些证据表明，干'率AFS可能比TVT更持久。
ObjectiveTo compare the long-term outcomes of a tension-free vaginal tape (TVT; Gynecare, Somerville, NJ, USA), autologous fascial sling (AFS) and xenograft sling (porcine dermis, Pelvicol; Bard, Murray Hill, NJ, USA) in the management of female stress urinary incontinence (SUI).Patients and MethodsA multicentre randomised controlled trial carried out in four UK centres from 2001 to 2006 involving 201 women requiring primary surgery for SUI. The women were randomly assigned to receive TVT, AFS or Pelvicol. The primary outcome was surgical success defined as women reporting being completely dry' or improved' at the time of follow-up'. The secondary outcomes included completely dry' rates, changes in the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) and EuroQoL EQ-5D questionnaire scores.ResultsIn all, 162 (80.6%) women were available for follow-up with a median (range) duration of 10 (6.6-12.6) years. Success' rates for TVT, AFS and Pelvicol were 73%, 75.4% and 58%, respectively. Comparing the 1- and 10-year success' rates, there was deterioration from 93% to 73% (P < 0.05) in the TVT arm and 90% to 75.4% (P < 0.05) in the AFS arm; dry' rates were 31.7%, 50.8% and 15.7%, respectively. Overall, the dry' rates favoured AFS when compared with Pelvicol (P < 0.001) and TVT (P = 0.036). The re-operation rate for persistent SUI was 3.2% (two patients) in the TVT arm, 13.1% (five) in the Pelvicol arm, while none of the patients in the AFS arm required further intervention.ConclusionsOur study indicates there is not enough evidence to suggest a difference in long-term success rates between AFS and TVT. However, there is some evidence that dry' rates for AFS may be more durable than TVT.