Thubert Thibault, Canel Virginie, Vinchant Marie, Wigniolle Ingrid, Fernandez Hervé, Deffieux Xavier
APHP, Hôpitaux Universitaires Paris Sud, Hôpital Antoine Béclère, Service de Gynécologie Obstétrique et Médecine de la Reproduction, Clamart F-94000, France.
APHP, Hôpitaux Universitaires Paris Sud, Hôpital Bicêtre, Service de Gynécologie Obstétrique, Le Kremlin Bicetre F-94275, France.
Eur J Obstet Gynecol Reprod Biol. 2016 Mar;198:78-83. doi: 10.1016/j.ejogrb.2016.01.012. Epub 2016 Jan 11.
Although placement of a retropubic mid-urethral slings (MUS) is one of the gold standard surgical treatments for stress urinary incontinence, new devices are poorly evaluated before marketing. We compared TVT-EXACT™ (TVT-E), a new device expected to reduce bladder injuries, with the historically described bottom-to-top TVT™ (TVT).
This retrospective study compared TVT-E (n=49) and TVT (n=49). The main outcomes were the prevalence of complications (bladder injuries, immediate postoperative pain, perioperative complications, etc.) and the short-term success rate (no reported urinary leakage and negative cough test) of both MUSs.
Minimum follow-up was 12 months. The characteristics of the two groups were comparable. The prevalence of bladder injury for TVT-E and TVT was 8% and 6%, respectively (p=1). The intensity of immediate postoperative pain (VAS/100) was lower following TVT-E than after TVT (8.0 vs. 15.9, p=0.01). The first post-void residual was increased in the TVT-E group (153.9 vs. 78.9mL, p=0.045), and there were more postoperative bladder outlet obstruction (BOO) symptoms in the TVT-E group (24% vs. 6%, p=0.02). However, there was no difference when considering only de novo BOO (14% vs. 4%, p=0.16). The prevalence of peri- and post-operative complications was equal in the two groups. The success rate was similar at 12 months of follow-up (80 vs. 82%, p=1).
The prevalence of bladder injury was unchanged with TVT-EXACT™ compared with TVT™, but post-operative pain was decreased. The success rate of both retropubic MUSs was similar at 12 months of follow-up.
尽管耻骨后尿道中段吊带术（MUS）是压力性尿失禁的金标准手术治疗方法之一，但新设备在上市前评估不足。我们将有望减少膀胱损伤的新设备TVT-EXACT™（TVT-E）与历史描述的自下而上的TVT™（TVT）进行了比较。
这项回顾性研究比较了TVT-E（n = 49）和TVT（n = 49）。主要结局是两种MUS的并发症发生率（膀胱损伤、术后即刻疼痛、围手术期并发症等）和短期成功率（无尿漏报告且咳嗽试验阴性）。
最小随访时间为12个月。两组特征具有可比性。TVT-E和TVT的膀胱损伤发生率分别为8%和6%（p = 1）。TVT-E术后即刻疼痛强度（VAS/100）低于TVT（8.0对15.9，p = 0.01）。TVT-E组首次排尿后残余尿量增加（153.9对78.9mL，p = 0.045），且TVT-E组术后膀胱出口梗阻（BOO）症状更多（24%对6%，p = 0.02）。然而，仅考虑新发BOO时无差异（14%对4%，p = 0.16）。两组围手术期和术后并发症发生率相等。随访12个月时成功率相似（80%对82%，p = 1）。
与TVT™相比，TVT-EXACT™的膀胱损伤发生率未变，但术后疼痛减轻。两种耻骨后MUS在随访12个月时成功率相似。
