Lim Jeanette L, de Cuyper Eva M J, Cornish Ann, Frazer Malcolm
Department of Urogynaecology, Royal Women's Hospital, corner Grattan Street and Flemington Road, Parkville, Vic. 3052, Australia.
Aust N Z J Obstet Gynaecol. 2010 Apr;50(2):168-72. doi: 10.1111/j.1479-828X.2010.01139.x.
The TVT-Secur (Ethicon, Somerville, NJ, USA) is a minimally invasive suburethral synthetic sling used in the treatment of female stress urinary incontinence. It claims to cause less postoperative pain and to enable performing in an office setting. However, this may be at the expense of a significant learning curve and a higher early failure rate.
To assess objectively the success rate of the TVT-Secur procedure in the 'U' configuration at six months. Secondary outcomes focussed on subjective success rates, complications, patient satisfaction and quality-of-life (QOL).
A prospective observational study was undertaken at two tertiary referral urogynaecology centres. A cohort of 42 consecutive patients with urodynamic stress incontinence who underwent the TVT-Secur procedure in the 'U' configuration between November 2006 and August 2007 were followed up for six months. Three standardised QOL questionnaires were completed preoperatively and at six months. A urogenital history, visual analogue score (VAS) for patient satisfaction, uroflow and urinary stress test were performed at six months.
Recruitment was ceased prematurely because of a high number of early failures. Objective and subjective success rates at six months were 58.3% and 51.3% respectively. Complications included urinary tract infections, voiding difficulty, groin discomfort, haematoma, vaginal pain, tape erosion and intra-operative dislodgement of tape. Prevalence of de novo urge incontinence was 10.3%. Only symptom-specific QOL scores improved and only 48.6% indicated a high level satisfaction (VAS > or = 80%) with TVT-Secur.
On the basis of this limited study, we are hesitant to recommend the 'U' configuration of the TVT-Secur over its more established counterparts, the TVT and TVT-O.
TVT-Secur（美国新泽西州萨默维尔市爱惜康公司生产）是一种用于治疗女性压力性尿失禁的微创尿道下合成吊带。它宣称术后疼痛较轻，且可在门诊环境中进行手术。然而，这可能是以显著的学习曲线和较高的早期失败率为代价的。
客观评估TVT-Secur手术“U”形配置在六个月时的成功率。次要结果集中在主观成功率、并发症、患者满意度和生活质量（QOL）。
在两个三级转诊泌尿妇科中心进行了一项前瞻性观察研究。对2006年11月至2007年8月期间连续42例接受TVT-Secur手术“U”形配置的尿动力学压力性尿失禁患者进行了为期六个月的随访。术前和六个月时完成了三份标准化的QOL问卷。六个月时进行了泌尿生殖系统病史、患者满意度视觉模拟评分（VAS）、尿流率和尿失禁压力测试。
由于早期失败病例数量较多，招募提前终止。六个月时的客观和主观成功率分别为58.3%和51.3%。并发症包括尿路感染、排尿困难、腹股沟不适、血肿、阴道疼痛、吊带侵蚀和术中吊带移位。新发急迫性尿失禁的发生率为10.3%。只有特定症状的QOL评分有所改善，只有48.6%的患者对TVT-Secur表示高度满意（VAS≥80%）。
基于这项有限的研究，我们对推荐TVT-Secur的“U”形配置优于其更成熟的同类产品TVT和TVT-O持谨慎态度。
