Ross Sue, Tang Selphee, Schulz Jane, Murphy Magnus, Goncalves Jose, Kaye Stephen, Dederer Lorel, Robert Magali
Department of Obstetrics and Gynecology, University of Calgary, Calgary, Alberta, Canada.
BMC Res Notes. 2014 Dec 22;7:941. doi: 10.1186/1756-0500-7-941.
In 2006, Ethicon Inc. introduced a new minimally invasive single incision sling device for the surgical treatment of stress urinary incontinence, the Gynecare TVT Secur®. For device licensing, no new evidence of TVT Secur efficacy and safety was needed: rather evidence was provided of the long-term follow-up of patients who had a procedure using a predecate retropubic tension-free vaginal tape device. Before adopting TVT Secur into our routine clinical practice, we decided to evaluate it. The objective of our Canadian multi-centre pragmatic randomized controlled trial was to compare the effectiveness of the new single-incision device, TVT Secur, to the established TVT device, in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively. Other outcomes included: complications, symptoms, and incontinence-related quality of life.
The sample size estimate for our trial was 300, but the trial stopped early because of poor recruitment. 74 women participated (40 allocated to TVT Secur, 34 to TVT). At 12 months postoperatively, 27/33(82%) of TVT Secur group were cured, compared with 25/28(89%) of the TVT group (relative risk 0.92, 95% confidence interval 0.75 to 1.13, p=0.49). Most women reported little or no SUI symptoms (35/37(95%) vs 29/30(97%), >0.999). Quality of life improved significantly from baseline for both groups (IIQ-7 mean change -25 for both groups) but did not differ between groups (p=0.880).
Our small randomized trial did not find statistically significant differences in outcomes between women allocated to the TVT Secur device versus those allocated to the TVT device for stress urinary incontinence. Despite the discontinuation of TVT Secur in March 2013 for commercial reasons, the importance of our study lies in making evidence available for the many women who had a TVT Secur device implanted and their physicians who may be considering alternative treatments. Our experience illustrates the difficulty of undertaking research on new licensed devices in a rapidly changing surgical specialty, and further highlights the need for research before licensing if surgeons and their patients are to be confident in the effectiveness and safety of new surgical devices.
ClinicalTrials.gov NCT00685217, 22 May 2008.
2006年，爱惜康公司推出了一种用于手术治疗压力性尿失禁的新型微创单切口吊带装置，即吉妮环TVT Secur®。对于该装置的许可，无需提供TVT Secur有效性和安全性的新证据：而是提供了使用前代耻骨后无张力阴道吊带装置进行手术的患者的长期随访证据。在将TVT Secur应用于我们的常规临床实践之前，我们决定对其进行评估。我们这项加拿大多中心实用随机对照试验的目的是，比较新型单切口装置TVT Secur与已确立的TVT装置在术后12个月时压力性尿失禁（SUI）客观治愈率方面的有效性。其他结果包括：并发症、症状以及与尿失禁相关的生活质量。
我们试验的样本量估计为300例，但由于招募情况不佳，试验提前终止。74名女性参与了试验（40名被分配至TVT Secur组，34名被分配至TVT组）。术后12个月时，TVT Secur组33例中有27例（82%）治愈，而TVT组28例中有25例（89%）治愈（相对风险0.92，95%置信区间0.75至1.13，p = 0.49）。大多数女性报告很少或没有SUI症状（37例中的35例（95%）对30例中的29例（97%），p>0.999）。两组的生活质量均较基线有显著改善（两组IIQ - 7平均变化均为 - 25），但组间无差异（p = 0.880）。
我们这项小型随机试验未发现分配至TVT Secur装置的女性与分配至TVT装置的女性在压力性尿失禁结局方面存在统计学显著差异。尽管TVT Secur因商业原因于2013年3月停产，但我们研究的重要性在于为许多植入了TVT Secur装置的女性及其可能正在考虑替代治疗的医生提供了证据。我们的经验说明了在快速变化的外科专业中对新许可装置进行研究的困难，并进一步强调了在许可前进行研究的必要性，以便外科医生及其患者能够对新手术装置的有效性和安全性充满信心。
ClinicalTrials.gov NCT00685217，2008年5月22日。
