Cody J, Wyness L, Wallace S, Glazener C, Kilonzo M, Stearns S, McCormack K, Vale L, Grant A
Health Services Research Unit, Institute of Applied Health Sciences, University of Aberdeen, UK.
Health Technol Assess. 2003;7(21):iii, 1-189. doi: 10.3310/hta7210.
To evaluate the effectiveness and cost-effectiveness of tension-free vaginal tape (TVT) in comparison with the standard surgical interventions currently used.
Literature searches were carried out on electronic databases and websites for data covering the period 1966--2002. Other sources included references lists of relevant articles; selected experts in the field; abstracts of a limited number of conference proceedings titles; and the Internet.
A systematic review of studies including comparisons of TVT with any of the comparators was conducted. Alternative treatments considered were abdominal retropubic colposuspension (including both open and laparoscopic colposuspension), traditional suburethral sling procedures and injectable agents (periurethral bulking agents). The identified studies were critically appraised and their results summarised. A Markov model comparing TVT with the comparators was developed using the results of the review of effectiveness and data on resource use and costs from previously conducted studies. The Markov model was used to estimate costs and quality-adjusted life-years for up to 10 years following surgery and it incorporated a probabilistic analysis and also sensitivity analysis around key assumptions of the model.
Based on limited data from direct comparisons with TVT and from systematic reviews, laparoscopic colposuspension and traditional slings have broadly similar cure rates to TVT and open colposuspension, whereas injectable agents appear to have lower cure rates. TVT is less invasive than colposuspension and traditional sling procedures, and is also usually performed under regional or local anaesthesia. The principal operative complication is bladder perforation. There are currently no randomised controlled trial (RCT) data beyond 2 years post-surgery, and long-term effects are therefore currently not known reliably. TVT was more likely to be considered cost-effective compared with the other surgical procedures. Increasing the absolute probability of cure following TVT reduced the likelihood that TVT would be considered cost-effective.
The long-term performance of TVT in terms of both continence and unanticipated adverse effects is not known reliably at the moment. Despite relatively few robust comparative data, it appears that in the short to medium term TVT's effectiveness approaches that of alternative procedures currently available, and is of lower cost. As TVT is a less invasive procedure, it is possible that some women who would currently be managed non-surgically will be considered eligible for TVT. Increased adoption of TVT will require additional surgeons proficient in the technique. It is likely that some of the higher rates of complications, e.g. bladder perforation, reported for TVT are associated with a 'learning curve'. Appropriate training will therefore be needed for surgeons new to the operation, in respect of both the technical aspects of the procedure and the choice of women suitable for the operation. Further research suggestions include unbiased assessments of longer term performance from follow-up of controlled trials or population-based registries; more data from methodologically sound RCTs using standard outcome measures; a surveillance system to detect longer term complications, if any, associated with the use of tape; and rigorous evaluation before extending the use of TVT to women who are currently managed non-surgically.
评估无张力阴道吊带术（TVT）与目前使用的标准外科手术干预措施相比的有效性和成本效益。
在电子数据库和网站上进行文献检索，以获取1966年至2002年期间的数据。其他来源包括相关文章的参考文献列表；该领域的选定专家；有限数量会议论文标题的摘要；以及互联网。
对包括TVT与任何对照措施比较的研究进行系统综述。考虑的替代治疗方法有耻骨后阴道膀胱颈悬吊术（包括开放和腹腔镜膀胱颈悬吊术）、传统尿道下吊带手术和注射剂（尿道周围填充剂）。对识别出的研究进行严格评估并总结其结果。利用有效性综述结果以及先前研究的资源使用和成本数据，建立了一个比较TVT与对照措施的马尔可夫模型。该马尔可夫模型用于估计手术后长达10年的成本和质量调整生命年，并纳入了概率分析以及围绕模型关键假设的敏感性分析。
基于与TVT直接比较的有限数据以及系统综述，腹腔镜膀胱颈悬吊术和传统吊带术的治愈率与TVT和开放膀胱颈悬吊术大致相似，而注射剂的治愈率似乎较低。TVT的侵入性低于膀胱颈悬吊术和传统吊带手术，并且通常在区域或局部麻醉下进行。主要手术并发症是膀胱穿孔。目前尚无术后2年以上的随机对照试验（RCT）数据，因此目前无法可靠地了解长期效果。与其他外科手术相比，TVT更有可能被认为具有成本效益。提高TVT术后治愈的绝对概率会降低TVT被认为具有成本效益的可能性。
目前尚无法可靠地了解TVT在尿失禁和意外不良反应方面的长期表现。尽管可靠的比较数据相对较少，但在短期至中期，TVT的有效性似乎接近目前可用的替代手术，且成本较低。由于TVT是一种侵入性较小的手术，一些目前接受非手术治疗的女性可能会被认为适合TVT。TVT的更多采用将需要更多精通该技术的外科医生。TVT报告的一些较高并发症发生率，例如膀胱穿孔，可能与“学习曲线”有关。因此，对于新开展该手术的外科医生，在手术技术方面以及适合手术的女性选择方面都需要进行适当培训。进一步的研究建议包括对对照试验或基于人群的登记随访的长期表现进行无偏评估；使用标准结局指标从方法学合理的RCT中获取更多数据；建立一个监测系统以检测与使用吊带相关的任何长期并发症；以及在将TVT的使用扩展到目前接受非手术治疗的女性之前进行严格评估。
