Nambiar Arjun, Cody June D, Jeffery Stephen T, Aluko Patricia
Department of Urology, Health Education North East/Freeman Hospital, Freeman Road, High Heaton, Newcastle-upon-Tyne, Tyne and Wear, UK, NE7 7DN.
Cochrane Database Syst Rev. 2017 Jul 26;7(7):CD008709. doi: 10.1002/14651858.CD008709.pub3.
Urinary incontinence has been shown to affect up to 50% of women. Studies in the USA have shown that up to 80% of these women have an element of stress urinary incontinence. This imposes significant health and economic burden on society and the women affected. Colposuspension and now mid-urethral slings have been shown to be effective in treating patients with stress incontinence. However, associated adverse events include bladder and bowel injury, groin pain and haematoma formation. This has led to the development of third-generation single-incision slings, also referred to as mini-slings.It should be noted that TVT-Secur (Gynecare, Bridgewater, NJ, USA) is one type of single-incision sling; it has been withdrawn from the market because of poor results. However, it is one of the most widely studied single-incision slings and was used in several of the trials included in this review. Despite its withdrawal from clinical use, it was decided that data pertaining to this sling should be included in the first iteration of this review, so that level 1a data are available in the literature to confirm its lack of efficacy.
To assess the effectiveness of mini-sling procedures in women with urodynamic clinical stress or mixed urinary incontinence in terms of improved continence status, quality of life or adverse events.
We searched: Cochrane Incontinence Specialised Register (includes: CENTRAL, MEDLINE, MEDLINE In-Process) (searched 6 February 2013); ClinicalTrials.gov, WHO ICTRP (searched 20 September 2012); reference lists.
Randomised or quasi-randomised controlled trials in women with urodynamic stress incontinence, symptoms of stress incontinence or stress-predominant mixed urinary incontinence, in which at least one trial arm involves one of the new single-incision slings. The definition of a single-incision sling is "a sling that does not involve either a retropubic or transobturator passage of the tape or trocar and involves only a single vaginal incision (i.e. no exit wounds in the groin or lower abdomen)."
Three review authors assessed the methodological quality of potentially eligible trials and independently extracted data from individual trials.
We identified 31 trials involving 3290 women. Some methodological flaws were observed in some trials; a summary of these is given in the 'Risk of bias in included studies' section.No studies compared single-incision slings versus no treatment, conservative treatment, colposuspension, laparoscopic procedures or traditional sub-urethral slings. No data on the comparison of single-incision slings versus retropubic mid-urethral slings (top-down approach) were available, but the review authors believe this did not affect the overall comparison versus retropubic mid-urethral slings.Types of single-incision slings included in this review: TVT-Secur (Gynecare); MiniArc (American Medical Systems, Minnetonka, USA); Ajust (CR Bard Inc., Covington, USA); Needleless (Mayumana Healthcare, Lisse, The Netherlands); Ophira (Promedon, Cordoba, Argentina); Tissue Fixation System (TFS PTY Ltd, Sydney, Australia) and CureMesh (DMed Co. Inc., Seoul, Korea).Women were more likely to remain incontinent after surgery with single-incision slings than with retropubic slings such as tension-free vaginal tape (TVT) (121/292, 41% vs 72/281, 26%; risk ratio (RR) 2.08, 95% confidence interval (CI) 1.04 to 4.14). Duration of the operation was slightly shorter for single-incision slings but with higher risk of de novo urgency (RR 2.39, 95% CI 1.25 to 4.56). Four of five studies in the comparison included TVT-Secur as the single-incision sling.Single-incision slings resulted in higher incontinence rates compared with inside-out transobturator slings (30% vs 11%; RR 2.55, 95% CI 1.93 to 3.36). The adverse event profile was significantly worse, specifically consisting of higher risks of vaginal mesh exposure (RR 3.75, 95% CI 1.42 to 9.86), bladder/urethral erosion (RR 17.79, 95% CI 1.06 to 298.88) and operative blood loss (mean difference 18.79, 95% CI 3.70 to 33.88). Postoperative pain was less common with single-incision slings (RR 0.29, 95% CI 0.20 to 0.43), and rates of long-term pain or discomfort were marginally lower, but the clinical significance of these differences is questionable. Most of these findings were derived from the trials involving TVT-Secur: Excluding the other trials showed that high risk of incontinence was principally associated with use of this device (RR 2.65, 95% CI 1.98 to 3.54). It has been withdrawn from clinical use.Evidence was insufficient to reveal a difference in incontinence rates with other single-incision slings compared with inside-out or outside-in transobturator slings. Duration of the operation was marginally shorter for single-incision slings compared with transobturator slings, but only by approximately two minutes and with significant heterogeneity in the comparison. Risks of postoperative and long-term groin/thigh pain were slightly lower with single-incision slings, but overall evidence was insufficient to suggest a significant difference in the adverse event profile for single-incision slings compared with transobturator slings. Evidence was also insufficient to permit a meaningful sensitivity analysis of the other single-incision slings compared with transobturator slings, as all confidence intervals were wide. The only significant differences were observed in rates of postoperative and long-term pain, and in duration of the operation, which marginally favoured single-incision slings.Overall results show that TVT-Secur is considerably inferior to retropubic and inside-out transobturator slings, but additional evidence is required to allow any reasonable comparison of other single-incision slings versus transobturator slings.When one single-incision sling was compared with another, evidence was insufficient to suggest a significant difference between any of the slings in any of the comparisons made.
AUTHORS' CONCLUSIONS: TVT-Secur is inferior to standard mid-urethral slings for the treatment of women with stress incontinence and has already been withdrawn from clinical use. Not enough evidence has been found on other single-incision slings compared with retropubic or transobturator slings to allow reliable comparisons. A brief economic commentary (BEC) identified two studies which reported no difference in clinical outcomes between single-incision slings and transobturator mid-urethral slings, but single-incision slings may be more cost-effective than transobturator mid-urethral slings based on one-year follow-up. Additional adequately powered and high-quality trials with longer-term follow-up are required. Trials should clearly describe the fixation mechanism of these single-incisions slings: It is apparent that, although clubbed together as a single group, a significant difference in fixation mechanisms may influence outcomes.
尿失禁影响着高达50%的女性。美国的研究表明，这些女性中高达80%存在压力性尿失禁因素。这给社会和受影响的女性带来了巨大的健康和经济负担。阴道膀胱悬吊术以及现在的中段尿道吊带已被证明对治疗压力性尿失禁患者有效。然而，相关的不良事件包括膀胱和肠道损伤、腹股沟疼痛和血肿形成。这促使了第三代单切口吊带（也称为迷你吊带）的发展。需要注意的是，TVT-Secur（美国新泽西州布里奇沃特的吉尼凯尔公司）是一种单切口吊带；由于效果不佳，它已退出市场。然而，它是研究最广泛的单切口吊带之一，并且被用于本综述纳入的多项试验中。尽管它已停止临床使用，但决定在本综述的第一版中纳入与该吊带相关的数据，以便文献中有1a级数据来证实其缺乏疗效。
评估迷你吊带手术对存在尿动力学临床压力性或混合性尿失禁的女性在改善控尿状态、生活质量或不良事件方面的有效性。
我们检索了：Cochrane尿失禁专科注册库（包括：Cochrane系统评价数据库、医学期刊数据库、医学期刊数据库（正在进行中））（检索时间为2013年2月6日）；ClinicalTrials.gov、世界卫生组织国际临床试验注册平台（检索时间为2012年9月20日）；参考文献列表。
针对存在尿动力学压力性尿失禁、压力性尿失禁症状或以压力性为主的混合性尿失禁的女性进行的随机或半随机对照试验，其中至少一个试验组涉及一种新型单切口吊带。单切口吊带的定义为“一种吊带，其不涉及耻骨后或经闭孔的带或套管通道，仅涉及一个阴道切口（即腹股沟或下腹部无出口伤口）”。
三位综述作者评估了潜在合格试验的方法学质量，并独立从各个试验中提取数据。
我们确定了31项涉及3290名女性的试验。在一些试验中观察到了一些方法学缺陷；这些缺陷的总结在“纳入研究的偏倚风险”部分给出。没有研究比较单切口吊带与不治疗、保守治疗、阴道膀胱悬吊术、腹腔镜手术或传统尿道下吊带。没有关于单切口吊带与耻骨后中段尿道吊带（自上而下法）比较的数据，但综述作者认为这并不影响与耻骨后中段尿道吊带的总体比较。本综述纳入的单切口吊带类型包括：TVT-Secur（吉尼凯尔公司）；MiniArc（美国明尼通卡的美国医疗系统公司）；Ajust（美国科温顿的CR巴德公司）；无针（荷兰利斯的Mayumana医疗保健公司）；Ophira（阿根廷科尔多瓦的Promedon公司）；组织固定系统（澳大利亚悉尼的TFS私人有限公司）和CureMesh（韩国首尔的DMed有限公司）。与耻骨后吊带如无张力阴道吊带（TVT）相比，女性使用单切口吊带手术后仍失禁的可能性更大（121/292，41%对72/281，26%；风险比（RR）2.08，95%置信区间（CI）1.04至4.14）。单切口吊带的手术时间略短，但新发尿急的风险更高（RR 2.39，95% CI 1.25至4.56）。比较中的五项研究中有四项将TVT-Secur作为单切口吊带。与由内向外经闭孔吊带相比，单切口吊带导致的失禁率更高（30%对11%；RR 2.55，95% CI 1.93至3.36）。不良事件情况明显更差，具体表现为阴道网片暴露风险更高（RR 3.75，95% CI 1.42至9.86）、膀胱/尿道侵蚀风险更高（RR 17.79，95% CI 1.06至298.88）以及手术失血量更多（平均差异18.79，95% CI 3.70至33.88）。单切口吊带术后疼痛较少见（RR 0.29，95% CI 0.20至0.43），长期疼痛或不适的发生率略低，但这些差异的临床意义值得怀疑。这些发现大多来自涉及TVT-Secur的试验：排除其他试验表明，高失禁风险主要与该装置的使用有关（RR 2.65，95% CI 1.98至3.54）。它已停止临床使用。与由内向外或由外向内经闭孔吊带相比，证据不足以揭示其他单切口吊带在失禁率方面的差异。与经闭孔吊带相比，单切口吊带的手术时间略短，但仅短约两分钟，且比较中存在显著异质性。单切口吊带术后和长期腹股沟/大腿疼痛的风险略低，但总体证据不足以表明与经闭孔吊带相比，单切口吊带的不良事件情况存在显著差异。与经闭孔吊带相比，对其他单切口吊带进行有意义的敏感性分析的证据也不足，因为所有置信区间都很宽。仅在术后和长期疼痛发生率以及手术时间方面观察到显著差异，单切口吊带在这些方面略占优势。总体结果表明，TVT-Secur明显不如耻骨后和由内向外经闭孔吊带，但需要更多证据才能对其他单切口吊带与经闭孔吊带进行合理比较。当将一种单切口吊带与另一种进行比较时，证据不足以表明在任何比较中任何一种吊带之间存在显著差异。
对于治疗压力性尿失禁的女性，TVT-Secur不如标准的中段尿道吊带，并且已停止临床使用。与耻骨后或经闭孔吊带相比，关于其他单切口吊带的证据不足，无法进行可靠比较。一篇简短的经济评论（BEC）确定了两项研究，这两项研究报告单切口吊带与经闭孔中段尿道吊带在临床结果上没有差异，但基于一年的随访，单切口吊带可能比经闭孔中段尿道吊带更具成本效益。需要进行更多有足够样本量和高质量的长期随访试验。试验应清楚描述这些单切口吊带的固定机制：很明显，尽管归为一组，但固定机制的显著差异可能会影响结果。
