Rehman Haroon, Bezerra Carlos A, Bruschini Homero, Cody June D, Aluko Patricia
Department of Orthopaedics, Aberdeen Royal Infirmary, NHS Grampian, Foresterhill, Aberdeen, Scotland, UK, AB25 2ZD.
Cochrane Database Syst Rev. 2017 Jul 26;7(7):CD001754. doi: 10.1002/14651858.CD001754.pub4.
Stress urinary incontinence constitutes a significant health and economic burden to society. Traditional suburethral slings are one of the surgical operations used to treat women with symptoms of stress urinary incontinence.
To determine the effects of traditional suburethral slings on stress or mixed incontinence in comparison with other management options.
We searched the Cochrane Incontinence Group Specialised Register (searched 3 June 2010) and the reference lists of relevant articles.
Randomised or quasi-randomised trials that included traditional suburethral slings for the treatment of stress or mixed urinary incontinence.
At least three reviewers independently extracted data from included trials onto a standard form and assessed trial methodological quality. The data abstracted were relevant to predetermined outcome measures. Where appropriate, we calculated a summary statistic: a relative risk for dichotomous data and a weighted mean difference for continuous data.
We included 26 trials involving 2284 women. The quality of evidence was moderate for most trials and there was generally short follow-up ranging from 6 to 24 months.One medium-sized trial compared traditional suburethral sling operations with oxybutynin in the treatment of women with mixed urinary incontinence. Surgery appeared to be more effective than drugs in treating participant-reported incontinence (n = 75, risk ratio (RR) 0.18, 95% confidence interval (CI) 0.08 to 0.43).One trial found that traditional slings were more effective than transurethral injectable treatment (RR for clinician-assessed incontinence within a year 0.21, 95% CI 0.09 to 0.21)Seven trials compared slings with open abdominal retropubic colposuspension. Participant-reported incontinence was lower with the slings after one year (RR 0.75, 95% CI 0.62 to 0.90), but not when assessed by clinicians. Colposuspension, however, was associated with fewer peri-operative complications, shorter duration of use of indwelling catheter and less long-term voiding dysfunction. One study showed there was a 20% lower risk of bladder perforation with the sling procedure but a 50% increase in urinary tract infection with the sling procedure compared with colposuspension. Fewer women developed prolapse after slings (compared with after colposuspension) in two small trials but this did not reach statistical significance.Twelve trials addressed the comparison between traditional sling operations and minimally invasive sling operations. These seemed to be equally effective in the short term (RR for incontinence within first year 0.97, 95% CI 0.78 to 1.20) but minimally invasive slings had a shorter operating time, fewer peri-operative complications (other than bladder perforation) and some evidence of less post-operative voiding dysfunction and detrusor symptoms.Six trials compared one type of traditional sling with another. Materials included porcine dermis, lyophilised dura mater, fascia lata, vaginal wall, autologous dermis and rectus fascia. Participant-reported improvement rates within the first year favoured the traditional autologous material rectus fascia over other biological materials (RR 0.45, 95% CI 0.21 to 0.98). There were more complications with the use of non-absorbable Gore-Tex in one trial.Data for comparison of bladder neck needle suspension with suburethral slings were inconclusive because they came from a single trial with a small specialised population.No trials compared traditional suburethral slings with anterior repair, laparoscopic retropubic colposuspension or artificial sphincters. Most trials did not distinguish between women having surgery for primary or recurrent incontinence when reporting participant characteristics.For most of the comparisons, clinically important differences could not be ruled out.
AUTHORS' CONCLUSIONS: Traditional slings seem to be as effective as minimally invasive slings, but had higher rates of adverse effects. This should be interpreted with some caution however, as the quality of evidence for the studies was variable, follow-up short and populations small, particularly for identifying complication rates. Tradional sling procedures appeared to confer a similar cure rate in comparison to open retropubic colposuspension, but the long-term adverse event profile is still unclear. A brief economic commentary (BEC) identified two studies suggesting that traditional slings may be more cost-effective compared with collagen injection but not cost-effective when compared with minimally invasive sling operations. Reliable evidence to clarify whether or not traditional suburethral slings may be better or worse than other surgical or conservative management options is lacking.
压力性尿失禁给社会带来了重大的健康和经济负担。传统尿道下吊带术是用于治疗有压力性尿失禁症状女性的外科手术之一。
比较传统尿道下吊带术与其他治疗方法对压力性或混合性尿失禁的疗效。
我们检索了Cochrane尿失禁小组专业注册库(检索时间为2010年6月3日)以及相关文章的参考文献列表。
纳入了采用传统尿道下吊带术治疗压力性或混合性尿失禁的随机或半随机试验。
至少三名综述作者独立从纳入试验中提取数据并填入标准表格,同时评估试验方法学质量。提取的数据与预先确定的结局指标相关。在适当情况下,我们计算了汇总统计量:二分数据的相对危险度和连续数据的加权均数差。
我们纳入了26项试验,涉及2284名女性。大多数试验的证据质量为中等,随访时间通常较短,为6至24个月。一项中型试验比较了传统尿道下吊带术与奥昔布宁治疗混合性尿失禁女性的疗效。在治疗参与者报告的尿失禁方面,手术似乎比药物更有效(n = 7例,风险比(RR)0.18,95%置信区间(CI)0.08至0.43)。一项试验发现传统吊带术比经尿道注射治疗更有效(一年内临床医生评估的尿失禁RR为0.21,95% CI 0.09至0.21)。七项试验比较了吊带术与开放式经腹耻骨后膀胱颈悬吊术。一年后,参与者报告的吊带术组尿失禁发生率较低(RR 0.75,95% CI 0.62至0.90),但临床医生评估时并非如此。然而,膀胱颈悬吊术的围手术期并发症较少,留置导尿管使用时间较短,长期排尿功能障碍较少。一项研究表明,与膀胱颈悬吊术相比,吊带术膀胱穿孔风险降低20%,但尿路感染风险增加50%。两项小型试验中,吊带术后发生脱垂的女性较少(与膀胱颈悬吊术后相比),但未达到统计学意义。十二项试验比较了传统吊带术与微创吊带术。短期内两者似乎同样有效(第一年尿失禁RR为0.97,95% CI 0.78至1.20),但微创吊带术手术时间较短,围手术期并发症较少(除膀胱穿孔外),且有一些证据表明术后排尿功能障碍和逼尿肌症状较少。六项试验比较了一种传统吊带术与另一种。材料包括猪真皮、冻干硬脑膜、阔筋膜、阴道壁、自体真皮和腹直肌筋膜。第一年参与者报告的改善率显示,传统自体材料腹直肌筋膜优于其他生物材料(RR 0.45,95% CI 0.21至0.98)。一项试验中使用不可吸收的戈尔特斯材料并发症较多。膀胱颈针刺悬吊术与尿道下吊带术比较的数据尚无定论,因为其来自一项针对特殊小群体的单一试验。没有试验比较传统尿道下吊带术与前路修补术、腹腔镜耻骨后膀胱颈悬吊术或人工括约肌。大多数试验在报告参与者特征时未区分原发性或复发性尿失禁的手术女性。对于大多数比较,无法排除具有临床重要意义的差异。
传统吊带术似乎与微创吊带术效果相同,但不良反应发生率较高。然而,对此应谨慎解读,因为研究的证据质量参差不齐,随访时间短且样本量小,尤其是在确定并发症发生率方面。与开放式耻骨后膀胱颈悬吊术相比,传统吊带术似乎治愈率相似,但长期不良事件情况仍不清楚。一篇简短的经济学评论(BEC)指出,两项研究表明,与胶原蛋白注射相比,传统吊带术可能更具成本效益,但与微创吊带术相比则不具成本效益。缺乏可靠证据来阐明传统尿道下吊带术与其他手术或保守治疗方法相比是更好还是更差。