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女性尿失禁的耻骨后尿道悬吊术。

Suburethral sling operations for urinary incontinence in women.

作者信息

Bezerra C A, Bruschini H

机构信息

Surgery, Divison of Urology, Faculty of Medicine, Foudation ABC, Av. Indico, 30, 6 masculine andar, sala 66, Sao Bernardo do Campo, Sao Paulo, Brazil, 09750903.

出版信息

Cochrane Database Syst Rev. 2001(3):CD001754. doi: 10.1002/14651858.CD001754.

Abstract

BACKGROUND

Suburethral slings are surgical operations used to treat women with urinary incontinence. They were originally designed for recurrent stress incontinence, but have also been used recently for primary cases.

OBJECTIVES

To determine the effects of suburethral slings on stress or mixed urinary incontinence in comparison with other management options.

SEARCH STRATEGY

We searched the Cochrane Incontinence Group's trials register, The UK National Research Register (Issue 1, 2001) and the reference lists of relevant articles. We hand searched the proceedings of the Brazilian Congress of Urology from 1991 to 1999, inclusive. Date of most recent search: March 2001.

SELECTION CRITERIA

Randomised or quasi-randomised trials that included suburethral slings for the treatment of urinary incontinence.

DATA COLLECTION AND ANALYSIS

Both 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, a summary statistic was calculated: a relative risk for dichotomous data and a weighted mean difference for continuous data.

MAIN RESULTS

Seven trials were identified including 682 women - 457 treated with suburethral slings and 225 with other procedures. Four compared suburethral slings with open abdominal retropubic suspensions (Burch/Marshall-Marchetti-Krantz) and one compared suburethral slings with needle suspension (Stamey). In the two last trials, different types of suburethral sling were compared with each other. Six types of slings were included (Teflon, polytetrafluoroethylene, prolene used for tension free vaginal tape (TVT), porcine dermis, lyophilized dura mater and rectus fascia). There were no comparisons of suburethral sling with anterior repair, laparoscopic retropubic suspension, peri-urethral injections, artificial sphincters or conservative management. In respect of short-term cure, overall rates are similar (RR 0.93; 95% CI 0.68 to 1.27) in comparison to open abdominal retropubic suspension. This mainly reflects the results of one larger trial on TVT. However, for long term results, data are too few to give a reliable estimate. Data were too few to address whether other types of suburethral slings were as effective as open abdominal retropubic suspension or needle suspension. There were no detectable differences in terms of voiding dysfunction, urge incontinence or detrusor instability between suburethral slings and abdominal or needle suspensions, but the data were few and the confidence intervals wide. About one in 11 had a complication during TVT, most commonly bladder perforation, but none had serious consequences. In the small trial which compared autologous (rectus fascia) with synthetic (Goretex) slings, 11/32 vs 2/16 women were not cured after a year (RR 0.36, 95% CI 0.09 to 1.45) which is not statistically significant but fewer women with autologous slings had complications (0/32 vs 5/16; RR 21.35, 95% CI 1.25 to 363.78). Two women in the Goretex group had late sling erosion of the urethra requiring removal of the Goretex, although their incontinence remained cured.

REVIEWER'S CONCLUSIONS: Preliminary results from a larger trial provide reassuring evidence about the performance of the less invasive TVT sling procedure. Cure rates after TVT were similar to those following open abdominal retropubic suspension, but with confidence intervals of around 10% absolute difference. About one in 11 women had a complication during TVT, most commonly bladder perforation, but none had serious consequences. Long term results are awaited. The data were too few to address whether other types of suburethral slings were as effective as open abdominal retropubic suspension or needle suspension. There was limited evidence from one small trial that slings made of Goretex had more complications than slings made of rectus fascia. The broader effects of suburethral slings could not be established since trials did not include appropriate outcome measures such as general health status, health economics, pad testing, third party analysis and time to return to normal activity level. Evidence that suburethral slings may be better or worse than other surgical or conservative management is lacking because no trials addressed these comparisons.

摘要

背景

尿道下吊带术是用于治疗女性尿失禁的外科手术。该手术最初设计用于复发性压力性尿失禁,但近来也用于原发性病例。

目的

与其他治疗方法相比,确定尿道下吊带术对压力性或混合性尿失禁的疗效。

检索策略

我们检索了Cochrane尿失禁组试验注册库、英国国家研究注册库(2001年第1期)以及相关文章的参考文献列表。我们手工检索了1991年至1999年(含)巴西泌尿外科学会会议论文集。最近一次检索日期:2001年3月。

入选标准

随机或半随机试验,其中包括使用尿道下吊带术治疗尿失禁。

数据收集与分析

两位评价者独立地从纳入试验中提取数据至标准表格,并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,计算汇总统计量:二分数据的相对危险度和连续数据的加权均数差。

主要结果

共纳入7项试验,包括682名女性——457名接受尿道下吊带术治疗,225名接受其他手术治疗。4项试验比较了尿道下吊带术与开放性耻骨后膀胱颈悬吊术(Burch/Marshall-Marchetti-Krantz术),1项试验比较了尿道下吊带术与针刺悬吊术(Stamey术)。在最后2项试验中,比较了不同类型的尿道下吊带术。共纳入6种吊带(聚四氟乙烯、猪真皮、冻干硬脑膜、腹直肌筋膜、用于无张力阴道吊带术(TVT)的普理灵以及聚四氟乙烯)。未对尿道下吊带术与前壁修补术、腹腔镜耻骨后悬吊术、尿道周围注射、人工括约肌或保守治疗进行比较。就短期治愈率而言,与开放性耻骨后膀胱颈悬吊术相比,总体治愈率相似(相对危险度0.93;95%可信区间0.68至1.27)。这主要反映了一项关于TVT的较大规模试验的结果。然而,就长期结果而言,数据太少,无法给出可靠估计。数据太少,无法确定其他类型的尿道下吊带术是否与开放性耻骨后膀胱颈悬吊术或针刺悬吊术一样有效。尿道下吊带术与耻骨后或针刺悬吊术在排尿功能障碍、急迫性尿失禁或逼尿肌不稳定方面无明显差异,但数据较少,可信区间较宽。约1/11的患者在TVT期间出现并发症,最常见的是膀胱穿孔,但均无严重后果。在比较自体(腹直肌筋膜)吊带与合成(戈尔特斯)吊带的小型试验中,11/32的女性与2/16的女性在1年后未治愈(相对危险度0.36,95%可信区间0.09至1.45),差异无统计学意义,但自体吊带组的并发症较少(0/32比5/16;相对危险度21.35,95%可信区间1.25至363.78)。戈尔特斯组有2名女性出现晚期尿道吊带侵蚀,需要取出戈尔特斯,但她们的尿失禁仍得到治愈。

评价者结论

一项较大规模试验的初步结果为创伤较小的TVT吊带术的效果提供了可靠证据。TVT术后治愈率与开放性耻骨后膀胱颈悬吊术相似,但绝对差异的可信区间约为10%。约1/11的女性在TVT期间出现并发症,最常见的是膀胱穿孔,但均无严重后果。尚待长期结果。数据太少,无法确定其他类型的尿道下吊带术是否与开放性耻骨后膀胱颈悬吊术或针刺悬吊术一样有效。一项小型试验的有限证据表明,戈尔特斯制成的吊带比腹直肌筋膜制成的吊带并发症更多。由于试验未纳入适当的结局指标,如总体健康状况、卫生经济学、护垫试验、第三方分析以及恢复正常活动水平的时间,因此无法确定尿道下吊带术的更广泛影响。缺乏证据表明尿道下吊带术比其他手术或保守治疗更好或更差,因为没有试验涉及这些比较。

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