Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women

 

Abstract

Background

Stress urinary incontinence (SUI) is a common condition affecting up to 30% of women. Minimally invasive synthetic suburethral sling operations are among the latest forms of procedures introduced to treat SUI.

Objectives

To assess the effects of minimally invasive synthetic suburethral sling operations for treatment of SUI, urodynamic stress incontinence (USI) or mixed urinary incontinence (MUI) in women.

Search methods

We searched the Cochrane Incontinence Group Specialised Register (searched 20 March 2008), MEDLINE (January 1950 to April 2008), EMBASE (January 1988 to April 2008), CINAHL (January 1982 to April 2008), AMED (January 1985 to April 2008), the UK National Research Register, ClinicalTrials.gov, and reference lists of relevant articles.

Selection criteria

Randomised or quasi-randomised controlled trials amongst women with SUI, USI or symptoms of stress or mixed urinary incontinence, in which at least one trial arm involved a minimally invasive synthetic suburethral sling operations.

Data collection and analysis

Two review authors assessed the methodological quality of potentially eligible studies and independently extracted data from the included trials.

Main results

Sixty two trials involving 7101 women were included. The quality of evidence was moderate for most trials. Minimally invasive synthetic suburethral sling operations appeared to be as effective as traditional suburethral slings ( trials, n = 599, Risk Ratio (RR) 1.03, 95% Confidence Interval (CI) 0.94 to 1.13) but with shorter operating time and less post-operative voiding dysfunction and de novo urgency symptoms.

Minimally invasive synthetic suburethral sling operations appeared to be as effective as open retropubic colposuspension (subjective cure rate at 12 months RR 0.96, 95% CI 0.90 to 1.03; at 5 years RR 0.91, 95% CI 0.74 to 1.12) with fewer perioperative complications, less postoperative voiding dysfunction, shorter operative time and hospital stay but significantly more bladder perforations (6% versus 1%, RR 4.24, 95% CI 1.71 to 10.52).

There was conflicting evidence about the effectiveness of minimally invasive synthetic suburethral sling operations compared to laparoscopic colposuspension in the short term (objective cure, RR 1.15, 95% CI 1.06 to 1.24; subjective cure RR 1.11, 95% CI 0.99 to 1.24). Minimally invasive synthetic suburethral sling operations had significantly less de novo urgency and urgency incontinence, shorter operating time, hospital stay and time to return to daily activities.

A retropubic bottom-to-top route was more effective than top-to-bottom route (RR 1.10, 95% CI 1.01 to 1.20; RR 1.06, 95% CI 1.01 to 1.11) and incurred significantly less voiding dysfunction, bladder perforations and tape erosions.

Monofilament tapes had significantly higher objective cure rates (RR 1.15, 95% CI 1.02 to 1.30) compared to multifilament tapes and fewer tape erosions (1.3% versus 6% RR 0.25, 95% CI 0.06 to 1.00).

The obturator route was less favourable than the retropubic route in objective cure (84% versus 88%; RR 0.96, 95% CI 0.93 to 0.99; 17 trials, n = 2434), although there was no difference in subjective cure rates. However, there was less voiding dysfunction, blood loss, bladder perforation (0.3% versus 5.5%, RR 0.14, 95% CI 0.07 to 0.26) and shorter operating time with the obturator route.

Authors' conclusions

The current evidence base suggests that minimally invasive synthetic suburethral sling operations are as effective as traditional suburethral slings, open retropubic colposuspension and laparoscopic colposuspension in the short term but with less postoperative complications. Objective cure rates are higher with retropubic tapes than with obturator tapes but retropubic tapes attract more complications. Most of the trials had short term follow up and the quality of the evidence was variable.

 

Plain language summary

Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women.  

Stress urinary incontinence (involuntary leakage of urine on effort, or exertion, or on sneezing or coughing or laughing) is the commonest form of incontinence in women and reduces their quality of life. One in three women over the age of 18 years will be affected by stress urinary incontinence. Over the years surgery has become less invasive but there are many different types of operations. Minimally invasive synthetic suburethral sling operations are effective and relatively safe with cure rates of about 80% in the short term. They are also suitable for women who have had unsuccessful previous incontinence surgery. There is some evidence to suggest that operations using certain types of tape materials (type 1 meshes) are more effective with fewer complications (such as infections and tape erosions into the vagina or urethra) than other types. There are two ways of carrying out these operations, either behind the pubic bone or through the groin. Those passing behind the pubic bone are more effective and longer follow-up results are available, but they result in more problems with passing urine after operation and more cases of bladder injury. A major limitation is that long term follow-up data for the effectiveness of many of these procedures are lacking.

 

摘要

背景

針對應力性尿失禁的婦女之微創性尿道下吊索手術

應力性尿失禁(SUI)是一種常見的疾病，高達 30％的女性受其影響。微創性尿道下吊索手術是治療應力性尿失禁最新的方式。

目標

評估微創性尿道下吊索手術在治療應力性尿失禁(SUI)，尿動力學壓力性尿失禁(USI)或混合性尿失禁(MUI)的婦女。

搜尋策略

我們檢索了考科藍實證醫學資料庫尿失禁專科試驗(搜查日期08年3月20日)，MEDLINE(1950年1月至2008年4月)，EMBASE(1988年1月至2008年4月)，CINAHL(1982年1月至2008年4月)，AMED(1985年1月至2008年4月)，英國國家研究資料庫，ClinicalTrials.gov，以及相關的參考文獻。

選擇標準

隨機或半隨機對照試驗研究關於婦女具有SUI, USI或MUI症狀者，其中至少有一試驗項目為微創性尿道下吊索手術 。

資料收集與分析

兩個審閱作者評估符合標準試驗之方法學優劣並單獨由試驗中提取數據。

主要結論

一共62個試驗，包含7101名婦女被納入評估。大部分的試驗具有中等的品質。微創性尿道下吊索手術似乎與傳統尿道下吊索手術有一樣的效果(試驗，n = 599，相對危險性：1.03，95％信賴區間(CI)0.94至1.13)，但手術時間較短，較低比例的手術後排尿功能障礙和原發性尿急症候群。微創性尿道下吊索手術似乎與開腹式恥骨後陰道懸吊術同樣有效(12個月主觀治癒率 相對危險性：0.96，95％CI為 0.90至1.03;五年,相對危險性：0.91，95％CI為 0.74 至1.12)但有較低的手術時期併發症，術後排尿功能障礙，而且手術時間與住院時間短，但有顯著的膀胱穿孔(6％和1％，相對危險性4.24，95％CI為 1.71至10.52)。但在比較微創性尿道下吊索手術與腹腔鏡陰道懸吊術之短期效果出現矛盾的結果(客觀治癒率，相對危險性：1.15，95％CI為1.06至1.24; 主觀治癒率, 相對危險性：1.11，95％CI為 0.99至1.24)。微創性尿道下吊索手術已明顯減少原發性尿急和尿失禁，縮短手術時間，住院時間和恢復日常生活的時間。恥骨後自下而上路徑比從自上而下的路徑有效(相對危險性：1.10，95％CI為1.01至1.20，相對危險性：1.06，95％CI為1.01至1.11)和顯著減低手術造成的排尿障礙，膀胱穿孔和吊帶腐蝕。與複合纖維絲吊帶相比，單纖維絲吊帶顯著提高客觀治癒率(相對危險性： 1.15，95％CI為1.02至1.30)和減少吊帶腐蝕(1.3％和6％，相對危險性：0.25，95％CI為 0.06至1.00)。閉孔路線在客觀治癒率上低於恥骨後路線(84％比88％，相對危險性：0.96，95 ％CI為 0.93～0.99; 17個試驗，n = 2434)，雖然沒有主觀治癒率上的差別。但是，閉孔路線具有較低的排尿功能障礙，失血，膀胱穿孔(0.3％和5.5％，相對危險性：0.14，95％CI為 0.07～0.26)和較短的手術時間。

作者結論

現有的證據顯示，與傳統尿道下吊索手術，開放恥骨陰道懸吊術及腹腔鏡陰道懸吊術在短期內相比，微創性尿道下吊索手術同樣有效，但後者術後併發症少。女性較不易在經由閉孔路徑(不是恥骨)之手術後控制排尿，但其併發症少。大多數試驗都有進行短期追蹤而結果是多變的。

翻譯人

本摘要由中國醫藥大學附設醫院陳祖裕翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

應力性尿失禁(在用力、勞累，打噴嚏、咳嗽或笑產生的非自願性尿液滲漏)是最常見的婦女尿失禁形式，生活品質會因此而降低。三分之一18歲以上的婦女，受到應力性尿失禁的影響。多年來的發展使手術造成的創傷極小，但手術類型繁多。微創性尿道下吊索手術是有效，相對安全，其短期治癒率約 80％。它也適用於以往尿失禁手術失敗的女性。有一些證據顯示，手術使用某些材質的吊帶(Type I 網狀物)可以比其他材質更有效的減少併發症(如感染和吊帶侵蝕進入陰道或尿道)。有兩種方式進行手術，由背後恥骨或腹股溝。通過恥骨背後的手術方式較為有效而且有較多的長期追蹤資料參考，但他們帶來更多術後排尿的問題及更多膀胱損傷的例子。目前主要限制在對於這些手術流程效益的長期追蹤資料仍舊缺乏。