Periurethral injection therapy for urinary incontinence in women

 

Abstract

Background

Periurethral or transurethral injection of bulking agents is a surgical procedure most often used for the treatment of stress urinary incontinence a common, troublesome symptom amongst adult women.

Objectives

To assess the effects of periurethral/transurethral injection therapy in the treatment of urinary incontinence in women.

Search methods

We searched the Cochrane Incontinence Group Specialised Trials Register (28 February 2007), MEDLINE (January 1996 to March 2007, PREMEDLINE (7 February 2007) and the reference lists of relevant articles.

Selection criteria

All randomised or quasi-randomised controlled trials of treatment for urinary incontinence, in which at least one management arm involved periurethral/transurethral injection therapy.

Data collection and analysis

Two reviewers independently assessed methodological quality of each study using explicit criteria. Data extraction was undertaken independently using a standard form and clarification concerning possible unreported data sought directly from the investigators.

Main results

We identified twelve trials including 1318 women that met the inclusion criteria. The limited data available were not suitable for meta-analysis. Injection of autologous fat was compared to placebo in a study of 68 women which was terminated early because of safety concerns. No differences in subjective or objective outcome were found in the two groups. No studies were found comparing injection therapy with conservative treatment. Two studies that compared injection with surgical management found significantly better objective outcome in the surgical group. Eight studies compared different agents - all results had wide confidence intervals. Silicone particles, calcium hydroxylapatite, ethylene vinyl alcohol and carbon spheres gave improvements equivalent to collagen. Porcine dermal implant gave improvements comparable to silicone at six months. A comparison of periurethral and transurethral methods of delivery of the bulking agent found similar outcome but a higher rate of early complications in the periurethral group.

Authors' conclusions

Despite five additional trials, this updated review is still an unsatisfactory basis for practice. The trials were small and generally of moderate quality. The only evidence of benefit comes for within-group short-term changes following injection. The finding that placebo saline injection was followed by a similar symptomatic improvement questions the mechanism of any effects. There were no trials in comparison with pelvic floor muscle training -the obvious non-surgical comparator. Greater symptomatic improvement was observed after surgery, although these advantages need to be set against likely higher risks. No clear-cut conclusions could be drawn from trials comparing alternative agents; one small trial suggests that periurethral injection may carry more risks than transurethral injection. The single trial of autologous fat provides a reminder that periurethral injections can occasionally cause serious side-effects. Pending further evidence, injection therapy may represent a useful option for short-term symptomatic relief amongst selected women with co-morbidity that precludes anaesthesia - two or three injections are likely to be required to achieve a satisfactory result.

 

Plain language summary

Injections of bulking agents for urinary incontinence in women

Stress incontinence is losing urine when coughing, laughing, sneezing or exercising. Usually, muscles and tissue form a cushion supporting the pressure balance around the bladder. If they do not, artificial cushioning can be created by injecting bulking agents into the area around the urethra (passage through which urine leaves the body). The review of twelve trials including 1318 women found some but only limited evidence that this can relieve stress incontinence in women. Other methods might be preferable. Using the women's own fat tissues as the agent injected can cause serious complications.

 

摘要

背景

尿道周圍注射療法應用於婦女尿失禁

尿道周圍或經尿道注射療法是成年女性一項常見且困擾症狀應力性尿失禁最常用的外科療法。

目標

評估尿道周圍／經尿道注射療法對婦女尿失禁的療效

搜尋策略

我們搜尋Cochrane Incontinence Group Specialised Trials Register (2007年2月28日)，MEDLINE(1996年1月到2007年3月)PREMEDLINE(2007年2月)參考文獻表中相關的文章

選擇標準

所有至少評估做過尿道周圍或經尿道注射療法一次之尿失禁成人的隨機對照試驗或半隨機試驗

資料收集與分析

由兩位審查者分別使用明確的準則評估各研究方法之品質。分別由這些試驗中以標準化方式摘錄資料，並說明可能直接由研究者搜尋而來但未經報告的資料

主要結論

我們找到12篇試驗，總共包含1318位符合條件的女性。這些獲得的受限制資料不適用於metanalysis。其中一項針對68位女性比較自體脂肪注射與安慰劑的研究(因考量安全因素而提前終止)，兩族群間沒有任何主觀或客觀上差異的結果。沒有關於合併使用注射治療和保守療法的研究。有兩篇研究是比較注射治療與手術治療間的差異，發現手術治療組的結果顯著較佳。. 有八篇研究分別比較各種不同的注射藥劑，所有結果均有較寬的信賴區間。Silicone particles, calcium hydroxylapatite, ethylene vinyl alcohol, carbon spheres和collagen的治療效果相近，六個月時Porcine dermal implant和silicone比起來有更好的療效。有一篇研究比較尿道周圍和經尿道注射二種方法的療效，兩者的治療效果差異不大，但尿道周圍注射治療早期產生併發症的比率較高。

作者結論

儘管有五項額外的試驗，新的審查結果仍無法作為執行治療的依據，屬於小型且一般性中等品質的試驗。唯一顯示有益的證據為，注射後組內呈現短期的變化。注射安慰劑saline後也被發現有類似的症狀改善，這樣的情形令人對於任何影響機制產生質疑。沒有試驗與非手術型式的骨盆底肌肉訓練方式進行對照。雖然手術治療有較高的風險，但確實有較明顯的症狀改善。比較替代性藥劑的試驗中並無明確的結論；其中一項小型的試驗提出尿道周圍注射相較於經尿道注射的方式有較高的風險；而自體脂肪注射的單一試驗則提醒尿道周圍注射方式可能偶爾會引起嚴重的副作用。在更新一步的實證出來前，對於因合併症無法進行麻醉的女性來說，注射療法對於短期症狀的紓解是一項可行的選擇，二或三次的注射也許能達到滿意的結果。

翻譯人

本摘要由中國醫藥大學附設醫院王馨霈翻譯。

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

總結

通常的肌肉和組織會形成緩衝墊，在膀胱周圍維持壓力平衡，若失去功能時，注射至尿道(尿液離開身體的通道)周圍的藥劑則會形成人工的緩衝功能。審查的十二篇試驗合計納入1318位女性，發現一些但有限的實證顯示能夠緩解婦女壓迫性尿失禁的情形；其他的方法可能是適合的，而使用女性自體脂肪組織作為注射藥劑的方式則會導致嚴重併發症產生。