Oestrogen therapy for urinary incontinence in post-menopausal women

 

Abstract

Background

It is possible that oestrogen deficiency may be an aetiological factor in the development of urinary incontinence in women.

Objectives

To assess the effects of local and systemic oestrogens used for the treatment of urinary incontinence.

Search methods

We searched the Cochrane Incontinence Group Specialised Register of trials (2 April 2009) and the reference lists of relevant articles.

Selection criteria

Randomised or quasi-randomised controlled trials that included oestrogens in at least one arm, in women with symptomatic or urodynamic diagnoses of stress, urgency or mixed urinary incontinence or other urinary symptoms post-menopause.

Data collection and analysis

Trials were evaluated for methodological quality and appropriateness for inclusion by the review authors. Data were extracted by at least two authors and cross checked. Subgroup analyses were performed grouping participants under local or systemic administration. Where appropriate, meta-analysis was undertaken.

Main results

Thirty- three trials were identified which included 19,313 (1,262 involved in trials of local administration) incontinent women of whom 9417 received oestrogen therapy. Sample sizes ranged from 16 to 16,117. The trials used varying combinations of type of oestrogen, dose, duration of treatment and length of follow up. Outcome data were not reported consistently and were available for only a minority of outcomes.

Systemic administration (of oral oestrogens) resulted in worse incontinence than on placebo (RR 1.32, 95% CI 1.17 to 1.48). This result is heavily weighted by a subgroup of women from the Hendrix trial, which had large numbers of participants and a longer follow up of one year; all the women had had a hysterectomy and the treatment used was conjugated equine oestrogen. The result for women with an intact uterus where oestrogen and progestogen combined were used also showed a statistically significant worsening of incontinence (RR 1.11, 95% CI 1.04 to 1.18).

There was some evidence that oestrogens used locally (for example vaginal creams or tablets) may improve incontinence (RR 0.74, 95% CI 0.64 to 0.86). Overall, there were around one to two fewer voids in 24 hours and nocturnal voids amongst women treated with local oestrogen, and there was less frequency and urgency. No serious adverse events were reported although some women experienced vaginal spotting, breast tenderness or nausea.

Women who were continent and received systemic oestrogen replacement, with or without progestogens, for reasons other than urinary incontinence were more likely to report the development of new urinary incontinence in one large study.

The data were too few to address questions about oestrogens compared with or in combination with other treatments, different types of oestrogen or different modes of delivery.

Authors' conclusions

Local oestrogen treatment for incontinence may improve or cure it, but there was little evidence from the trials on the period after oestrogen treatment had finished and none about long-term effects. However, systemic hormone replacement therapy, using conjugated equine oestrogen, may make incontinence worse. There were too few data to reliably address other aspects of oestrogen therapy, such as oestrogen type and dose, and no direct evidence on route of administration. The risk of endometrial and breast cancer after long-term use suggests that oestrogen treatment should be for limited periods, especially in those women with an intact uterus.

 

Plain language summary

Oestrogens for urinary incontinence in women

Urinary incontinence is the leakage of urine when coughing or exercising (stress urinary incontinence) or after a strong uncontrollable urge to urinate (urgency urinary incontinence). In women who have gone through the menopause, low oestrogen levels may contribute to urinary incontinence. The review found 33 trials including around 19,000 women of whom around 9000 women received oestrogens. The review found that significantly more women who received local (vaginal) oestrogen for incontinence reported that their symptoms improved compared to placebo. Trials investigating oral administration, on the other hand, found that women who received hormone replacement reported that their urinary symptoms got worse. The evidence comes mainly from two very large trials including 17,642 incontinent women. The trials were investigating other effects of hormone replacement therapy as well as incontinence, such as prevention of heart attacks in women with coronary heart disease, bone fractures, breast and colorectal cancer. In addition, in one large trial, women who did not have incontinence at first were more likely to develop incontinence. There was no evidence about whether benefits continue after stopping treatment but this seems unlikely as women would revert to having naturally low oestrogen levels. There may be risks from long-term use of oestrogen such as heart disease, stroke and cancer of the uterus.

 

摘要

背景

雌激素在婦女尿失禁中扮演的角色

缺乏雌激素可能是導致婦女尿失禁的一個原因。

目標

評估補充雌激素對尿失禁的治療效果。

搜尋策略

我們搜尋考科藍實證醫學資料庫失禁評論小組的臨床試驗註冊者(2002年11月)以及相關的參考文獻. 最近一次搜尋的時間為2002年11月。

選擇標準

搜尋針對經由臨床症狀或經由尿動力學診斷具有應力性尿失禁,或急迫性尿失禁,或混合型尿失禁,或具有其他泌尿道症狀的婦女,以隨機或半隨機對照試驗評估雌激素療效的文章。

資料收集與分析

評論者評估這些試驗的方法學的特性及收集的適合度. 三個評論者負責選錄數據資料,並且互相檢查. 試驗結果以臨床次組或不同的處置方法,以適當的統合方法去作分析。

主要結論

我們一共搜尋到28篇臨床試驗,包含了2926個婦女. 每篇試驗的受試者從16位到1525位不等. 這些試驗的內容包含各式各樣不同的雌激素的種類,劑量,療程長短及後續追蹤的時間長短. 試驗的數據結果只有一小部份可得知而且並沒有持續地被報告出來. 在總共15篇比較使用雌激素以及安慰劑的試驗中,有374位婦女接受雌激素療法,344位婦女使用安慰劑. 結果那些使用雌激素的婦女們,不管她們原本是哪一類型的尿失禁,都獲得主觀上較高的治癒率(36/101,36% v.s. 20/96,21%; 治癒的相對風險:1.61,95%信賴區間:1.04 to 2.49). 當主觀上的治癒及改善狀況一起考慮時,統計學上顯示不管是針對急迫性尿失禁(35/61,57% v.s. 安慰組:16/58, 28%)或應力性尿失禁(46/107, 43% v.s. 安慰組:29/109, 27%),使用雌激素的婦女都具有較高的治癒及改善率. 針對具有急迫性尿失禁的婦女,其治癒及改善的機會更比具應力性尿失禁者高了將近四分之一. 如果比較所有的試驗,數據結果顯示使用雌激素的婦女有大約50%獲得治癒或改善,使用安慰劑者只有25%. 使用雌激素的婦女大致上來說,每24小時都減少了一到二次的排尿次數. 這個效果在急迫性尿失禁的婦女身上又再次地更加明顯. 但針對頻尿,夜尿,尿急迫來說,兩者並無統計學上的差異. 即使有些婦女會有陰道出血,乳房帳痛,嘔吐等表現,目前為止使用雌激素療法並沒有嚴重的副作用. 在一個針對具有心臟病的婦女的試驗中,以電話專訪的數據顯示,尿失禁的婦女同時併用雌激素及黃體素,比起使用安慰劑者有較低的主觀治癒及改善率(治癒的相對風險:0.85, 95% 信賴區間:0.76 to 0.95). 但是由於數據的不足,我們無法比較不同種類,不同投藥方式的雌激素效果,與其他治療方式的差異,或與其他療法合併使用的結果。

作者結論

雌激素能改善或治癒尿失禁,證據顯示針對急迫尿失禁更有效果. 有少量的證據顯示這些臨床試驗已經完成,並沒有提出長期的效果為何. 合併使用雌激素及黃體素會降低治癒及改善的可能性. 由於資料數據的不足,我們無法確實地分析雌激素補充療法的其他層面,像是雌激素的種類,劑量,及給藥方式. 然而,由於考慮到長期使用雌激素療法對於子宮內膜癌及乳癌的風險,我們建議雌激素療法應限制其使用時間,特別是針對那些仍擁有完整子宮的婦女。

翻譯人

本摘要由中國醫藥大學附設醫院江語蓁翻譯。

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

總結

對於患有尿失禁,特別是急迫性尿失禁的婦女們,雌激素可能可以治癒或改善症狀,但合併使用雌激素及黃體素卻可能使情況惡化. 尿失禁是指咳嗽或運動時不自主的漏尿(應力性尿失禁),或因為無法控制的解尿急迫感而漏尿的情形(急迫性尿失禁). 體內太低的雌激素濃度可能導致婦女的尿失禁. 回顧這些臨床試驗,我們發現額外地補充雌激素可能對應力性尿失禁及急迫性尿失禁都有幫助. 但合併使用雌激素及黃體素卻可能使尿失禁更惡化. 並無證據顯示停用雌激素後其治療效果仍能持續. 長期使用雌激素有可能造成一些風險。