Intervention Review

Intravesical treatments for painful bladder syndrome/ interstitial cystitis

  1. Timothy E Dawson1,*,
  2. Jim Jamison2

Editorial Group: Cochrane Incontinence Group

Published Online: 17 OCT 2007

Assessed as up-to-date: 20 AUG 2007

DOI: 10.1002/14651858.CD006113.pub2

How to Cite

Dawson TE, Jamison J. Intravesical treatments for painful bladder syndrome/ interstitial cystitis. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD006113. DOI: 10.1002/14651858.CD006113.pub2.

Author Information

  1. 1

    Liverpool Women's Hospital, Urogynaecology, Liverpool, Merseyside, UK

  2. 2

    Belfast, Northern Ireland, UK

*Timothy E Dawson, Urogynaecology, Liverpool Women's Hospital, Crown St, Liverpool, Merseyside, L87SS, UK. timothy.dawson@lwh.nhs.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 17 OCT 2007

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC) occurs predominantly in women. It is a poorly-understood condition with symptoms of bladder pain, urinary frequency, urgency and nocturia. Treatments for PBS/IC include dietary/lifestyle interventions, oral medication, intravesical instillations and, in some cases, surgery. Success rates are generally modest and there is little consensus as to the best form of treatment for this condition.

Objectives

To assess the effectiveness of intravesical treatment for PBS/IC.

Search methods

We searched the Cochrane Incontinence Group Specialised Trials Register (30 May 2006) as well as reference lists of all selected trials. Recognised researchers in the field were contacted for any additional relevant material.

Selection criteria

Randomised or quasi-randomised controlled trials were included in the review if they had recruited participants with a clinical diagnosis of PBS/IC and if at least one arm of the trial was treatment with an intravesical preparation. Outcome measures were pre-determined, the primary ones being the effect on pain and bladder capacity. Others included symptomatic response to treatment, quality-of-life assessment, economic factors and adverse events.

Data collection and analysis

Two reviewers independently assessed trial eligibility and quality, then extracted relevant data from the studies.

Main results

Nine eligible trials were identified - six parallel group, one incomplete cross-over and two cross-over trials - with a total of 616 participants. Six trials compared an 'active' instillation with placebo instillation, two compared different types of instillation, and one was a comparison of an instillation plus bladder training versus bladder training alone. Altogether, the review included trials of six different types of intravesical instillation: Resiniferatoxin, Dimethyl sulfoxide, BCG, pentosanpolysulphate, oxybutin, and alkalinisation of urine pH. Confidence intervals were generally wide.

Resiniferatoxin was not associated with sustained differences in the review outcomes reported but pain during instillation and withdrawal from treatment was significantly more common. The data available about Dimethyl sulfoxide (DMSO) were very limited but with no apparent differences from placebo. Groups treated with BCG tended to report less pain and fewer general symptoms. Although adverse events were commonly reported, these were no more common after BCG than after placebo instillation. The few data about Pentosanpolysulphate tended to favour the actively treated, but with wide confidence intervals; there was little information about adverse events. Oxybutinin instillation was associated with increased bladder capacity, reduced frequency, improved quality of life scores and fewer drop-outs. Alkalinisation of urine pH did not make any clear difference, but with potentially wide confidence intervals.

Authors' conclusions

Overall, the evidence base for treating PBS/IC using intravesical preparations is limited and the potential for meta-analysis reduced by variation in the outcome measures used. The quality of trial reports was mixed and in some cases this precluded any meaningful data extraction. BCG and oxybutin are reasonably well-tolerated and evidence is most promising for these. Resiniferatoxin showed no evidence of effect for most outcomes and caused pain, which reduced treatment compliance. There is little evidence for the other treatments included in this review. Randomised controlled trials are still needed and study design should incorporate outcomes that are most relevant to these with PBS/IC and should be standardised.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Intravesical treatments for painful bladder syndrome/interstitial cystitis(PBS/IC).

Interstitial cystitis is also known as painful bladder syndrome. It typically causes symptoms of bladder and pelvic pain, an increased urge to pass urine and excessive urination during both day and night. The cause of the condition is not well-understood but it is thought to result from long-standing inflammation of the bladder. Many treatments have been used for PBS/IC and in this review we assess the effects of putting medication directly into the bladder (bladder instillations) to treat it.

We found nine studies that addressed this question, assessing six different types of treatment and involving 616 participants. For none of the instillations was the evidence conclusive. It was most promising for BCG (a type of tuberculosis bacterium) and possibly also for oxybutinin (a drug commonly taken orally to stop unwanted bladder contractions). Another agent, Resiniferatoixin, seemed to worsen pain and increase the likelihood of patients stopping treatment early. Little evidence was found for assessing benefits and harms of other treatments instilled into the bladder.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

膀胱疼痛症候群/間質性膀胱炎的膀胱灌注治療

膀胱疼痛症候群(painful bladder syndrome)/間質性膀胱炎(interstitial cystitis)(PBS/IC)多出現在女性身上。我們對該症候群所知有限,其出現的症狀有膀胱痛、頻尿、尿急和夜尿。。治療膀胱疼痛症候群/間質性膀胱炎的方式包含飲食和生活方式的介入、口服藥物、膀胱灌注治療,以及一些手術的例子。其成功率有限,且對於這種情形的最佳治療方式意見並不一致。

目標

評估膀胱灌注對膀胱疼痛症候群/間質性膀胱炎的治療效果。

搜尋策略

我們搜尋了考科藍實證醫學資料庫 (2006年5月30日)以及試驗列出的參考文獻。在此領域中被認可的研究者也提供了額外的相關資料。

選擇標準

選用臨床診斷為膀胱疼痛症候群/間質性膀胱炎的參與者,及至少1個部門的試驗是用膀胱內注射來治療的隨機和半隨機臨床試驗。結果測量方式是預先決定的,主要是評估對疼痛及膀胱容積的效果。其它包含了症狀對於治療的反應、生活品質的評估、經濟因素及副作用。

資料收集與分析

2位評論者分別評估試驗的合適性及品質,接著從研究中選用相關的數據。

主要結論

9個合格的試驗包含−6個類似的組別,1個不完全交叉試驗及2個交叉試驗總共包含了616位參與者。6個試驗比較了‘活性’注射與安慰性注射,2個比較了不同型態的注射,以及1個比較了注射加上膀胱訓練和單獨使用膀胱訓練的差異。總而言之,這篇回顧文章包含6個不同型態膀胱內注射的試驗:辣椒辣素類似物(Resiniferatoxin)、二甲基亞?(Dimethyl sulfoxide)、卡界苗(BCG)、聚戊醣多硫化鈉(pentosan polysulphate)、奧昔布寧(oxybutin)、鹼化尿液(alkalinization)的酸鹼值。信賴區間(confidence intervals)很廣。辣椒辣素類似物與這篇文章結果中提到的持續差異無關,但在注射時及停止治療時會造成疼痛是比較常的現象。所得的關於二甲基亞?(DMSO)的資料非常有限,且跟安慰劑組相較沒有明顯差異。用卡介苗治療的組別似乎被報導有較少的疼痛及一般症狀。雖然副作用也常被發現,但相較安慰劑組並無差異。少數的資料顯示聚戊醣多硫化鈉有治療效果,但信賴區間很廣; 對於其副作用只有極少的資料。奧昔布寧注射會增加膀胱容積,減少頻尿,改善生活品質,並有較少的中途退出治療者。鹼化尿液酸鹼值沒有任何明顯的差異,但可能有較廣的信賴區間。

作者結論

總而言之,實證資料顯示使用膀胱內注射藥劑治療膀胱疼痛症候群/間質性膀胱炎是有限制的,且統合分析的結果會因結果測量的變異性而降低。試驗的品質參差不齊,且在某些例子中排除了任何有意義的數據。卡界苗和奧昔布寧反映出有好的耐受性,且證據顯示其效果被看好。辣椒辣素類似物沒有證據顯示其結果治療效果,且其會造成疼痛,這也降低了治療的尊醫囑性。只有極少的證據針對此篇文章提及的其它治療。隨機臨床試驗仍然需要,且研究設計必須包含膀胱疼痛症候群/間質性膀胱炎的相關結果,也必須被標準化。

翻譯人

本摘要由中國醫藥大學附設醫院陳惠萱翻譯。

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

總結

膀胱疼痛症候群/間質性膀胱炎的膀胱灌注治療。間質性膀胱炎也就是膀胱疼痛症候群。其造成的典型症狀為膀胱及骨盆痛、尿急、夜間及日間頻尿。造成此現象的原因不清楚,但可能肇因於長時間的膀胱發炎。針對膀胱疼痛症候群/間質性膀胱炎有很多的治療被運用,在這篇文章中,我們評估了直接放置藥物於膀胱中(膀胱灌注治療)的治療效果。我們發現有9個研究探討了這個問題,評估了6個不同型態的治療且包含了616個參與試驗者。沒有一種灌注治療有明確療效。有希望的治療為卡介苗(一種結核桿菌)以及奧昔布寧(一種常用來阻止非自主膀胱收縮的口服藥)。另1種藥劑,即辣椒辣素類似物,可能會加重疼痛,以及增加病人早期停止治療的可能性。而評估其它膀胱注射的治療之益處與害處,只有極少的證據被發現。