Intravesical treatments for painful bladder syndrome/ interstitial cystitis
Editorial Group: Cochrane Incontinence Group
Published Online: 17 OCT 2007
Assessed as up-to-date: 20 AUG 2007
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
- Publication Status: Edited (no change to conclusions)
- Published Online: 17 OCT 2007
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.
To assess the effectiveness of intravesical treatment for PBS/IC.
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.
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.
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.
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
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.
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。
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。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。