抗膽堿能藥物和A型肉毒桿菌毒素被用于治療急迫性尿失禁，但目前尚需要直接比較這兩種治療的數(shù)據(jù)。

　　我們進行了一項雙盲、雙安慰劑對照的隨機試驗，試驗納入了患特發(fā)性急迫性尿失禁，每3天發(fā)作急迫性尿失禁≥5次（在日記中記錄）的女性。在6個月期間，我們將參與者隨機分配接受每日口服抗膽堿能藥物（索利那新，初始5 mg，可能增至10 mg，如有需要接下來改為曲司氯銨XR 60 mg）加逼尿肌內注射（生理）鹽水一次或逼尿肌內注射100 U A型肉毒桿菌毒素一次加每日口服安慰劑。主要轉歸為在6個月期間每日的急迫性尿失禁平均發(fā)作次數(shù)較基線時的減少值（按每月提交的3天日記中的記錄）。次要轉歸包括急迫性尿失禁完全緩解、生活質量、導尿管使用以及不良反應。

　　在進行隨機分組的249名女性中，247名接受了治療，241名有可用于主要轉歸分析的數(shù)據(jù)。在6個月期間，抗膽堿能組每日急迫性尿失禁發(fā)作次數(shù)由基線時的平均每天5.0次平均減少3.4次，A型肉毒桿菌毒素組平均每天減少3.3次（P＝0.81）。分別有13%和27%的女性報告急迫性尿失禁完全緩解（P＝0.003）。兩組急迫性尿失禁患者的生活質量均有改善，沒有顯著組間差異。抗膽堿能組口干的發(fā)生率更高（46%對31%，P＝0.02），但2個月時的導尿管使用率（0%對5%，P＝0.01）和尿路感染發(fā)生率更低（13%對33%，P＜0.001）。

　　口服抗膽堿能治療和注射A型肉毒桿菌毒素與急迫性尿失禁每日發(fā)作頻率降低程度相似有關。接受A型肉毒桿菌毒素組發(fā)生口干的可能性較小，出現(xiàn)急迫性尿失禁完全緩解的可能性更大，但一過性尿潴留和尿路感染發(fā)生率更高。

　　Anticholinergic Therapy vs. OnabotulinumtoxinA for Urgency Urinary Incontinence

　　Background

　　Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinaryincontinence, but data directly comparing the two types of therapy are needed.

　　Methods

　　We performed a double-blind, double-placebo–controlled, randomized trial involvingwomen with idiopathic urgency urinary incontinence who had five or more episodesof urgency urinary incontinence per 3-day period, as recorded in a diary. For a6-month period, participants were randomly assigned to daily oral anticholinergicmedication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, ifnecessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injectionof saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus dailyoral placebo. The primary outcome was the reduction from baseline in mean episodesof urgency urinary incontinence per day over the 6-month period, as recorded in3-day diaries submitted monthly. Secondary outcomes included complete resolutionof urgency urinary incontinence, quality of life, use of catheters, and adverse events.

　　Results

　　Of 249 women who underwent randomization, 247 were treated, and 241 had dataavailable for the primary outcome analyses. The mean reduction in episodes of urgencyurinary incontinence per day over the course of 6 months, from a baselineaverage of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinAgroup (P = 0.81). Complete resolution of urgency urinary incontinencewas reported by 13% and 27% of the women, respectively (P = 0.003). Quality of lifeimproved in both groups, without significant between-group differences. The anticholinergicgroup had a higher rate of dry mouth (46% vs. 31%, P = 0.02) but lowerrates of catheter use at 2 months (0% vs. 5%, P = 0.01) and urinary tract infections(13% vs. 33%, P<0.001).

　　Conclusions

　　Oral anticholinergic therapy and onabotulinumtoxinA by injection were associatedwith similar reductions in the frequency of daily episodes of urgency urinary incontinence.The group receiving onabotulinumtoxinA was less likely to have dry mouthand more likely to have complete resolution of urgency urinary incontinence buthad higher rates of transient urinary retention and urinary tract infections. (Funded bythe Eunice Kennedy Shriver National Institute of Child Health and Human Developmentand the National Institutes of Health Office of Research on Women’s Health;ClinicalTrials.gov number, NCT01166438.)