Lee Hyun Young, Doo Seung Whan, Yang Won Jae, Song Yun Seob, Sun Hwa Yeon, Nho Eli Jongchan, Lee Bora, Kim Jae Heon
Department of Urology, Soonchunhyang University Seoul Hospital, Soonchunhyang University Medical College, Seoul, South Korea.
Mercer Island High School, Mercer Island, WA.
Urology. 2019 Mar;125:50-57. doi: 10.1016/j.urology.2018.11.037. Epub 2018 Dec 12.
To investigate the efficacy and safety of noninvasive intravesical instillation of onabotulinum toxin-A (OBTX-A) through systematic review and meta-analysis. Recently, several studies of noninvasive intravesical instillation of OBTX-A have been published. However, its efficacy is not well validated yet compared to well-known efficacy of minimally invasive intravesical injection of OBTX-A.
Systematic review and meta-analysis were performed to evaluate the efficacy of noninvasive intravesical instillation of OBTX-A in patients with overactive bladder and interstitial cystitis/bladder pain syndrome by measuring outcomes such as urgency episode per 72 hours, frequency per 72 hours, urgency urinary incontinence, voided volume (VV), postvoided residual volume, maximum flow rate, and patient perception of bladder condition.
Six trials in 4 studies that compared instillation of OBTX-A and placebo involving 248 patients (121 experimental and 127 controls) were included for final data extraction. Instillation of OBTX-A significantly increased VV, with a mean difference of 38.48 (95% confidence interval: 76.05, 0.92) compared to the placebo group. However, other outcomes showed statistically insignificant changes. Major adverse events were not reported in the group receiving intravesical instillation of OBTX-A.
Intravesical instillation of OBTX-A showed limited efficacy with improvement of VV for treatment of overactive bladder or interstitial cystitis/bladder pain syndrome. More studies are needed to overcome the efficacy of current noninvasive bladder instillation of OBTX-A regarding effective drug transport.
通过系统评价和荟萃分析，探讨非侵入性膀胱内灌注A型肉毒毒素（OBTX - A）的疗效和安全性。最近，已经发表了几项关于非侵入性膀胱内灌注OBTX - A的研究。然而，与微创膀胱内注射OBTX - A的已知疗效相比，其疗效尚未得到充分验证。
通过测量每72小时的尿急发作次数、每72小时的排尿频率、急迫性尿失禁、排尿量（VV）、排尿后残余尿量、最大尿流率以及患者对膀胱状况的感知等结果，进行系统评价和荟萃分析，以评估非侵入性膀胱内灌注OBTX - A对膀胱过度活动症和间质性膀胱炎/膀胱疼痛综合征患者的疗效。
纳入4项研究中的6项试验，这些试验比较了OBTX - A与安慰剂的灌注情况，涉及248例患者（121例试验组和127例对照组），用于最终数据提取。与安慰剂组相比，灌注OBTX - A显著增加了排尿量，平均差异为38.48（95%置信区间：76.05，0.92）。然而，其他结果显示在统计学上无显著变化。接受膀胱内灌注OBTX - A的组未报告重大不良事件。
膀胱内灌注OBTX - A在治疗膀胱过度活动症或间质性膀胱炎/膀胱疼痛综合征时，在改善排尿量方面显示出有限的疗效。需要更多的研究来克服当前非侵入性膀胱灌注OBTX - A在有效药物输送方面的疗效问题。
