Truzzi Jose C, Lapitan Marie C, Truzzi Natassia C, Iacovelli Valerio, Averbeck Marcio A
Department of Urology, Instituto de Cancer Arnaldo Vieira de Carvalho, Sao Paulo, Brazil.
Urologist Medical Affairs Division, Federal University of Sao Paulo, Sao Paulo, Brazil.
Neurourol Urodyn. 2022 Mar;41(3):710-723. doi: 10.1002/nau.24879. Epub 2022 Feb 3.
We sought to systematically review the literature on the use of botulinum toxin (BTX-A) injections in the bladder to treat overactive bladder (OAB) in men.
A systematic review was performed to identify clinical trials on efficacy and safety of BTX-A injections in the detrusor for treatment of OAB in men published from inception to October 2020. Quality assessment was performed using the Cochrane Collaboration's tool for assessing risk of bias and study characteristics were extracted by two reviewers independently.
After screening 75 abstracts, 12 trials were included in the qualitative synthesis, of which 6 were conducted exclusively in men (mean age: 66.7 years). Only two were randomized controlled studies and the remaining were observational studies, mostly case series. Total number of participants in each study ranged from 28 to 146. Therapeutic response to intravesical BTX-A injection was assessed differently across the studies, which used quality-of-life symptom questionnaires and voiding diary parameters. Urodynamics findings were reported separately for men before and after intravesical injection of BTX-A in two studies only. Pooling of outcome data was possible with adverse events reported after BTX-A by seven studies, which showed urinary tract infection, urinary retention, increased postvoid residual, de novo interstitial cystitis, and hematuria rates of 29.8%, 20.0%, 37.3%, 28.3%, and 12.4%, respectively.
Limited information regarding the efficacy and safety of BTX-A bladder injections for male OAB from relatively low evidence is available. Further research is needed to better understand the risk-benefit profile of BTX-A in the male population.
我们旨在系统回顾有关使用肉毒杆菌毒素(BTX-A)膀胱注射治疗男性膀胱过度活动症(OAB)的文献。
进行了一项系统回顾,以确定从开始到2020年10月发表的关于BTX-A注射到逼尿肌中治疗男性OAB的疗效和安全性的临床试验。使用Cochrane协作网评估偏倚风险的工具进行质量评估,并由两名审阅者独立提取研究特征。
在筛选了75篇摘要后,12项试验被纳入定性综合分析,其中6项仅在男性中进行(平均年龄:66.7岁)。只有两项是随机对照研究,其余为观察性研究,主要是病例系列。每项研究的参与者总数从28人到146人不等。不同研究对膀胱内注射BTX-A的治疗反应评估方法不同,这些研究使用了生活质量症状问卷和排尿日记参数。仅在两项研究中分别报告了男性膀胱内注射BTX-A前后的尿动力学结果。七项研究报告了BTX-A注射后的不良事件,可对结果数据进行汇总,结果显示尿路感染、尿潴留、排尿后残余尿量增加、新发间质性膀胱炎和血尿的发生率分别为29.8%、20.0%、37.3%、28.3%和12.4%。
关于BTX-A膀胱注射治疗男性OAB的疗效和安全性的信息有限,证据相对不足。需要进一步研究以更好地了解BTX-A在男性人群中的风险效益情况。