Division of Reconstructive Urology and Pelvic Health, Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Department of Urology, University of California San Francisco, San Francisco, California, USA.
Neurourol Urodyn. 2022 Feb;41(2):662-671. doi: 10.1002/nau.24871. Epub 2022 Jan 12.
Onabotulinumtoxin A (BTX-A) is an effective therapy for overactive bladder (OAB), however, adverse events may prevent patients from initiating therapy. The study objective was to report real-world rates of incomplete emptying and urinary tract infection (UTI) in men and women undergoing BTX-A for OAB.
Eleven clinical sites performed a retrospective study of adults undergoing first-time BTX-A injection (100 units) for idiopathic OAB in 2016. Exclusions included: postvoid residual (PVR) > 150 ml, prior BTX-A, pelvic radiation, or need for preprocedure catheterization. Primary outcomes at 6 months were incomplete emptying (clean intermittent catheterization [CIC] or PVR ≥ 300 ml without the need for CIC); and UTI (symptoms with either positive culture or urinalysis or empiric treatment). We compared rates of incomplete emptying and UTI within and between sexes, using univariate and multivariable models.
278 patients (48 men and 230 women) met inclusion criteria. Mean age was 65.5 years (range: 24-95). 35% of men and 17% of women had incomplete emptying. Men had 2.4 (95% CI: 1.04-5.49) higher odds of incomplete emptying than women. 17% of men and 23.5% of women had ≥1 UTI, the majority of which occurred within the first month following injection. The strongest predictor of UTI was a history of prior UTI (OR: 4.2 [95% CI: 1.7-10.3]).
In this multicenter retrospective study, rates of incomplete emptying and UTI were higher than many previously published studies. Men were at particular risk for incomplete emptying. Prior UTI was the primary risk factor for postprocedure UTI.
肉毒杆菌毒素 A（BTX-A）是治疗膀胱过度活动症（OAB）的有效方法，但是，不良反应可能会使患者无法开始治疗。本研究的目的是报告男性和女性接受 BTX-A 治疗 OAB 时不完全排空和尿路感染（UTI）的真实世界发生率。
2016 年，11 个临床站点对首次接受 BTX-A（100 单位）注射治疗特发性 OAB 的成人进行了回顾性研究。排除标准包括：残余尿量（PVR）>150ml、既往 BTX-A、盆腔放疗或需要术前导尿。6 个月时的主要结局为不完全排空（清洁间歇导尿[CIC]或 PVR≥300ml 但无需 CIC）；以及 UTI（有症状且培养或尿液分析阳性或经验性治疗）。我们使用单变量和多变量模型比较了不同性别之间和之内不完全排空和 UTI 的发生率。
278 名患者（48 名男性和 230 名女性）符合纳入标准。平均年龄为 65.5 岁（范围：24-95）。35%的男性和 17%的女性有不完全排空。男性不完全排空的可能性是女性的 2.4 倍（95%CI：1.04-5.49）。17%的男性和 23.5%的女性有≥1 次 UTI，其中大多数发生在注射后第一个月内。UTI 的最强预测因素是既往 UTI 史（OR：4.2[95%CI：1.7-10.3]）。
在这项多中心回顾性研究中，不完全排空和 UTI 的发生率高于许多先前发表的研究。男性排空不完全的风险特别高。既往 UTI 是术后 UTI 的主要危险因素。
