Dmochowski Roger, Chapple Christopher, Gruenenfelder Jennifer, Yu Jun, Patel Anand, Nelson Mariana, Rovner Eric
Vanderbilt University Medical Center, Nashville, TN, USA.
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Eur Urol Open Sci. 2023 Oct 17;57:98-105. doi: 10.1016/j.euros.2023.09.013. eCollection 2023 Nov.
Transient increases in postvoid residual urine volume (PVR) requiring clean intermittent catheterization (CIC) have occurred with onabotulinumtoxinA treatment for overactive bladder (OAB).
To evaluate onabotulinumtoxinA safety and the effect of age, gender, and maximum PVR (PVR) on CIC initiation in adults with OAB and urinary incontinence (UI).
This was a pooled post hoc analysis of four placebo-controlled, multicenter randomized trials that included adults with idiopathic OAB after first onabotulinumtoxinA treatment (NCT00910845, NCT00910520, NCT01767519, NCT01945489). Patients had at least three urgency UI episodes over 3 d and at least eight micturitions per day, had inadequate management with at least one anticholinergic agent, and were willing to use CIC.
We measured the following outcomes: PVR within 12 wk after first treatment; CIC incidence; estimated functional capacity; PVR ratio (PVR/estimated functional capacity).
Of 1504 patients, 87.7% were women and 88.8% were White. The mean age was 60.5 yr across 10-yr age groups, baseline PVR was 13.8-35.0 ml, and estimated functional capacity was 293.5-475.7 ml. Mean baseline PVR was 21.3 ml overall versus 34.0 ml in the group that started CIC. The CIC incidence was 6.2% for women (range 1.1-8.4%) and 10.5% for men (range 0-14.6%). Higher CIC rates were observed for PVR >350 ml (women 91.9%, men 84.6%) in comparison to PVR of 201-350 ml (women 32.5%, men 17.4%) and PVR <200 ml (women 1.2%, men 1.6%). Overall, 2/1504 patients (both women) were unable to void spontaneously. The mean PVR ratio was highest at week 2. Some subgroups had small sample sizes.
CIC incidence was low overall, was less frequent for women, was rare with PVR ≤200 ml, and did not appear to correlate with baseline PVR.
After onabotulinumtoxinA treatment for OAB, patients sometimes insert a catheter to help in emptying their bladder after urinating. In this study, few patients needed a catheter, especially when less urine volume remained after urination.
使用A型肉毒毒素治疗膀胱过度活动症（OAB）时，会出现排尿后残余尿量（PVR）短暂增加，需要进行清洁间歇性导尿（CIC）。
评估A型肉毒毒素的安全性，以及年龄、性别和最大PVR对患有OAB和尿失禁（UI）的成年人开始进行CIC的影响。
设计、场所和参与者：这是一项对四项安慰剂对照、多中心随机试验的汇总事后分析，试验对象为首次接受A型肉毒毒素治疗后的特发性OAB成年人（NCT00910845、NCT00910520、NCT01767519、NCT01945489）。患者在3天内至少有3次急迫性UI发作，每天至少排尿8次，至少一种抗胆碱能药物治疗效果不佳，且愿意使用CIC。
我们测量了以下结局：首次治疗后12周内的PVR；CIC发生率；估计功能容量；PVR比率（PVR/估计功能容量）。
1504例患者中，87.7%为女性，88.8%为白人。10岁年龄组的平均年龄为6岁，基线PVR为13.8 - 35.0毫升，估计功能容量为293.5 - 475.7毫升。总体平均基线PVR为21.3毫升，而开始CIC的组为34.0毫升。女性CIC发生率为6.2%（范围1.1 - 8.4%），男性为10.5%（范围0 - 14.6%）。与PVR为201 - 350毫升（女性32.5%，男性17.4%）和PVR < 200毫升（女性1.2%，男性1.6%）相比，PVR > 350毫升时CIC发生率更高（女性91.9%，男性84.6%）。总体而言，1504例患者中有2例（均为女性）无法自主排尿。平均PVR比率在第2周时最高。一些亚组样本量较小。
总体CIC发生率较低，女性较少见，PVR≤200毫升时罕见，且似乎与基线PVR无关。
用A型肉毒毒素治疗OAB后，患者有时会在排尿后插入导尿管以帮助排空膀胱。在本研究中，很少有患者需要导尿管，尤其是排尿后剩余尿量较少时。
