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Abstract：
UNASSIGNED: Transient increases in postvoid residual urine volume (PVR) requiring clean intermittent catheterization (CIC) have occurred with onabotulinumtoxinA treatment for overactive bladder (OAB).
UNASSIGNED: To evaluate onabotulinumtoxinA safety and the effect of age, gender, and maximum PVR (PVRmax) on CIC initiation in adults with OAB and urinary incontinence (UI).
UNASSIGNED: 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.
UNASSIGNED: We measured the following outcomes: PVRmax within 12 wk after first treatment; CIC incidence; estimated functional capacity; PVR ratio (PVR/estimated functional capacity).
UNASSIGNED: 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 PVRmax >350 ml (women 91.9%, men 84.6%) in comparison to PVRmax of 201-350 ml (women 32.5%, men 17.4%) and PVRmax <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.
UNASSIGNED: CIC incidence was low overall, was less frequent for women, was rare with PVRmax ≤200 ml, and did not appear to correlate with baseline PVR.
UNASSIGNED: 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.
UNASSIGNED: To evaluate onabotulinumtoxinA safety and the effect of age, gender, and maximum PVR (PVRmax) on CIC initiation in adults with OAB and urinary incontinence (UI).
UNASSIGNED: 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.
UNASSIGNED: We measured the following outcomes: PVRmax within 12 wk after first treatment; CIC incidence; estimated functional capacity; PVR ratio (PVR/estimated functional capacity).
UNASSIGNED: 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 PVRmax >350 ml (women 91.9%, men 84.6%) in comparison to PVRmax of 201-350 ml (women 32.5%, men 17.4%) and PVRmax <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.
UNASSIGNED: CIC incidence was low overall, was less frequent for women, was rare with PVRmax ≤200 ml, and did not appear to correlate with baseline PVR.
UNASSIGNED: 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.
摘要：
■对于膀胱过度活动症（OAB），需要清洁间歇性导管插入术（CIC）的后尿残余尿量（PVR）出现了短暂增加。
■为了评估甲abotulintoxinA的安全性和年龄的影响，性别,OAB和尿失禁（UI）的成人在CIC开始时的最大PVR（PVRmax）。
■这是四个安慰剂对照的汇总事后分析，多中心随机试验,纳入首次接受单纯性内毒素A治疗后患有特发性OAB的成人患者(NCT00910845,NCT00910520,NCT01767519,NCT01945489)。患者在3d内至少有3次紧急UI发作，每天至少有8次排尿。至少有一种抗胆碱能药物管理不足，并愿意使用C.
■我们测量了以下结果：首次治疗后12周内的PVRmax；CIC发生率；估计的功能容量；PVR比率（PVR/估计的功能容量）。
■1504名患者，87.7%是女性，88.8%是白人。10岁年龄组的平均年龄为60.5岁，基线PVR为13.8-35.0ml，估计功能容量为293.5-475.7毫升。总体平均基线PVR为21.3ml，而开始CIC组的平均基线PVR为34.0ml。女性的CIC发生率为6.2％（范围1.1-8.4％），男性为10.5％（范围0-14.6％）。PVRmax>350ml时观察到较高的CIC率(女性91.9%，男性84.6%)，而PVRmax为201-350毫升(女性32.5%，男性17.4%)和PVRmax<200毫升(女性1.2%，男性1.6%)。总的来说,2/1504患者（均为女性）无法自发排尿。平均PVR比率在第2周最高。一些亚组的样本量较小。
■CIC发病率总体较低，对女性来说不太常见，在PVRmax≤200毫升时很少见，并且似乎与基线PVR无关。
■在对OAB进行奥托霉素A治疗后，患者有时会在排尿后插入导管以帮助排空膀胱。在这项研究中,很少有病人需要导管，尤其是排尿后尿量较少。
■为了评估甲abotulintoxinA的安全性和年龄的影响，性别,OAB和尿失禁（UI）的成人在CIC开始时的最大PVR（PVRmax）。
■这是四个安慰剂对照的汇总事后分析，多中心随机试验,纳入首次接受单纯性内毒素A治疗后患有特发性OAB的成人患者(NCT00910845,NCT00910520,NCT01767519,NCT01945489)。患者在3d内至少有3次紧急UI发作，每天至少有8次排尿。至少有一种抗胆碱能药物管理不足，并愿意使用C.
■我们测量了以下结果：首次治疗后12周内的PVRmax；CIC发生率；估计的功能容量；PVR比率（PVR/估计的功能容量）。
■1504名患者，87.7%是女性，88.8%是白人。10岁年龄组的平均年龄为60.5岁，基线PVR为13.8-35.0ml，估计功能容量为293.5-475.7毫升。总体平均基线PVR为21.3ml，而开始CIC组的平均基线PVR为34.0ml。女性的CIC发生率为6.2％（范围1.1-8.4％），男性为10.5％（范围0-14.6％）。PVRmax>350ml时观察到较高的CIC率(女性91.9%，男性84.6%)，而PVRmax为201-350毫升(女性32.5%，男性17.4%)和PVRmax<200毫升(女性1.2%，男性1.6%)。总的来说,2/1504患者（均为女性）无法自发排尿。平均PVR比率在第2周最高。一些亚组的样本量较小。
■CIC发病率总体较低，对女性来说不太常见，在PVRmax≤200毫升时很少见，并且似乎与基线PVR无关。
■在对OAB进行奥托霉素A治疗后，患者有时会在排尿后插入导管以帮助排空膀胱。在这项研究中,很少有病人需要导管，尤其是排尿后尿量较少。
