Department of OBGYN, Division of Urogynecology, Duke University Medical Center, Durham, North Carolina, USA.
Department of Biostatistics & Bioinformatics, Duke University, Durham, North Carolina, USA.
Neurourol Urodyn. 2022 Jan;41(1):432-447. doi: 10.1002/nau.24845. Epub 2021 Dec 2.
Develop models to predict outcomes after intradetrusor injection of 100 or 200 units of onabotulinumtoxinA in women with non-neurogenic urgency urinary incontinence (UUI).
Models were developed using 307 women from two randomized trials assessing efficacy of onabotulinumtoxinA for non-neurogenic UUI. Cox, linear and logistic regression models were fit using: (1) time to recurrence over 12 months, (2) change from baseline daily UUI episodes (UUIE) at 6 months, and (3) need for self-catheterization over 6 months. Model discrimination of Cox and logistic regression models was calculated using c-index. Mean absolute error determined accuracy of the linear model. Calibration was demonstrated using calibration curves. All models were internally validated using bootstrapping.
Median time to recurrence was 6 (interquartile range [IQR]: 2-12) months. Increasing age, 200 units of onabotulinumtoxinA, higher body mass index (BMI) and baseline UUIE were associated with decreased time to recurrence. The c-index was 0.63 (95% confidence interval [CI]: 0.59, 0.67). Median change in daily UUIE from baseline at 6 months was -3.5 (IQR: -5.0, -2.3). Increasing age, lower baseline UUIE, 200 units of onabotulinumtoxinA, higher BMI and IIQ-SF were associated with less improvement in UUIE. The mean absolute error predicting change in UUIE was accurate to 1.6 (95% CI: 1.5, 1.7) UUI episodes. The overall rate of self-catheterization was 17.6% (95% CI: 13.6%-22.4%). Lower BMI, 200 units of onabotulinumtoxinA, increased baseline postvoid residual and maximum capacity were associated with higher risk of self-catheterization. The c-index was 0.66 (95% CI: 0.61, 0.76). The three calculators are available at http://riskcalc.duke.edu.
After external validation, these models will assist clinicians in providing more accurate estimates of expected treatment outcomes after onabotulinumtoxinA for non-neurogenic UUI in women.
建立模型以预测在非神经源性急迫性尿失禁（UUI）女性中使用 100 或 200 单位的肉毒毒素 A 进行膀胱内注射后的结局。
使用两项评估肉毒毒素 A 治疗非神经源性 UUI 疗效的随机试验中的 307 名女性来建立模型。使用 Cox、线性和逻辑回归模型来拟合：（1）12 个月内复发时间，（2）6 个月时与基线相比每日 UUI 发作（UUIE）的变化，以及（3）6 个月内需要自我导尿。使用 C 指数计算 Cox 和逻辑回归模型的区分度。线性模型的平均绝对误差确定了准确性。通过校准曲线证明了校准。所有模型均使用自举法进行内部验证。
中位复发时间为 6 个月（四分位距 [IQR]：2-12）。年龄增长、200 单位肉毒毒素 A、较高的体重指数（BMI）和基线 UUIE 与复发时间缩短相关。C 指数为 0.63（95%置信区间 [CI]：0.59，0.67）。6 个月时与基线相比每日 UUIE 的中位数变化为-3.5（IQR：-5.0，-2.3）。年龄增长、较低的基线 UUIE、200 单位肉毒毒素 A、较高的 BMI 和 IIQ-SF 与 UUIE 的改善程度降低相关。预测 UUIE 变化的平均绝对误差准确到 1.6（95%CI：1.5，1.7）个 UUI 发作。自我导尿的总发生率为 17.6%（95%CI：13.6%-22.4%）。较低的 BMI、200 单位肉毒毒素 A、增加的基线排尿后残余量和最大容量与自我导尿的风险增加相关。C 指数为 0.66（95%CI：0.61，0.76）。这三个计算器可在 http://riskcalc.duke.edu 上获得。
经过外部验证后，这些模型将有助于临床医生在为非神经源性 UUI 女性提供肉毒毒素 A 治疗后，更准确地估计预期的治疗结果。
