Predicting outcomes after intradetrusor onabotulinumtoxina for non‐neurogenic urgency incontinence in women

Abstract

Aims: Develop models to predict outcomes after intradetrusor injection of 100 or 200 units of onabotulinumtoxinA in women with non-neurogenic urgency urinary incontinence (UUI).Methods: 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.Results: 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.

Delivering patient‐centered care through shared decision making in overactive bladder

“…30,31 At least five studies have analyzed whether demographic or urodynamic factors can predict success or complications from BTX injection. [32][33][34][35][36] In studies including men and women, women are more likely to have successful outcomes. [33][34][35] No urodynamic variables have been consistently linked F I G U R E 1 Proposed paradigm for incorporating Everyday SDM in overactive bladder (OAB) treatment pathways.…”

“…36 The authors also created a model to predict the median change in daily urge incontinence episodes as well as the risk of catheterization. 36 A machine learning algorithm based on the ROSETTA trial was recently found to be superior to expert urologists at predicting BTX outcomes and noninferior to expert urologists at predicting SNM outcomes. 37 Together, this shows that researchers are moving towards clinically accessible data to guide personalized discussions for OAB care, though more research in this space is needed.…”

“…Studies evaluating predictors of treatment success for SNM have not found any consistent predictive factors 30,31 . At least five studies have analyzed whether demographic or urodynamic factors can predict success or complications from BTX injection 32–36 . In studies including men and women, women are more likely to have successful outcomes 33–35 .…”

Clinical Application of Botulinum Neurotoxin in Lower-Urinary-Tract Diseases and Dysfunctions: Where Are We Now and What More Can We Do?

“…Repeated Botox injections have been reported to have a similar effect, and the interinjection interval has been reported to remain unchanged for up to five injections [ 15 ]. However, increasing age, a Botox dose of 200 U, higher body-mass index, and baseline UUI episodes were found to be associated with a shorter time to UUI recurrence after Botox injection [ 16 ]. In patients who have diminished Botox effect on OAB symptoms, adding mirabegron could increase the therapeutic effects, mainly on OAB symptoms and the Global Response Assessment scale [ 17 ].…”

Commentary on “Predicting outcomes after intradetrusor onabotulinumtoxinA for nonneurogenic urgency incontinence in women”

“…In their recent investigation, Hendrickson et al sought to develop predictive models for onabotuli-numtoxinA treatment response. 1 They analyzed datasets from the ABC and ROSETTA trials and, using multiple variables, developed models using Cox, linear, and logistic regression to predict outcomes. Outcomes included time to recurrence, change in number of urge urinary incontinence episodes, and post-procedural urinary retention.…”