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

Whitney K Hendrickson; Gongbo Xie; David D Rahn; Cindy L Amundsen; James A Hokanson; Megan Bradley; Ariana L Smith; Vivian W Sung; Anthony G Visco; Sheng Luo; J Eric Jelovsek

doi:10.1002/nau.24845

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

Neurourol Urodyn. 2022 Jan;41(1):432-447. doi: 10.1002/nau.24845. Epub 2021 Dec 2.

Authors

Affiliations

¹ Department of OBGYN, Division of Urogynecology, Duke University Medical Center, Durham, North Carolina, USA.
² Department of Biostatistics & Bioinformatics, Duke University, Durham, North Carolina, USA.
³ Department of OBGYN, Division of Female Pelvic Medicine and Reconstructive Surgery, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
⁴ Department of Biomedical Engineering, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
⁵ Department of Obstetrics, Gynecology and Reproductive Services, Division of Urogynecology and Pelvic Reconstructive Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
⁶ Department of Surgery, Division of Urology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁷ Department of OBGYN, Division of Urogynecology and Pelvic Reconstructive Surgery, Women and Infants Hospital, Brown University, Providence, Rhode Island, USA.

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.

Conclusions: 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.

Keywords: ABC; BoNT-A; ROSETTA; UUI; botox; prediction model; urgency urinary incontinence.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Botulinum Toxins, Type A* / therapeutic use
Female
Humans
Treatment Outcome
Urinary Bladder, Overactive* / drug therapy
Urinary Incontinence* / drug therapy
Urinary Incontinence, Urge / drug therapy

Substances

Botulinum Toxins, Type A

Abstract

Publication types

MeSH terms

Substances

Grants and funding