Whitney K Hendrickson1, Gongbo Xie2, David D Rahn3, Cindy L Amundsen1, James A Hokanson4, Megan Bradley5, Ariana L Smith6, Vivian W Sung7, Anthony G Visco1, Sheng Luo2, J Eric Jelovsek1. 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.
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.
Authors: Daniel Liberman; Olufenwa Milhouse; Marta Johnson-Mitchell; Steven W Siegel Journal: Female Pelvic Med Reconstr Surg Date: 2018 Nov/Dec Impact factor: 2.091
Authors: J Eric Jelovsek; Kevin Chagin; Linda Brubaker; Rebecca G Rogers; Holly E Richter; Lily Arya; Matthew D Barber; Jonathan P Shepherd; Tracy L Nolen; Peggy Norton; Vivian Sung; Shawn Menefee; Nazema Siddiqui; Susan F Meikle; Michael W Kattan Journal: Obstet Gynecol Date: 2014-02 Impact factor: 7.661
Authors: Yuko M Komesu; Cindy L Amundsen; Holly E Richter; Stephen W Erickson; Mary F Ackenbom; Uduak U Andy; Vivian W Sung; Michael Albo; W Thomas Gregory; Marie Fidela Paraiso; Dennis Wallace Journal: Am J Obstet Gynecol Date: 2017-10-12 Impact factor: 8.661
Authors: Anthony G Visco; Linda Brubaker; Holly E Richter; Ingrid Nygaard; Marie Fidela R Paraiso; Shawn A Menefee; Joseph Schaffer; Jerry Lowder; Salil Khandwala; Larry Sirls; Cathie Spino; Tracy L Nolen; Dennis Wallace; Susan F Meikle Journal: N Engl J Med Date: 2012-10-04 Impact factor: 91.245
Authors: Katherine E Hartmann; Melissa L McPheeters; Danie H Biller; Renée M Ward; J Nikki McKoy; Rebecca N Jerome; Sandra R Micucci; Laura Meints; Jill A Fisher; Theresa A Scott; James C Slaughter; Jeffrey D Blume Journal: Evid Rep Technol Assess (Full Rep) Date: 2009-08