Predicting Risk of Urinary Incontinence and Adverse Events After Midurethral Sling Surgery in Women.

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2016-02

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Abstract

OBJECTIVE: To construct and validate models that predict a patient's risk of developing stress and urgency urinary incontinence and adverse events 12 months after sling surgery. METHODS: This was a secondary analysis of four randomized trials. Twenty-five candidate predictors (patient characteristics and urodynamic variables) were identified from the National Institute of Diabetes and Digestive and Kidney Diseases Trial of Mid-Urethral Slings (N=597). Multiple logistic models were fit to predict four different outcomes: 1) bothersome stress urinary incontinence; 2) a positive stress test; 3) bothersome urgency urinary incontinence; and 4) any adverse event up to 12 months after sling surgery. Model discrimination was measured using a concordance index. Each model's concordance index was internally validated using 1,000 bootstrap samples and calibration curves were plotted. Final models were externally validated on a separate data set (n=902) from a combination of three different multicenter randomized trials. RESULTS: Four best models discriminated on internal validation between women with bothersome stress urinary incontinence (concordance index 0.728, 95% confidence interval [CI] 0.683-0.773), a positive stress test (concordance index 0.712, 95% CI 0.669-0.758), bothersome urgency urinary incontinence (concordance index 0.722, 95% CI 0.680-0.764), and any adverse event (concordance index 0.640, 95% CI 0.595-0.681) after sling surgery. Each model's concordance index was reduced as expected when important variables were removed for external validation, but model discrimination remained stable with bothersome stress urinary incontinence (concordance index 0.548), a positive stress test (concordance index 0.656), bothersome urgency urinary incontinence (concordance index 0.621), and any adverse event (concordance index 0.567). Predicted probabilities are closest to actual probabilities when predictions are less than 50%. CONCLUSION: Four best and modified models discriminate between women who will and will not develop urinary incontinence and adverse events 12 months after midurethral sling surgery 64-73% and 55-66% of the time, respectively.

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10.1097/AOG.0000000000001269

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Jelovsek, J Eric, Audra Jolyn Hill, Kevin M Chagin, Michael W Kattan and Matthew D Barber (2016). Predicting Risk of Urinary Incontinence and Adverse Events After Midurethral Sling Surgery in Women. Obstet Gynecol, 127(2). pp. 330–340. 10.1097/AOG.0000000000001269 Retrieved from https://hdl.handle.net/10161/15135.

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Jelovsek

John E Jelovsek

F. Bayard Carter Distinguished Professor of Obstetrics and Gynecology

Dr. Jelovsek is the F. Bayard Carter Distinguished Professor of OBGYN at Duke University and serves as Director of Data Science for Women’s Health. He is Board Certified in OBGYN by the American Board of OBGYN and in Female Pelvic Medicine & Reconstructive Surgery by the American Board of OBGYN and American Board of Urology. He has an active surgical practice in urogynecology based out of Duke Raleigh. He has expertise as a clinician-scientist in developing and evaluating clinical prediction models using traditional biostatistics and machine learning approaches. These “individualized” patient-centered prediction tools aim to improve decision-making regarding the prevention of lower urinary tract symptoms (LUTS) and other pelvic floor disorders after childbirth (PMID:29056536), de novo stress urinary incontinence and other patient-perceived outcomes after pelvic organ prolapse surgery, risk of transfusion during gynecologic surgery, and urinary outcomes after mid-urethral sling surgery (PMID: 26942362). He also has significant expertise in leading trans-disciplinary teams through NIH-funded multi-center research networks and international settings. As alternate-PI for the Cleveland Clinic site in the NICHD Pelvic Floor Disorders Network, he was principal investigator on the CAPABLe trial (PMID: 31320277), one of the largest multi-center trials for fecal incontinence studying anal exercises with biofeedback and loperamide for the treatment of fecal incontinence. He was the principal investigator of the E-OPTIMAL study (PMID: 29677302), describing the long-term follow up sacrospinous ligament fixation compared to uterosacral ligament suspension for apical vaginal prolapse. He was also primary author on research establishing the minimum important clinical difference for commonly used measures of fecal incontinence. Currently, he serves as co-PI in the NIDDK Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) (U01DK097780-05) where he has been involved in studies in the development of Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) and LURN SI-10 questionnaires for men and women with LUTS. He is also the site-PI for the PREMIER trial (1R01HD105892): Patient-Centered Outcomes of Sacrocolpopexy versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse.

Barber

Matthew Don Barber

W. Allen Addison, M.D. Distinguished Professor of Obstetrics and Gynecology

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