Abstract

INTRODUCTION AND OBJECTIVES: Sacral neuromodulation is a highly effective therapy; however, up to 30% of patients who undergo sacral nerve stimulator (SNS) implantation will require lead revision within 5 years. Lead breakage can occur during revision, but the rate of breakage and the risk factors associated with it are not well described in the literature. The aim of this study is to describe the rate of lead breakage in our institution and identify potential risk factors for breakage. METHODS: A retrospective review of all SNS lead revisions or explantations performed in the urology department at a tertiary care center between 2010 and 2015 was performed. The clinical, demographic characteristics and lead breakage rate were analyzed. Descriptive statistics are presented as percentages, mean SD or median (interquartile range). T-test, Mann-Whitney U, Chi-Square or Fisher exact tests were used as appropriate. A logistic regression analysis was performed for incomplete lead removal as the dependent variable that included variables with p values < 0.1 in the univariate analysis as well as other clinically relevant variables. p<0.05 was considered statistically significant. RESULTS: Between 2010 and 2015, 119 patients underwent a lead revision or explantation. 116 patients were included in analysis. Patients were predominantly female (91.2%) with a mean age of 56.2 16.2 and mean BMI 29.6 7.6. Overactive bladder (OAB) was the most common indication for SNS (82.3%). The lead was removed intact in 81.9%. On univariate analysis, months since initial implantation e35.2 (15.2-59.6) vs 56.6 (52.3-79.8), p1⁄40.003; diabetic status e11.6% vs 33.3%, p1⁄40.029; and provider rate of incomplete removal ranging between 0-20%, p1⁄40.05 were independent risk factors for lead breakage. Onmultivariable analysis that included age, gender, BMI, time since implant, diabetic status and provider, only time since implantation and diabetic status were statistically significant risk factors (OR 0.98, CI 95% 0.96-0.99 and OR 3.5, CI 95% 1.05-11.5, respectively). CONCLUSIONS: The overall risk of lead breakage at the time of revision or explantation is approximately 18%. Significant risk factors that increase the rate of breakage are increased time since implantation and diabetes. These findings may be valuable for patient counseling before SNS revision. Prospective studies are needed to better identify other risks factors and to develop prevention strategies.

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