Department of Obstetrics and Gynecology, University of Rochester, School of Medicine and Dentistry, Rochester, NY, USA.
School of Medicine and Dentistry, University of Rochester, Rochester, NY, USA.
Neuromodulation. 2020 Dec;23(8):1201-1206. doi: 10.1111/ner.13050. Epub 2019 Nov 7.
This study aimed to determine the incidence and risk factors associated with revision or removal of a sacral nerve stimulation device for treatment of lower urinary tract dysfunction or fecal incontinence.
This is a single-center multidisciplinary retrospective cohort study conducted at a university hospital from January 2013 through October 2017. Subjects who underwent successful sacral neuromodulation were identified via procedural codes. Clinical and demographic data regarding device revision or removal were extracted from the medical record. When testing differences between groups, t-test or Mann-Whitney U test was used to compare continuous variables. Categorical variables were compared by Chi-square test. Risk factors with a p value <0.2 in univariate investigation were included in the multivariate analysis. Logistic regression modeling was used to compare associations between risk factors and re-operation rates.
Of the 219 subjects analyzed, 35 (16%) had revision or explantation of the sacral nerve stimulation device. Median time to re-operation was 164 days (interquartile range [IQR]: 29, 525). Subjects with device revised or explanted were younger, with a median age of 50 years vs. 62 years (p < 0.01) for those who did not undergo explantation. Patient demographics and co-morbidities were otherwise similar. Multivariate analysis identified age under 55 years (odds ratio [OR]: 2.51; 95% confidence interval [CI]: 1.18-5.33) as a significant risk factor. Our regression model showed that neither preimplantation diagnosis of chronic pain (OR: 0.60; 95% CI: 0.28-1.27) nor the specialty of the surgeon (OR 1.04; 95% CI 0.66-1.62) was associated with stimulation device revision or explantation.
This study found a 16% incidence of revision or explantation. Age under 55 years was identified as a significant risk factor. Our analysis did not find further demographic characteristics, co-morbid disorders, or behavioral diagnoses that were associated with revision or removal. Identification of risk factors may aid in patient selection for sacral nerve stimulation device implantation.
本研究旨在确定因治疗下尿路功能障碍或粪便失禁而对骶神经刺激装置进行修订或移除的发生率和相关风险因素。
这是一项在 2013 年 1 月至 2017 年 10 月在一所大学医院进行的单中心多学科回顾性队列研究。通过手术代码确定成功进行骶神经调节的受试者。从病历中提取有关装置修订或移除的临床和人口统计学数据。当测试组间差异时，使用 t 检验或曼-惠特尼 U 检验比较连续变量。使用卡方检验比较分类变量。单因素分析中 p 值<0.2 的风险因素被纳入多因素分析。使用逻辑回归模型比较风险因素与再手术率之间的关联。
在分析的 219 名受试者中，有 35 名（16%）进行了骶神经刺激装置的修订或取出。再次手术的中位时间为 164 天（四分位距[IQR]：29，525）。接受修订或取出装置的受试者年龄较小，中位年龄为 50 岁，而未接受取出的受试者年龄为 62 岁（p<0.01）。患者的人口统计学和合并症在其他方面相似。多因素分析确定年龄<55 岁（优势比[OR]：2.51；95%置信区间[CI]：1.18-5.33）是一个显著的风险因素。我们的回归模型显示，植入前诊断为慢性疼痛（OR：0.60；95%CI：0.28-1.27）或外科医生的专业（OR 1.04；95%CI 0.66-1.62）均与刺激装置修订或取出无关。
本研究发现修订或取出的发生率为 16%。年龄<55 岁被确定为一个显著的风险因素。我们的分析没有发现与修订或移除相关的其他人口统计学特征、合并症或行为诊断。确定风险因素可能有助于患者选择骶神经刺激装置植入。
