METHODS: A comprehensive search of the MEDLINE, Embase, and Cochrane Central data bases was performed to find publications, excluding case reports, reporting outcomes of SNS treatment for FI in adults with ≥36 months of follow-up. Bias was assessed using the Risk of Bias in Non-randomized Studies-of Interventions tool. Data were summarized per reported FI-related outcomes for symptom severity and quality of life.
RESULTS: In total, 3326 publications were identified, and 36 studies containing 3770 subjects were included. All studies had a serious risk of bias. Success was variably defined by each publication and ranged from 59.4% to 87.5% for per-protocol analyses and 20.9% to 87.5% for intention-to-treat analyses. All studies reporting bowel diary data, St Mark\'s scores, and Cleveland Clinic Incontinence Scores indicated significant improvement with SNS treatment in the long term. Studies that evaluated quality-of-life outcomes also all showed improvements in quality of life as measured by the Fecal Incontinence Quality of Life Scale. The aggregate revision rate was 35.2%, and the explantation rate was 19.7%.
CONCLUSIONS: Improvements in objective and subjective outcomes at ≥36 months support using SNS for the long-term treatment of FI. Interpretation of these data is limited by a lack of comparative trials and heterogeneity of the included studies.
方法:对MEDLINE的全面搜索,Embase,和CochraneCentral数据库进行了查找出版物,不包括病例报告,报告随访时间≥36个月的成人SNS治疗FI的结局.使用非随机干预研究工具中的偏差风险评估偏差。根据报告的FI相关结果对症状严重程度和生活质量的数据进行总结。
结果:总计,确定了3326种出版物,36项研究纳入3770名受试者.所有研究都有严重的偏倚风险。每个出版物对成功的定义各不相同,符合方案分析的成功率为59.4%至87.5%,意向治疗分析的成功率为20.9%至87.5%。所有报告肠道日记数据的研究,圣马克的分数,和克利夫兰临床尿失禁评分表明SNS治疗的长期明显改善。评估生活质量结果的研究也都显示了通过大便失禁生活质量量表测量的生活质量的改善。总量修正率为35.2%,出苗率为19.7%。
结论:在≥36个月时客观和主观结果的改善支持使用SNS长期治疗FI。由于缺乏比较试验和纳入研究的异质性,对这些数据的解释受到限制。