1Institut National de la Santé et de la Recherche Médicale U1073, Service de Physiologie Digestive, Centre Hospitalier Universitaire de Rouen, Institut National de la Santé et de la Recherche Médicale Centre d'Investigation Clinique 0204, Rouen, France 2Institut National de la Santé et de la Recherche Médicale U1073, Service de Chirurgie Digestive, Centre Hospitalier Universitaire de Rouen, Rouen, France 3Unité de Biostatistiques, Centre Hospitalier Universitaire de Rouen, Rouen, France.
Dis Colon Rectum. 2014 Jun;57(6):772-80. doi: 10.1097/DCR.0000000000000115.
Sacral nerve stimulation has a place in the treatment algorithm for fecal incontinence, but the predictive factors of its midterm and long-term success are unknown.
The purpose of this study was to investigate the effect of a 3-year sacral nerve stimulation treatment of fecal continence and to identify specific predictive factors from the pretreatment and per-treatment assessments for the midterm success of sacral nerve stimulation.
A cohort analysis of consecutive patients treated with sacral nerve stimulation for fecal incontinence over a period of 3 years was performed.
This study was conducted at an academic colorectal unit in a tertiary care center.
Sixty patients were available for the assessment of 3-year outcomes.
Clinical outcome (including Cleveland Clinic score) and anorectal physiological data were collected prospectively before and after treatment.
At the 3-year follow-up, 33 of the 60 implanted patients had an improved outcome as defined by a ≥30% improvement in the Cleveland Clinic score from baseline (37.1% on intention to treat and 55.0% per protocol), whereas 22 had an unsuccessful outcome as defined by a <30% improvement in the Cleveland Clinic score from baseline (24.7% on intention to treat and 36.7% per protocol), of whom 7 had their device explanted or switched off permanently before the 3-year assessment, and 3 were lost at follow-up. At 3 years, we failed to identify any factors that could predict the 3-year clinical outcome of sacral nerve stimulation based on preimplantation and postimplantation assessments.
This study involved a relatively small number of patients. There was a lack of consistency in the tool used to evaluate the efficacy of the test and permanent stimulations.
Based on per-protocol assessments, 55% of the patients had improved outcomes at the 3-year follow-up. No predictor was identified by the pretreatment and posttreatment assessments (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A133).
骶神经刺激在治疗大便失禁的治疗算法中占有一席之地，但中远期成功的预测因素尚不清楚。
本研究旨在探讨骶神经刺激治疗大便失禁 3 年的效果，并从治疗前和治疗期间的评估中确定骶神经刺激中短期成功的具体预测因素。
对在三级医疗中心的学术结直肠科单位接受骶神经刺激治疗大便失禁的连续患者进行队列分析。
该研究在学术结直肠科单位的三级医疗中心进行。
60 名患者可评估 3 年的结果。
临床结果（包括克利夫兰诊所评分）和肛门直肠生理数据在治疗前后均进行前瞻性收集。
在 3 年的随访中，60 名植入患者中有 33 名患者的结果得到改善，定义为克利夫兰诊所评分较基线至少提高 30%（意向治疗为 37.1%，按方案为 55.0%），而 22 名患者的结果无改善，定义为克利夫兰诊所评分较基线提高不到 30%（意向治疗为 24.7%，按方案为 36.7%），其中 7 名患者在 3 年评估前永久取出或关闭设备，3 名患者失访。3 年后，我们未能根据植入前和植入后评估确定任何可以预测骶神经刺激 3 年临床结果的因素。
本研究涉及的患者数量相对较少。用于评估测试和永久性刺激效果的工具缺乏一致性。
根据按方案评估，55%的患者在 3 年随访时结果得到改善。治疗前和治疗期间的评估均未发现预测因子（参见视频，补充数字内容 1，http://links.lww.com/DCR/A133）。
