Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
Dis Colon Rectum. 2013 Feb;56(2):234-45. doi: 10.1097/DCR.0b013e318276b24c.
Limited data have been published regarding the long-term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence.
The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on the long-term durability of the therapy. Five-year data were analyzed.
Patients entered in a multicenter, prospective study for fecal incontinence were followed at 3, 6, and 12 months and annually after device implantation.
Patients with chronic fecal incontinence in whom conservative treatments had failed or who were not candidates for more conservative treatments were selected.
Patients with ≥ 50% improvement over baseline in fecal incontinence episodes per week during a 14-day test stimulation period received sacral nerve stimulation therapy.
Patients were assessed with a 14-day bowel diary and Fecal Incontinence Quality of Life and Fecal Incontinence Severity Index questionnaires. Therapeutic success was defined as ≥ 50% improvement over baseline in fecal incontinence episodes per week. All adverse events were collected.
A total of 120 patients (110 women; mean age, 60.5 years) underwent implantation. Seventy-six of these patients (63%) were followed a minimum of 5 years (maximum, longer than 8 years) and are the basis for this report. Fecal incontinence episodes per week decreased from a mean of 9.1 at baseline to 1.7 at 5 years, with 89% (n = 64/72) having ≥ 50% improvement (p < 0.0001) and 36% (n = 26/72) having complete continence. Fecal Incontinence Quality of Life scores also significantly improved for all 4 scales between baseline and 5 years (n = 70; p < 0.0001). Twenty-seven of the 76 (35.5%) patients required a device revision, replacement, or explant.
The therapeutic effect and improved quality of life for fecal incontinence is maintained 5 years after sacral nerve stimulation implantation and beyond. Device revision, replacement, or explant rate was acceptable, but future efforts should be aimed at improvement.
关于骶神经刺激（也称为骶神经调节）治疗严重粪便失禁的长期效果，已有有限的数据发表。
本研究旨在使用精确的工具和数据收集来评估骶神经刺激的结果，重点关注治疗的长期耐久性。分析了 5 年的数据。
患有慢性粪便失禁的患者，经保守治疗失败或不适合更保守治疗的患者，进入多中心前瞻性研究，在植入设备后 3、6 和 12 个月以及每年进行随访。
选择患有慢性粪便失禁的患者，经保守治疗失败或不适合更保守治疗的患者。
在 14 天测试刺激期间，每周粪便失禁发作次数较基线至少改善 50%的患者接受骶神经刺激治疗。
患者采用 14 天排便日记和粪便失禁生活质量问卷和粪便失禁严重程度指数问卷进行评估。治疗成功定义为每周粪便失禁发作次数较基线至少改善 50%。收集所有不良事件。
共 120 例患者（110 例女性；平均年龄 60.5 岁）接受了植入。其中 76 例（63%）患者至少随访 5 年（最长随访时间超过 8 年），为本报告的基础。每周粪便失禁发作次数从基线时的 9.1 次减少到 5 年时的 1.7 次，89%（n=64/72）患者改善≥50%（p＜0.0001），36%（n=26/72）患者完全失禁。所有 4 个量表的粪便失禁生活质量评分在基线和 5 年时均显著改善（n=70；p＜0.0001）。76 例患者中有 27 例（35.5%）需要对设备进行修改、更换或取出。
骶神经刺激植入后 5 年及以后，粪便失禁的治疗效果和生活质量改善得以维持。设备修改、更换或取出的比率是可以接受的，但未来应努力加以改进。
