Long-term Durability of Sacral Nerve Stimulation Therapy for Chronic Fecal Incontinence
Long-term Durability of Sacral Nerve Stimulation Therapy for Chronic Fecal Incontinence
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DOI：
10.1097/dcr.0b013e318276b24c
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发表时间：
2013-02-01
影响因子：
3.9
通讯作者：
Coller, John A.
中科院分区：
文献类型：
--
作者：
Hull, Tracy;Giese, Chad;Coller, John A.
背景技术背景：关于骶神经刺激或骶神经调节治疗严重大便失禁的长期结果，已发表的数据有限：目的是评估骶神经刺激的结果，使用精确的工具和数据收集，重点是治疗的长期持久性。设计：对进入多中心前瞻性研究的大便失禁患者在装置植入后3、6、12个月和每年随访。患者：选择保守治疗失败或不适合更保守治疗的慢性大便失禁患者。干预：在14天的测试刺激期内，每周大便失禁发作较基线改善>= 50%的患者接受骶神经刺激治疗。通过14天排便日记、粪便失禁生活质量和粪便失禁严重程度指数问卷对患者进行评估。治疗成功定义为每周大便失禁发作较基线改善>= 50%。结果：共有120例患者（110名女性，平均年龄60.5岁）接受了植入术。其中76例患者（63%）接受了至少5年（最长，超过8年）的随访，这是本报告的基础。每周大便失禁发作次数从基线时的平均9.1次减少到5年时的1.7次，89%（n = 64/72）的改善≥ 50%（p < 0.0001），36%（n = 26/72）的改善完全。从基线到5年，所有4个量表的粪便失禁生活质量评分也显著改善（n = 70; p < 0.0001）。27的76例（35.5%）患者需要一个设备的修订，更换，或explant.CONCLUSIONS：治疗效果和改善生活质量大便失禁的骶神经刺激植入后5年及以后保持。器械翻修、更换或取出率是可接受的，但未来的努力应旨在改善。
BACKGROUND: Limited data have been published regarding the long-term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence.OBJECTIVES: 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.DESIGN: Patients entered in a multicenter, prospective study for fecal incontinence were followed at 3, 6, and 12 months and annually after device implantation.PATIENTS: Patients with chronic fecal incontinence in whom conservative treatments had failed or who were not candidates for more conservative treatments were selected.INTERVENTIONS: Patients with >= 50% improvement over baseline in fecal incontinence episodes per week during a 14-day test stimulation period received sacral nerve stimulation therapy.MAIN OUTCOME MEASURES: 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.RESULTS: 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.CONCLUSIONS: 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.