Department of Colorectal Surgery, Cleveland Clinic Florida, Fort Lauderdale, FL, USA.
Ann Surg. 2010 Mar;251(3):441-9. doi: 10.1097/SLA.0b013e3181cf8ed0.
Sacral nerve stimulation has been approved for use in treating urinary incontinence in the United States since 1997, and in Europe for both urinary and fecal incontinence (FI) since 1994. The purpose of this study was to determine the safety and efficacy of sacral nerve stimulation in a large population under the rigors of Food and Drug Administration-approved investigational protocol.
Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial. Patients showing > or =50% improvement during test stimulation received chronic implantation of the InterStim Therapy (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that > or =50% of subjects would achieve therapeutic success, defined as > or =50% reduction of incontinent episodes per week at 12 months compared with baseline.
A total of 133 patients underwent test stimulation with a 90% success rate, and 120 (110 females) of a mean age of 60.5 years and a mean duration of FI of 6.8 years received chronic implantation. Mean follow-up was 28 (range, 2.2-69.5) months. At 12 months, 83% of subjects achieved therapeutic success (95% confidence interval: 74%-90%; P < 0.0001), and 41% achieved 100% continence. Therapeutic success was 85% at 24 months. Incontinent episodes decreased from a mean of 9.4 per week at baseline to 1.9 at 12 months and 2.9 at 2 years. There were no reported unanticipated adverse device effects associated with InterStim Therapy.
Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI.
骶神经刺激疗法自 1997 年起已获美国食品和药物管理局批准，用于治疗尿失禁；1994 年起，在欧洲，骶神经刺激疗法也被批准用于治疗尿失禁和粪便失禁。本研究旨在根据美国食品和药物管理局批准的研究方案，在大量人群中确定骶神经刺激疗法的安全性和有效性。
本研究为机构审查委员会批准的多中心前瞻性试验，入组并签署知情同意书的候选患者接受骶神经刺激测试。在测试刺激中表现出>或=50%改善的患者接受 InterStim 疗法（美敦力公司；明尼苏达州明尼阿波利斯）的慢性植入。主要疗效目标是证明>或=50%的患者将获得治疗成功，定义为与基线相比，12 个月时每周失禁发作减少>或=50%。
共有 133 例患者接受了测试刺激，成功率为 90%，120 例（110 例女性）患者的平均年龄为 60.5 岁，粪便失禁的平均持续时间为 6.8 年，接受了慢性植入。平均随访时间为 28（范围，2.2-69.5）个月。在 12 个月时，83%的患者达到治疗成功（95%置信区间：74%-90%；P<0.0001），41%的患者达到 100%的完全控便。24 个月时的治疗成功率为 85%。失禁发作次数从基线时的每周 9.4 次减少到 12 个月时的 1.9 次和 2 年时的 2.9 次。没有报道与 InterStim 疗法相关的意外不良设备效应。
使用 InterStim 疗法的骶神经刺激是治疗粪便失禁患者的一种安全有效的治疗方法。
