Royal London Hospital, Academic Unit of Surgery, Centre for Digestive Diseases, 3rd Floor Alexandra Wing, Barts and The London NHS Trust, Whitechapel, London E1 1BB, United Kingdom.
Dis Colon Rectum. 2011 Oct;54(10):1271-8. doi: 10.1097/DCR.0b013e3182270af1.
Sacral nerve stimulation has been shown to be an effective treatment for fecal incontinence and early studies reported success rates of 67% to 100%. However, "success" has been arbitrarily set at a 50% reduction in symptoms, and data are rarely reported with "intention to treat."
This study aimed to assess the true efficacy of sacral nerve stimulation for fecal incontinence compared with the published literature.
This prospective 5-year study was conducted to assess 50 patients with fecal incontinence treated with sacral nerve stimulation. All analyses were performed on an intention-to-treat basis.
This study took place in a single tertiary referral colorectal department.
Fifty consecutive patients with fecal incontinence refractory to conservative management were included in the study.
The interventions performed were temporary evaluation with or without permanent sacral nerve stimulation.
: Primary outcome measures were 1) attainment of continence, 2) reduction in fecal incontinence episodes, 3) improvement in Cleveland Clinic Fecal Incontinence scores, and 4) improvement in the ability to defer defecation.
Thirteen patients (26%) did not respond at the temporary evaluation stage or were dissatisfied with the result. Ten further patients (20%) did not achieve a 50% reduction in symptoms following permanent implantation. The median follow-up was 17 months (range, 2-55), at which time 27 patients (54%) experienced a 50% or more reduction in symptoms, including 13 (26%) who achieved apparent continence. Median fecal incontinence episodes per fortnight reduced from 14 (range, 0-53) to 2 (range, 0-20; P < .0001). Median Cleveland Clinic Fecal Incontinence scores reduced from 15 (range, 3-20) to 8 (range, 0-17; P < .0001). The ability to defer defecation improved significantly (P < .0001). These results compare favorably with the published literature.
Quality of life was not assessed.
This study demonstrates that sacral nerve stimulation can be an effective treatment for patients with fecal incontinence; however, when analyzed by intention to treat, the symptoms of fecal incontinence continue in the majority (74%) of patients.
骶神经刺激已被证明是治疗粪便失禁的有效方法,早期研究报告的成功率为 67%至 100%。然而,“成功”被任意设定为症状减轻 50%,并且很少有数据以“意向治疗”报告。
本研究旨在评估与已发表文献相比,骶神经刺激治疗粪便失禁的真实疗效。
这项前瞻性 5 年研究评估了 50 例接受骶神经刺激治疗的粪便失禁患者。所有分析均基于意向治疗进行。
这项研究在一家单一的三级转诊肛肠科进行。
50 例连续粪便失禁患者,经保守治疗无效,纳入研究。
进行的干预措施包括临时评估(包括或不包括永久性骶神经刺激)。
主要观察指标为 1)达到节制,2)减少粪便失禁发作,3)改善克利夫兰诊所粪便失禁评分,4)延迟排便能力改善。
13 例患者(26%)在临时评估阶段无反应或对结果不满意。另外 10 例患者(20%)在永久性植入后未达到症状减轻 50%。中位随访时间为 17 个月(范围,2-55),此时 27 例患者(54%)症状减轻 50%或更多,包括 13 例(26%)患者明显节制。每两周粪便失禁发作次数中位数从 14 次(范围,0-53 次)减少至 2 次(范围,0-20 次;P<.0001)。克利夫兰诊所粪便失禁评分中位数从 15 分(范围,3-20 分)降至 8 分(范围,0-17 分;P<.0001)。延迟排便能力显著改善(P<.0001)。这些结果与已发表的文献相比具有优势。
未评估生活质量。
本研究表明,骶神经刺激可有效治疗粪便失禁患者;然而,按意向治疗分析,粪便失禁症状在大多数(74%)患者中仍持续存在。