Randomized, controlled trial of anal electrical stimulation for fecal incontinence
Randomized, controlled trial of anal electrical stimulation for fecal incontinence
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DOI：
10.1007/s10350-005-0251-1
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发表时间：
2006-02-01
影响因子：
3.9
通讯作者：
Kamm, MA
中科院分区：
文献类型：
--
作者：
Norton, C;Gibbs, A;Kamm, MA
目的：在几个病例系列中，肛门电刺激被描述为对大便失禁有效，但没有研究探讨可能的获益机制。我们希望检查与“假”电刺激相比，在没有任何辅助练习或建议的情况下每天在家使用肛门探针电极进行肛门电刺激八周是否会改善大便失禁和肛门括约肌压力的症状。方法：将 90 名中位年龄为 55 岁（范围为 30 - 77 岁）的患者（9 名男性，81 名女性）随机分组， 47 表示 35 Hz 的主动肛门刺激，43 表示 1 Hz 的“假”刺激。结果测量包括一周肠道日记、症状问卷、测压和患者对结果的评估。结果：70 名患者完成了研究。根据意向治疗分析，八周后两组的任何结果指标均无差异。在完成刺激的人中，44 人（63%）认为刺激改善了他们的失禁能力。那些肛门括约肌完整的人不太可能比那些括约肌破坏的人更积极地评价其变化（P = 0.71）。患者肠道控制评分中位数从刺激前的 3 分（满分 10 分）增加到刺激后的 5 分（满分 10 分）（P = 0.001）。结论：八周的肛门电刺激被患者评为在一定程度上改善了肠道控制。各组之间没有检测到统计学上的显着差异，表明 1 Hz 与 35 Hz 一样有效。这就提出了一种可能性，即主要影响不是括约肌收缩，而是患者对肛门区域的敏感性，或者仅仅是干预本身的影响。在大便失禁的保守治疗中，家庭电刺激是一种相对便宜且通常耐受性良好的疗法。
PURPOSE: Anal electric stimulation has been described as effective for fecal incontinence in several case series, but no study has addressed possible mechanism of benefit. We wished to examine whether anal electric stimulation, using an anal probe electrode, used on a daily basis at home for eight weeks, in the absence of any adjunctive exercises or advice, would improve symptoms of fecal incontinence and anal sphincter pressures when compared with "sham'' electric stimulation. METHODS: Ninety patients (9 males, 81 females), with median age of 55 (range, 30 - 77) years were randomized, 47 to active anal stimulation at 35 Hz and 43 to "sham'' stimulation at 1 Hz. Outcome measures included a one-week bowel diary, symptom questionnaire, manometry, and patients' evaluation of outcome. RESULTS: Seventy patients completed the study. On an intention-to-treat analysis, there was no difference between the two groups on any of the outcome measures after eight weeks. Of those who completed stimulation, 44 (63 percent) felt the stimulation had improved their continence. Those with intact anal sphincters were not likely to rate their change more positively than those with sphincter disruption (P = 0.71). Median patient rating of bowel control increased from 3 of 10 before stimulation to 5 of 10 after stimulation (P = 0.001). CONCLUSIONS: Eight weeks of anal electric stimulation was rated by patients as having improved their bowel control to a modest extent. There was no statistically significant difference detected between the groups, suggesting that 1 Hz was as effective as 35 Hz. This raises the possibility that the main effect is not sphincter contraction but sensitization of the patient to the anal area, or simply the effect of intervening per se. Home electric stimulation is a relatively cheap and generally well- tolerated therapy in the conservative treatment of fecal incontinence.