Translumbosacral Neuromodulation Therapy for Fecal Incontinence: A Randomized Frequency Response Trial.
Translumbosacral Neuromodulation Therapy for Fecal Incontinence: A Randomized Frequency Response Trial.
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经腰骶神经调节疗法治疗大便失禁：一项随机频率反应试验。
DOI：
10.14309/ajg.0000000000000766
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发表时间：
2021-01-01
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影响因子：
--
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中科院分区：
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大便失禁（FI）的治疗仍然不令人满意，因为它们不能纠正潜在的多因素功能障碍，包括肛门直肠神经病变。目的：探讨一种旨在改善神经病变的新型治疗方法-经腰骶神经调节疗法（TNT）的最佳剂量频率、临床效果和安全性。FI患者随机接受6次TNT治疗，每周一次，包括在2个腰椎和2个骶骨部位各进行600次重复磁刺激，频率为1 Hz、5 Hz或15 Hz。比较大便日记、FI严重程度指数、肛门直肠神经生理学和感觉运动功能以及生活质量（QOL）。主要结局指标为FI发作/周的变化。应答者为每周FI发作减少≥50%的患者。33例FI患者参与研究。与基线相比，所有三组的FI发作均显著减少（Δ ±95% CI，4.2±2.8（1 Hz）; 2±1.7（5 Hz）; 3.4±2.5（15 Hz）; p<0.02）。与5 Hz（36±18.2%）或15 Hz（55±18.2%）相比，1 Hz组的应答率（91±9.1%）显著更高（p=0.04）; 5和15 Hz之间无差异（p=0.667）。与基线相比，肛门神经病变、挤压压力和直肠容量仅在1 Hz时显著改善（p<0.05），但在其他组中没有改善。1和5 Hz时QOL领域显著改善（p<0.05）。无器械相关严重不良事件。TNT在短期内显著改善FI症状，1 Hz频率总体优于5 Hz和15 Hz。肛门直肠神经病变和生理学均显著改善，证明了机制性改善。TNT是一种有前途的、新型的、安全的、有效的和非侵入性的治疗FI的方法。
Treatments for fecal incontinence (FI) remain unsatisfactory because they do not remedy the underlying multifactorial dysfunction(s) including anorectal neuropathy. Aims: To investigate the optimal dose frequency, clinical effects and safety of a novel treatment, translumbosacral neuromodulation therapy (TNT), aimed at improving neuropathy. FI patients were randomized to receive 6 sessions of weekly TNT treatments consisting of 600 repetitive magnetic stimulations over each of 2 lumbar and 2 sacral sites with either 1 Hz, 5 Hz or 15 Hz frequency. Stool diaries, FI severity indices, anorectal neurophysiology and sensori-motor function and quality of life (QOL) were compared. Primary outcome measure was change in FI episodes/week. Responders were patients with ≥50% decrease in weekly FI episodes. Thirty-three FI patients participated. FI episodes decreased significantly (Δ ±95% CI, 4.2±2.8 (1 Hz); 2±1.7 (5 Hz); 3.4±2.5 (15 Hz); p<0.02) in all three groups when compared to baseline. The 1 Hz group showed a significantly higher (p=0.04) responder rate (91±9.1%) when compared to 5 Hz (36±18.2%) or 15 Hz (55±18.2%); no difference between 5 and 15 Hz (p=0.667). Anal neuropathy, squeeze pressure and rectal capacity improved significantly only in 1 Hz (p<0.05) compared to baseline but not in other groups. QOL domains improved significantly (p<0.05) with 1 and 5 Hz. No device related serious adverse events. TNT significantly improves FI symptoms in the short-term, and the 1 Hz frequency was overall better than 5 Hz and 15 Hz. Both anorectal neuropathy and physiology significantly improved, demonstrating mechanistic improvement. TNT is a promising, novel, safe, efficacious, and non-invasive treatment for FI.
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