NOTABLe Form 31 in Neuromodulation for Accidental Bowel Leakage

Dietary screener data
Study Description
This study was a multi-center, randomized clinical trial of women 18 years or older with refractory accidental bowel leakage (ABL) symptoms who had failed to achieve satisfactory symptom control from 2 first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of this study was to compare percutaneous tibial nerve stimulation (PTNS) to a validated sham to determine if PTNS was effective for the treatment of moderate-to-severe fecal incontinence (FI) in women. The study found that although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. The findings of this study did not support the use of PTNS as conducted for the treatment of FI in women. Women ≥ 18 years of age with ≥ 3 months of refractory symptoms of accidental bowel leakage (ABL) who had failed to achieve satisfactory symptom control from two first-line treatments of ABL: supervised pelvic muscle training and constipating medications.

膳食筛查数据
研究概况
本研究为一项多中心随机临床试验，纳入18岁及以上、经两种一线难治性意外性粪便失禁（accidental bowel leakage, ABL）治疗方案后未能获得满意症状控制的女性患者，上述一线治疗方案为监督式盆底肌训练（supervised pelvic muscle training, PMT）与致便秘药物。本研究旨在对比经皮胫神经刺激（percutaneous tibial nerve stimulation, PTNS）与经过验证的假刺激手段，以明确PTNS用于治疗女性中重度粪便失禁（fecal incontinence, FI）是否有效。研究结果显示，尽管PTNS治疗12周后的症状改善达到了临床重要性阈值，但该效果与假刺激组未见显著差异。本研究结论不支持采用现有实施方式的PTNS治疗女性粪便失禁。本研究的纳入标准为：18岁及以上女性，伴有至少3个月的难治性意外性粪便失禁（ABL）症状，且经两种一线ABL治疗——监督式盆底肌训练与致便秘药物——治疗后未能获得满意的症状控制。