NOTABLe Form 06 in Neuromodulation for Accidental Bowel Leakage

Supplementary study exit interview form 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.补充研究退出访谈表单数据集 研究概况 本研究为一项多中心随机对照临床试验，研究对象为18岁及以上、经两种一线治疗（监督式盆底肌训练（pelvic muscle training, PMT）和止泻药物治疗）后仍未能获得满意症状控制的难治性意外性大便失禁（accidental bowel leakage, ABL）女性患者。 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方案，以明确PTNS对女性中重度粪便失禁（fecal incontinence, FI）是否具有治疗效果。 研究结果显示，尽管经皮胫神经刺激治疗12周后的症状缓解达到了临床重要性阈值，但与假刺激组并无显著差异。 本研究结果不支持采用现有实施流程的经皮胫神经刺激治疗女性粪便失禁。 本研究的纳入标准为：年龄≥18岁、出现至少3个月难治性意外性大便失禁症状，且经两种一线治疗（监督式盆底肌训练与止泻药物治疗）后未能获得满意症状控制的女性患者。