NOTABLe Form 96 in Neuromodulation for Accidental Bowel Leakage

Adverse event 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.

不良事件表单数据（Adverse Event Form Data）
研究概况
本研究为一项多中心随机临床试验，针对18岁及以上、经两种一线意外粪便漏出（Accidental Bowel Leakage, ABL）治疗方案仍未能获得满意症状控制的难治性意外粪便漏出患者，上述两种一线治疗方案分别为监督式盆底肌训练（Pelvic Muscle Training, PMT）与止泻药物。
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疗法，以明确PTNS对女性中重度粪便失禁（Fecal Incontinence, FI）的治疗有效性。
研究结果显示，尽管PTNS治疗12周后的症状降幅达到了具有临床重要性的阈值，但与假刺激组并无显著差异。
本研究结果不支持采用现行实施方案的PTNS用于女性粪便失禁的治疗。
纳入本研究的受试者为年龄≥18岁、患难治性意外粪便漏出症状≥3个月、且经两种ABL一线治疗（监督式盆底肌训练与止泻药物）未能获得满意症状控制的女性患者。