NOTABLe Form 03 in Neuromodulation for Accidental Bowel Leakage

Run-in bowel diary abstraction 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.