Short-term Outcomes of a Randomized Pilot Trial of 2 Treatment Regimens of Transcutaneous Tibial Nerve Stimulation for Fecal Incontinence

BACKGROUND: Fecal incontinence is a socially disabling condition that affects ≤15% of adults. Neuromodulatory treatments for fecal incontinence are now well established. Less invasive, cheaper, and more ambulatory forms of neuromodulation are under exploration. OBJECTIVE: The purpose of this study was to assess the acceptability and safety of a new ambulatory tibial nerve stimulation device and to determine clinical effect size for 2 differing regimens of therapy. DESIGN: This was a randomized, investigator-blinded, parallel-arm, 6-week pilot trial. SETTINGS: The study was conducted at 7 United Kingdom trial centers. Patients were initially reviewed in the trial center, with subsequent applications of the device performed in the patients home setting. PATIENTS: A total of 43 eligible patients (38 women) who failed conservative management of fecal incontinence were included in the study. INTERVENTION: The study intervention involved twice-weekly, 1- versus 4-hour transcutaneous tibial nerve stimulation for 6 weeks (total of 12 treatments). MAIN OUTCOME MEASURES: Standard fecal incontinence outcome tools (bowel diary, symptom severity score, and generic quality-of-life instruments) were used to collect data at baseline and at 2 weeks posttreatment cessation. RESULTS: A total of 22 patients were randomly assigned to the 1-hour group and 21 to the 4-hour group. Improvements in fecal incontinence outcomes were observed for both groups, including median urge incontinence episodes per week at baseline and posttreatment (1-hour group 2.0 to 0.5 versus 4-hour group 4.0 to 1.0) and deferment time (1-hour group 2.0 to 2.0 minutes versus 4-hour group 0.5 to 5.0 minutes). Accompanying changes were observed in physical functioning domains of quality-of-life instruments. There were no adverse events, and the treatment was highly acceptable to patients. LIMITATIONS: Limitations included the pilot design and lack of control arm in the study. Future trials would need to address these limitations. CONCLUSIONS: This pilot study provides evidence that transcutaneous tibial nerve stimulation with a new ambulatory device is safe and acceptable for the management of fecal incontinence. Additional study is warranted to investigate clinical effectiveness.