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

Dis Colon Rectum. 2015 Oct;58(10):974-82. doi: 10.1097/DCR.0000000000000444.

Abstract

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anal Canal / physiopathology*
  • Fecal Incontinence* / physiopathology
  • Fecal Incontinence* / psychology
  • Fecal Incontinence* / therapy
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Quality of Life*
  • Recovery of Function
  • Recurrence
  • Symptom Assessment / methods
  • Tibial Nerve*
  • Time Factors
  • Transcutaneous Electric Nerve Stimulation / methods*
  • Treatment Outcome
  • United Kingdom