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

Diseases of the Colon and Rectum
Craig J RimmerKathryn A Gill

Abstract

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. 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. This was a randomized, investigator-blinded, parallel-arm, 6-week pilot trial. 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. A total of 43 eligible patients (38 women) who failed conservative management of fecal incontinence were included in the study. The study intervention involved twice-weekly, 1- versus 4-hour transcutaneous tibial nerve stimulation for 6 weeks (total of 12 treatments). 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. A total of 22 patients were randomly assigned to the 1-hou...Continue Reading

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Citations

May 10, 2016·World Journal of Gastrointestinal Pharmacology and Therapeutics·Klaus Bielefeldt
Sep 1, 2018·Revista Española De Enfermedades Digestivas : Organo Oficial De La Sociedad Española De Patología Digestiva·Rubén Arroyo FernándezAsunción Ferri Morales
Jul 18, 2020·United European Gastroenterology Journal·Ferdinando D'AmicoLaurent Peyrin-Biroulet
Jan 8, 2021·Colorectal Disease : the Official Journal of the Association of Coloproctology of Great Britain and Ireland·Peter ChristensenUNKNOWN MANUEL Project Working Group

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