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Short-term Outcomes of a Randomized Pilot Trial of 2 Treatment Regimens of Transcutaneous Tibial Nerve Stimulation
Craig J Rimmer1, Charles H Knowles, Michael Lamparelli
11 Faecal Incontinence and Constipation Healthcare Unit, Sandwell and West Birmingham Hospitals National Health Service Trust, West Bromwich, United Kingdom 2 Barts Health National Health Service Trust and National Centre for Bowel Research and Surgical Innovation, Centre for Digestive Diseases, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University London and Barts Health National Health Service Trust, London, United Kingdom 3 Dorset County Hospital National Health Service Foundation Trust, Dorchester, United Kingdom 4 Bristol Royal Infirmary, University Hospitals Bristol National Health Service Foundation Trust, Bristol, United Kingdom 5 Churchill Hospital, Oxford University Hospitals National Health Service Trust, Oxford, United Kingdom 6 Musgrove Park Hospital, Somerset, United Kingdom 7 University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.
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.
