Transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms in people with multiple sclerosis: Protocol of a single-arm feasibility study

Background: Neurogenic lower urinary tract dysfunction (NLUTD) is common among people with multiple sclerosis (MS) with a pooled prevalence of 68.41% using self-report measures and 63.95% using urodynamic studies. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive option to manage bladder storage symptoms; however, the potential efficacy of TTNS among people with MS is based on a small number of studies with the absence of high-quality evidence relating to efficacy, and lack of clarity of the optimal electrical stimulation parameters and frequency, duration and number of treatment sessions. This study aims to assess whether TTNS is feasible and acceptable as a treatment for bladder storage symptoms in people with MS. Methods: We will use a single-arm experimental study to explore the feasibility and acceptability of TTNS in the treatment of bladder storage symptoms in MS. The CONSORT extension for pilot and feasibility studies will be followed to standardise the conduct and reporting of the study. The recruitment plan is twofold: 1) Open recruitment for people with MS through MS Ireland’s communication channels; 2) recruitment from a convenience sample of people with MS who have previously participated in a qualitative interview study of urinary symptoms. We will assess recruitment/retention rates, the urinary symptoms changes and the effect on quality of life pre and post intervention using ICIQ-OAB, 3-day bladder diary, King’s Health Questionnaire and collect self-reported data on adherence and adverse events. Acceptability of using TTNS will be evaluated at the end of intervention. This study has been reviewed and approved by the Education and Health Science’s Faculty Research Ethics Committee, University of Limerick [2020_06_07_EHS]. Conclusion: It is anticipated that assessing the feasibility and acceptability of TTNS for storage bladder symptoms in MS will inform the development of a definitive randomised trial. Trial registration: ClinicalTrials.gov NCT04528784 27/08/2020