Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urina
Transcutaneous Tibial Nerve Stimulation for the Treatment of Bladder Storage Symptoms in People With Multiple Sclerosis: Protocol of a Single-arm Feasibility Study
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Transcutaneous tibial nerve stimulation
What it measured
Main measures
Recruitment rate/ retention rate
6 weeks
FeasibilityAdherence rate
6 weeks
Quality of life (reported by participants)Adverse events
6 weeks
SafetyAcceptability of using TTNS: proportion of participants with MS reporting that TTNS is acceptable
6 weeks
Feasibility
Other measures (4)
International Consultation of Incontinence Questionnaire-Overactive bladder (ICIQ-OAB)
6 weeks
Bladder, bowel and sexual functionKings Health Questionnaire
6 weeks
Bladder, bowel and sexual functionQuality of life (reported by participants)3- day bladder diary
6 weeks
Bladder, bowel and sexual functionPatient Perception of Intensity of Urgency Scale
6 weeks
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Self-reported diagnosis of any type of Multiple Sclerosis * Male or female * Aged ≥18 years old * Ambulatory * At least one bladder storage related symptom (e.g. urinary frequency, urinary urgency, nocturia with or without incontinence).
Exclusion criteria
* People with an indwelling urethral catheter or indwelling suprapubic catheter * Urologic disease including bladder malignancy * Diabetic mellitus * Pregnant women or planning to be pregnant during the study time * Recent pelvic related surgery \<1 year * Pacemaker or other metallic internal devices * Urinary tract infections (UTIs) during recruitment phase.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Neurogenic lower urinary tract dysfunction is common among people with Multiple sclerosis 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 treatment option to manage bladder storage symptoms, however, the potential efficacy of TTNS among people with multiple sclerosis 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. The feasibility and acceptability of TTNS to manage storage bladder symptoms using Transcutaneous Electrical Nerve Stimulation (TENS) needs to be established before proceeding with a definitive randomised trial. This study aims to assess whether TTNS is feasible and acceptable as a treatment for bladder storage symptoms in people with MS
Papers
Results
Al Dandan HB, Galvin R, Robinson K, McClurg D, Coote S. Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis. Pilot Feasibility Stud. 2022 Jul 30;8(1):161. doi: 10.1186/s40814-022-01120-1.Results
Al Dandan HB, Galvin R, Robinson K, McClurg D, Coote S. Transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms in people with multiple sclerosis: Protocol of a single-arm feasibility study. HRB Open Res. 2020 Sep 16;3:66. doi: 10.12688/hrbopenres.13107.1. eCollection 2020.
Loading reviews and guidelines…
History
Started
Oct 2020
Main results due
Mar 2021
Finished
Mar 2021