Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urinary Symptoms in People With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Bladder Dysfunction; Urinary Bladder, Overactive; Neurogenic Bladder Dysfunction; Urinary Incontinence; Urinary Bladder, Neurogenic; Multiple Sclerosis; Urinary Incontinence, Urge; Nocturia; Lower Urinary Tract Symptoms; Urinary Frequency More Than Once at Night
• Interventions: Device: Transcutaneous tibial nerve stimulation

• Registration Number: NCT04528784
• Lead Sponsor: University of Limerick

Brief Summary

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

Detailed Description

The investigators will use a single-arm experimental study to explore the feasibility and acceptability of TTNS in the treatment of bladder storage symptoms in multiple sclerosis. 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 study. The investigators will assess recruitment/retention rates, the urinary symptoms changes and the effect on quality of life using International classification of incontinence questionnaire - overactive bladder (ICIQ-OAB), 3-day bladder diary, King's Health Questionnaire and collect self-reported data on adherence and adverse events and acceptability of using TTNS.

Study Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-27
• Study Start: 2020-10-14
• Primary Completion: 2021-03-12
• Study Completion: 2021-03-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Transcutaneous tibial nerve stimulation	Transcutaneous tibial nerve stimulation will be applied as follows: 18 sessions of 30 minutes duration, delivered three times a week over a 6 week period using TENS device with 10 Hertz (Hz), and pulse width 200µs. The intensity of stimulation will be at the sensory and motor threshold by tingling sensation on sole of the foot with flexion of big toe and /or fanning of other toes.

Primary Outcome Measures

Name	Time	Method
Adverse events	6 weeks	Number of participants with adverse events as a measure of safety
Acceptability of using TTNS: proportion of participants with MS reporting that TTNS is acceptable	6 weeks	The proportion of participants with MS reporting that TTNS is acceptable.
Recruitment rate/ retention rate	6 weeks	The proportion of participants who are recruited to the study and the proportion of participants who are lost to follow up
Adherence rate	6 weeks	The proportion of participants who adhere to the treatment protocol of 6 weeks

Secondary Outcome Measures

Name	Time	Method
Kings Health Questionnaire	6 weeks	Changes in scores for the effect of urinary symptoms in activity of daily living measured by the Kings Health Questionnaire. Each domain within the Kings Health Questionnaire is scored on a 0 (best) to 100 (worst) scale. A change from baseline of 5 points or higher on most of the King's Health Questionnaire domains represents a clinically meaningful improvement in health-related quality of life after treatment.
3- day bladder diary	6 weeks	Number of episodes of frequency, nocturia, and incontinence/ 72 hours will be calculated and compared from baseline with higher values indicating increased symptom severity.
International Consultation of Incontinence Questionnaire-Overactive bladder (ICIQ-OAB)	6 weeks	Changes in the severity of scores for bladder storage symptoms experienced by participants measured using ICIQ-OAB. It has grade A for validity, reliability and responsiveness to change established with rigour on one data set. The total score ranges from 0 to 16 with higher values indicating increased symptom severity. Bother scales are not incorporated in the overall score.
Patient Perception of Intensity of Urgency Scale	6 weeks	Number of urgency episodes and severity of urgency/72 hours will be calculated and compared from baseline. The total score ranges from 0 to 4 with higher values indicating increased symptom severity.

Trial Locations

Locations (1)

University of Limerick; 🇮🇪 Limerick, LK, Ireland