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

Sponsor

University of Limerick (Other)

Overall Status

Completed

CT.gov ID

NCT04528784

Collaborator

(none)

Enrollment

Location

Arm

4.9

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Bladder Dysfunction Neurogenic Bladder Dysfunction Urinary Incontinence Urinary Bladder, Overactive Urinary Incontinence, Urge Nocturia Urinary Frequency More Than Once at Night Lower Urinary Tract Symptoms Multiple Sclerosis Urinary Bladder, Neurogenic	Device: Transcutaneous tibial nerve stimulation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single-arm feasibility studySingle-arm feasibility study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Transcutaneous Tibial Nerve Stimulation for the Treatment of Bladder Storage Symptoms in People With Multiple Sclerosis: Protocol of a Single-arm Feasibility Study

Actual Study Start Date :

Oct 14, 2020

Actual Primary Completion Date :

Mar 12, 2021

Actual Study Completion Date :

Mar 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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.	Device: Transcutaneous tibial nerve stimulation Transcutaneous tibial nerve stimulation is a non-invasive electrical stimulation of the posterior tibial nerve, a branch of the sciatic nerve via sacral plexus. In our study the tibial nerve will be stimulated using Transcutaneous Electrical Nerve Stimulation (TENS) unit with two surface adhesive electrodes. The anode will be positioned between 5-10 cm above medial malleolus and posterior to the edge of the tibia and the cathode will be positioned distally on arch of the foot . Other Names: Stimulation of tibial nerve.

Arm

Intervention/Treatment

Experimental: Intervention

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.

Device: Transcutaneous tibial nerve stimulation

Transcutaneous tibial nerve stimulation is a non-invasive electrical stimulation of the posterior tibial nerve, a branch of the sciatic nerve via sacral plexus. In our study the tibial nerve will be stimulated using Transcutaneous Electrical Nerve Stimulation (TENS) unit with two surface adhesive electrodes. The anode will be positioned between 5-10 cm above medial malleolus and posterior to the edge of the tibia and the cathode will be positioned distally on arch of the foot .

Other Names:

Stimulation of tibial nerve.

Outcome Measures

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).