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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04528784
• Other study ID #: TTNS in MS
• Status: Completed
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: March 12, 2021

Study information

• Verified date: April 2021
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 12, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Dysfunction
• Enuresis
• Lower Urinary Tract Symptoms
• Multiple Sclerosis
• Neurogenic Bladder Dysfunction
• Nocturia
• Sclerosis
• Urinary Bladder, Neurogenic
• Urinary Bladder, Overactive
• Urinary Frequency More Than Once at Night
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

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 .

Locations

Country	Name	City	State
Ireland	University of Limerick	Limerick	LK

Sponsors (1)

Lead Sponsor	Collaborator
University of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate/ retention rate	The proportion of participants who are recruited to the study and the proportion of participants who are lost to follow up	6 weeks
Primary	Adherence rate	The proportion of participants who adhere to the treatment protocol of 6 weeks	6 weeks
Primary	Adverse events	Number of participants with adverse events as a measure of safety	6 weeks
Primary	Acceptability of using TTNS: proportion of participants with MS reporting that TTNS is acceptable	The proportion of participants with MS reporting that TTNS is acceptable.	6 weeks
Secondary	International Consultation of Incontinence Questionnaire-Overactive bladder (ICIQ-OAB)	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.	6 weeks
Secondary	Kings Health Questionnaire	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.	6 weeks
Secondary	3- day bladder diary	Number of episodes of frequency, nocturia, and incontinence/ 72 hours will be calculated and compared from baseline with higher values indicating increased symptom severity.	6 weeks
Secondary	Patient Perception of Intensity of Urgency Scale	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.	6 weeks