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

April 27, 2021 updated by: Katie Robinson, University of Limerick

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • LK
      • Limerick, LK, Ireland
        • University of Limerick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Consultation of Incontinence Questionnaire-Overactive bladder (ICIQ-OAB)
Time Frame: 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.
6 weeks
Kings Health Questionnaire
Time Frame: 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.
6 weeks
3- day bladder diary
Time Frame: 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.
6 weeks
Patient Perception of Intensity of Urgency Scale
Time Frame: 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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Limerick

Investigators

  • Principal Investigator: Katie Robinson, PhD, University of Limerick

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2020

Primary Completion (Actual)

March 12, 2021

Study Completion (Actual)

March 12, 2021

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTNS in MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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