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Completed

NCT Number: NCT04528784

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

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

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Key information

Conditions

Bladder Dysfunction Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Multiple Sclerosis Nervous System Diseases Neurogenic Bladder Dysfunction Neurologic Manifestations Nocturia Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Bladder, Overactive Urinary Frequency More Than Once at Night Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Limerick

Limerick, LK, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous Tibial Nerve Stimulation

Device

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.

Primary outcomes

  1. 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

  2. Adherence rate

    Time frame: 6 weeks

    The proportion of participants who adhere to the treatment protocol of 6 weeks

  3. Adverse events

    Time frame: 6 weeks

    Number of participants with adverse events as a measure of safety

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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