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

NCT04528784 | Completed

• 1 other identifier: TTNS in MS
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Multiple sclerosis; Neurogenic bladder; Feasibility study; Tibial nerve stimulation

Outcome Measures

Primary Outcomes (4)

• 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

• Adherence rate

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

  6 weeks

• Adverse events

  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

  The proportion of participants with MS reporting that TTNS is acceptable.

  6 weeks

Secondary Outcomes (4)

• International Consultation of Incontinence Questionnaire-Overactive bladder (ICIQ-OAB)

  6 weeks

• Kings Health Questionnaire

  6 weeks

• 3- day bladder diary

  6 weeks

• Patient Perception of Intensity of Urgency Scale

  6 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

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 .

Also known as: Stimulation of tibial nerve.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

University of Limerick

Limerick, LK, Ireland

Location

Related Publications (2)

• Al Dandan HB, Galvin R, Robinson K, McClurg D, Coote S. Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis. Pilot Feasibility Stud. 2022 Jul 30;8(1):161. doi: 10.1186/s40814-022-01120-1.

  PMID: 35908067 DERIVED

• Al Dandan HB, Galvin R, Robinson K, McClurg D, Coote S. Transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms in people with multiple sclerosis: Protocol of a single-arm feasibility study. HRB Open Res. 2020 Sep 16;3:66. doi: 10.12688/hrbopenres.13107.1. eCollection 2020.

  PMID: 33117961 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Nocturia; Lower Urinary Tract Symptoms; Multiple Sclerosis; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations

Study Officials

• Katie Robinson, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer, Occupational therapy

Model Details: Single-arm feasibility study

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 27, 2020
• Study Start: October 14, 2020
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

IE (1)