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

University of Limerick

Status: Completed

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

Treatments: Device: Transcutaneous tibial nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04528784

TTNS in MS

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

23 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous tibial nerve stimulation