Clinical trial NCT04528784: Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urinary Symptoms in People With Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm feasibility study
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate/ retention rate
timeFrame: 6 weeks
measure: Adherence rate
timeFrame: 6 weeks
measure: Adverse events
timeFrame: 6 weeks
measure: Acceptability of using TTNS: proportion of participants with MS reporting that TTNS is acceptable
timeFrame: 6 weeks
Secondary outcomes:
measure: International Consultation of Incontinence Questionnaire-Overactive bladder (ICIQ-OAB)
timeFrame: 6 weeks
measure: Kings Health Questionnaire
timeFrame: 6 weeks
measure: 3- day bladder diary
timeFrame: 6 weeks
measure: Patient Perception of Intensity of Urgency Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick
state: LK
Study officials:
affiliation: University of Limerick
name: Katie Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.