Transcutaneous Tibial Nerve Stimulation for the Treatment of Bladder Storage Symptoms in People With Multiple Sclerosis: Protocol of a Single-arm Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Acceptability of using TTNS: proportion of participants with MS reporting that TTNS is acceptable
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Acceptability of using TTNS: proportion of participants with MS reporting that TTNS is acceptable
时间窗: 6 weeks
The proportion of participants with MS reporting that TTNS is acceptable.
Recruitment rate/ retention rate
时间窗: 6 weeks
The proportion of participants who are recruited to the study and the proportion of participants who are lost to follow up
Adherence rate
时间窗: 6 weeks
The proportion of participants who adhere to the treatment protocol of 6 weeks
Adverse events
时间窗: 6 weeks
Number of participants with adverse events as a measure of safety
次要结局
- Kings Health Questionnaire(6 weeks)
- 3- day bladder diary(6 weeks)
- International Consultation of Incontinence Questionnaire-Overactive bladder (ICIQ-OAB)(6 weeks)
- Patient Perception of Intensity of Urgency Scale(6 weeks)
研究者
Katie Robinson
Senior lecturer, Occupational therapy
University of Limerick