Perineal Rehabilitation: Efficacy of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Measure of variation of urinary urgency
研究概览
简要总结
Recently, several studies have investigated the safety and efficacy of the Stoller afferent nerve stimulation (SANS) treatment in Multiple Sclerosis (MS) patients. However, because of the differences among the published protocols (percutaneous versus transcutaneous stimulation, stimulation site, total number of sessions), and the absence of data on the duration of the effect, this treatment is not yet currently included in the rehabilitation programs. The present study aims at evaluating the efficacy of a protocol of SANS in the short- and medium-term follow-up.
The efficacy of the proposed stimulation protocol on the physiological parameters of bladder function will be also investigated.
详细描述
The primary outcome will be the variation of urinary urgency and incontinence. It will be evaluated by self-reported measuring scales, such as the Overactive Bladder Questionnaire (OAB-q) and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) in their Italian forms.
The expected outcome is that the treatment of posterior tibial nerve stimulation will reduce the frequency and the urgency of urination, and urinary incontinence. Moreover, results from the follow-up will allow estimating the duration of the expected outcome.
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
- •MS diagnosis according to the revised McDonalds criteria. Relapsing-remitting, primary and secondary progressive MS forms are allowed;
- •Expanded Disability Status Scale (EDSS) between 2 and 6.5 included;
- •MiniMental State Examination ≥ cut off 24/84 by sex/age
- •Exclusion criteria:
- •Any of the following in the month before enrolment: an MS relapse; current corticosteroids therapy because of MS; change in medicines prescribed against fatigue; attending an intensive physical therapy program;
- •New or active lesions on a brain or spinal cord MRI scan in the 12 months before the study enrolment;
- •Any musculoskeletal disease or any additional neurological disorder
- •Urinary infections or surgery in perineal regions
- •Skin lesions or carcinoma in situ
- •Pregnancy
- •Expanded Disability Status Scale (EDSS) ≥ 7;
排除标准
- 未提供
研究组 & 干预措施
Patients with Multiple Sclerosis
Patients with Multiple Sclerosis
干预措施: Stoller's Afferent Nerve Stimulation (SANS) (Other)
结局指标
主要结局
Measure of variation of urinary urgency
时间窗: Baseline, at 3 weeks after the start of SANS, at 2 months after the end of SANS
Evaluated by the Overactive Bladder Questionnaire (OAB-q) in the Italian language.
Measure of variation of incontinence.
时间窗: Baseline, at 3 weeks after the start of SANS, at 2 months after the end of SANS
Evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) in the Italian language.
次要结局
未报告次要终点