Effectiveness of Transcutaneous Posterior Tibial Nerve Stimulation in Multiple Sclerosis Patients With Lower Urinary Track Symptoms: A Sham Controlled Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Incontinence Quality of Life (I-QOL)
研究概览
简要总结
Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.
Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS.
详细描述
This is a single-centered, prospective, single blind, randomized controlled study of patients with MS who suffer lower urinary track symptoms. All patients will be informed of the details of all the procedures and of the details of the study. After the written informed consent is obtained, patients will be distributed to two equal groups using randomized number table.
At the beginning and end of the study, post-void residue (PVR) will be calculated with ultrasonography, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Quality of Life( I-QOL), 3 day bladder diary (number of urination, urge, incontinence, nocturia) forms will be administered.
Patients will be evaluated via PVR, urodynamic measurements, ICIQ-SF, I-QOL and bladder diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer Adults (Age 18-50)
- •Diagnosis of Multiple Sclerosis
- •Expanded Disability Status Scale (EDSS) 0-6,5
- •Lower urinary track symptoms (Urinary incontinence, urgency, nocturia and/or urinary frequency)
- •Diagnosis of bladder disfunction with Urodynamic study within 1 months
排除标准
- •Age less then 18
- •Pacemaker or implantable defibrillator usage
- •Diabetic polyuria
- •Bleeding diathesis or severe bleeding tendency
- •Pelvic floor disfunction or nerve damage effecting tibial nerve
- •Currently pregnant or planning pregnancy
- •Active urinary infection
- •Active malignancy
- •Severe mental disability
- •Cognitive deficit
- •Expanded Disability Status Scale (EDSS) greater than or equal to 7
- •Unable to attend to TPTNS treatment 2 times a week
- •Urodynamic findings of bladder outlet obstruction
- •Surgical history because of urinary incontinence
- •Urologic surgical history because of lower urinary track disfunction or symptoms
- •Diagnosis of prostatic enlargement
- •Diagnosis of pelvic organ prolapse
结局指标
主要结局
Incontinence Quality of Life (I-QOL)
时间窗: 6 weeks (Before and after the treatment)
I-QOL is used for evaluation of quality of life in patients with incontinence. It comprises 22 questions presented under three subscales: limiting behavior, psychosocial impact, and social embarrassment. All the questions are based on a five-point Likert scale (1 = a lot, 2 = quite a bit, 3 = moderate, 4 = a little, and 5 = not at all). Points obtained by each question are added together which results in a total point of 0 to 110. This total point is then recalculated to take a value between 0-100 for better understand. Higher scores indicate a better quality of life. Validation of turkish version is available.
次要结局
- Bladder diary(6 weeks (Before and after the treatment))
- Post-void residue (PVR)(6 weeks (Before and after the treatment))
- International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)(6 weeks (Before and after the treatment))
研究者
Sibel Caglar Okur
Principal Investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital