Effect of Transcutaneous Posterior Tibial Nerve Stimulation and Parasacral Transcutaneous Electrical Stimulation on Neurogenic Overactive Bladder Symptoms in Female Patients With Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Uroflowmetry
研究概览
简要总结
This study aims to evaluate the use of transcutaneous tibial nerve stimulation (TTNS) and parasacral nerve stimulation (PSS) methods in the treatment of overactive bladder (OAB) symptoms in patients with Multiple Sclerosis (MS), including urination frequency, urgency, urinary incontinence, post-void residue, maximum micturition rate. To investigate the effect on parameters such as voiding volume and quality of life and to compare the final results between groups.
详细描述
Participants will be divided into 3 groups: TTNS, PNS, and placebo groups, and all participants will be given behavioral treatment. Tibial nerve stimulation will be given to the TTNS group, sacral nerve stimulation will be given to the PNS group, and sham current will be given to the placebo group. Stimulation treatments will be applied 2 days a week for 30 minutes each for 6 weeks. Participants will be evaluated before and after treatment. The parameters of urination frequency, urgency, and urinary incontinence will be evaluated with a 3-day voiding diary (BD), maximum flow rate (Qmax), time to reach maximum flow (TQmax), average flow rate, flow time (Tw), voiding time and voiding volume (VV) values will be evaluated by uroflowmetry, post-voiding residual (PVR) volume will be evaluated by ultrasound, and quality of life will be evaluated by King's Quality of Life Questionnaire (KHQ); Expanded Disability Status Scale (EDSS), Overactive bladder form (OAB-v8), Incontinence Severity Index (ISI), Neurogenic Bladder Symptom Score (NBSS) will be recorded.
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 (Outcomes Assessor)
盲法说明
The statistician will be blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having symptoms related to overactive bladder (OAB-v8 score ⩾8),
- •Over 18 years of age
- •No relapse for at least 1 month
- •All types of MS, including those with relapses
- •Female MS patients with an Expanded Disability Status Scale (EDSS) score below 7.0
- •Agreeing to participate in the research
排除标准
- •Patients with urinary tract infections
- •Patients diagnosed with diabetes mellitus
- •Patients using diuretic drugs or patients with a clean intermittent catheter
- •Patients with a history of different urological diseases
- •Patients with heart or brain pacemaker users, those with epilepsy, and patients with language and cognitive limitations
- •Patients who are pregnant or in the postpartum period
- •Lack of activity performance for 2 weeks (regardless of which group)
结局指标
主要结局
Uroflowmetry
时间窗: After the 6-week intervention
It provides a valuable non-invasive assessment of voiding functions. It is the measurement of urine flow rate in ml/sec with the help of a flow meter. Since it is non-invasive among urodynamic tests, it can be used for screening purposes. Pattern and rate of flow depend on detrusor function and bladder outlet resistance.
Post voiding residue (PVR)
时间窗: After the 6-week intervention
PVR will be measured using a 5-13-MHz convex ultrasound probe.
次要结局
- Overactive bladder form (OAB-v8)(After the 6-week intervention)
- Neurogenic Bladder Symptom Score (NBSS)(After the 6-week intervention)
- King's Quality of Life Questionnaire (KHQ)(After the 6-week intervention)
- Incontinence Severity Index (ISI)(After the 6-week intervention)
- Three-day bladder diary (BD)(After the 6-week intervention)
研究者
Busra Aydin Erkilic
Physiotherapist
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization