Efficacy of Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke: A Randomized Placebo-controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Decreased frequency of increased voiding
研究概览
简要总结
The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke.
The main questions aimed to be answered are:
What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients aged 40 and above with stable ischemic or hemorrhagic stroke.
- •Patients with neurogenic detrusor overactivity symptoms accompanied by urinary incontinence complaints and a urinary frequency of 9 or more.
- •Patients diagnosed with detrusor overactivity on urodynamic evaluation.
- •Patients with hemiplegia lasting between 30 days and 1 year.
- •Ability to understand procedures, benefits, and potential side effects.
- •Patients scoring 22 or above on the Mini Mental Test.
排除标准
- •Patients with post-stroke neurogenic detrusor overactivity receiving or previously received pharmacological treatment.
- •Patients using intermittent catheterization or permanent catheterization as a bladder emptying method.
- •Patients with a history of urinary incontinence and/or urinary retention before stroke.
- •History of past urogynecological surgery.
- •Presence of urinary tract infection, bladder tumor, or cardiac pacemaker.
- •Significant fluid infusion requirement affecting urination or use of medication affecting bladder function.
- •Patients who have received botulinum toxin injection for post-stroke neurogenic detrusor overactivity.
- •Patients with postvoid residual volume above 150 mL.
结局指标
主要结局
Decreased frequency of increased voiding
时间窗: Change from baseline positive response rate at the 4th week after the treatment
The effectiveness of the treatment is evaluated based on the daily voiding frequency post-treatment compared to the daily voiding frequency pre-treatment. The expected outcome is a reduction in the frequency of increased voiding.
次要结局
- Frequency of voiding(Change from baseline Frequency of voiding, nocturia, number of pads at the 4th week after the treatment)
- The Quality of Life(Change from baseline the Quality of Life at the 4th week after the treatment)
- Barthel Index for Activities of Daily Living (ADL)(Change from baseline Barthel Index for Activities of Daily Living at the 4th week after the treatment)
- The Overactive Bladder Symptom Score (OABSS)(Change from baseline The Overactive Bladder Symptom Score at the 4th week after the treatment)
- Treatment Satisfaction Level(Change from baseline Treatment Satisfaction Level at the 4th week after the treatment)
- Cystometric value(Change from baseline Cystometric value at the 4th week after the treatment)
研究者
Necmettin Yildiz
Professor Doctor
Pamukkale University