Efficacité Clinique comparée de la Stimulation transcutanée du Nerf Tibial postérieur unilatérale vs bilatérale Pour Traiter Une hyperactivité vésicale Neurologique Non sévère : Essai Clinique randomisé
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Urinary symptom profile score (USP score)
研究概览
简要总结
This study evaluates the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.
详细描述
Urinary disorders are common in neurological diseases. The prognosis of neurological bladders is twofold. On the one hand, symptoms such as incontinence or retention affect quality of life and comfort. On the other hand, complications such as urinary tract infections or renal failure threaten health and even involve patients' vital prognosis. Several therapies are used to treat these urinary disorders including transcutaneous or percutaneous posterior tibial nerve stimulation (SNTP). SNTP is used in treating symptoms of bladder overactivity. This treatment is most often used unilaterally, but can be used bilaterally.
The aim of this study is to evaluate the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.
50 patients will be included, in two arms by randomization, one arm of 25 patients will be treated by unilateral stimuylation and the other arm of 25 patients will be trated by bilateral stimulation.
They will be evaluate at 3, 6 and 12 months by auto questionnaire and the effectivess of each therapy will be compared.
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
- 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
- •Individuals who received research information
- •Individuals affiliated to a social security scheme
- •Individuals over 18 years of age
- •Individuals with non-serious neurological bladder hyperactivity
排除标准
- 未提供
研究组 & 干预措施
bilateral
25 patients with an overactive bladder
干预措施: urostim bilateral (Procedure)
unilateral
25 patients with an overactive bladder
干预措施: urostim unilateral (Procedure)
结局指标
主要结局
Urinary symptom profile score (USP score)
时间窗: 3 months
auto quastionnaire between 0 and 39 points The higher the score the higher the urinary symptoms
次要结局
- mictional calendar(3 months)
- Patient global impression of improvement (PGI-I)(3 months)