Foot Neuromodulation for Overactive Bladder in Children
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of participants with decreased urinary frequency
研究概览
简要总结
To determine the effects of electrical stimulation of the nerves in the foot on overactive bladder conditions in children.
详细描述
Bladder overactivity in the pediatric population presents a more challenging clinical situation than in adults after failure of medical therapy, as other treatments with proven efficacy such as botulinum injections and interstim sacral nerve stimulators are too invasive for the routine use in children. A non-invasive, effective way to improve overactive bladder in this population would have a great impact on a child's quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ages 5 to 16 years old without any specific neurological disorder or urinary tract infection, clinically diagnosed as idiopathic over active bladder (OAB)
- •Currently having OAB symptoms, i.e. urinary frequency, urgency, or incontinence
- •Having been assessed for and treated if applicable for behavioral etiologies of OAB - holding urine too long, consuming excess caffeine or other bladder irritants.
- •Having been assessed for and treated if applicable for constipation
排除标准
- •Patients with known neurological disorders which may be contributing to OAB symptoms
- •Patients found through history to have significant behavioral causes of OAB including consumption of known bladder irritants and dysfunctional voiding.
- •Patients with chronic constipation who are non-compliant with previous pharmacologic efforts to treat.
- •Patients who are not adequately potty trained
- •Patients who do not tolerate initial stimulation training session in the urology clinic upon enrollment
- •Children with any implantable medical devices such as a pacemaker will be excluded from the study
- •Note: Any patient currently taking medication such as an anti-muscarinic or a tricyclic antidepressant for overactive bladder at time of enrollment will be eligible to participate and will be continued on their usual medication and dosage throughout the study.
结局指标
主要结局
Number of participants with decreased urinary frequency
时间窗: 3 weeks
Foot stimulation decreases urinary frequency measured by a daily voiding diary.
次要结局
- Number of participants with improved over active bladder symptoms(3 weeks)
研究者
Rajeev Chaudhry
Assistant Professor
University of Pittsburgh