Pilot Study: Hand & Foot Neuromodulation for Nocturnal Enuresis in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in Number of Nights Wet Per 2 Weeks
研究概览
简要总结
The investigators believe in order to strengthen the evidence in support of transcutaneous foot stimulation in this population the investigators need to move forward with a randomized comparison study using the TENS device on the hand and foot as a control.
详细描述
Nocturnal enuresis is a common problem in children which can have a dramatic psychological and social impact on quality of life. Neuromodulation by transcutaneous foot stimulation of peripheral tibial nerve branches has been shown to produce a prolonged inhibition of micturition reflex contractions and significantly increase bladder capacity. The investigators primary goal was to evaluate the effect of foot stimulation on the frequency of nocturnal enuresis episodes in children.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ages 5 to 18 years old without any specific neurological disorder or urinary tract infection, clinically diagnosed as having nocturnal enuresis AT LEAST 4 episodes per month by history, nocturnal enuresis is a DSM V diagnosable medical condition
- •Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence
- •Having been assessed for and treated if applicable for behavioral etiologies of nocturnal enuresis - consuming excess fluids or specific bladder irritants
- •Having been assessed for and treated if applicable for constipation
排除标准
- •Children with known neurological disorders which may be contributing to nocturnal enuresis episodes
- •Children found through history to have significant behavioral causes of nocturnal enuresis including consumption of excessive fluids or known bladder irritants
- •Children with chronic constipation who are non-compliant with previous pharmacologic efforts to treat.
- •Children who are not adequately potty trained
- •Children with significant daytime symptoms of overactive bladder including frequency, urgency, and daytime incontinence
- •Children 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
Change in Number of Nights Wet Per 2 Weeks
时间窗: 6 weeks
The subject/parents will be instructed to record a night-time voiding log specifying the change in number of nights wet per 2 weeks. This log is included in the IRB application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during week 3 and 4 of the study the subjects will stimulate either their foot or hand to measure any acute effect on nocturnal enuresis episodes and finally during week 5 and 6 of the study, after stimulation subjects will keep a log to evaluate any post-stimulation residual benefit
Response to Treatment
时间窗: An average of 6 weeks
Total number of participants that responded to treatment after stimulation with Hand or Foor unit.
次要结局
未报告次要终点
研究者
Rajeev Chaudhry
Assistant Professor
University of Pittsburgh