Foot Neuromodulation for Nocturnal Enuresis in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Decrease in Nocturnal Enuresis
研究概览
简要总结
To determine the effects of electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
详细描述
Nocturnal Enuresis is a very common and difficult to treat problem in the pediatric population which can have significant negative impact on a child's quality of life. Apart from medications which can have significant side effects limiting their use, there is a lack of effective and safe treatment options for children with frequent nocturnal enuresis. If foot stimulation prior to bed does indeed improve the frequency of nocturnal enuresis, it may provide a safe and non-invasive therapeutic option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 having nocturnal enuresis AT LEAST 4 episodes per month by history
- •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.
研究组 & 干预措施
Tibial Nerve Stimulation
The subject/parents will be instructed to record a night-time voiding log specifying the number of incontinent episodes per night. This log is included in the Institutional Review Board 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 the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit
干预措施: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS (Device)
结局指标
主要结局
Decrease in Nocturnal Enuresis
时间窗: 6 weeks
To determine if foot stimulation can decrease nocturnal enuresis in children as measured by daily night-time voiding log. The outcome is the number of participants that had a clinical response with improvement of at least 1 wet night reduction during the 6-week stimulation period.
次要结局
- Quality of Life Questionnaire Scores(6 weeks)
研究者
Heidi Stephany
Assistant Professor
University of Pittsburgh