Enuresis Alarm - Is a Manual Trigger System Beneficial?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Evaluate the change and % reduction in mean number wet nights/week (>90%, 50-89%, <50%) of patients with treatment success with use of a manual trigger + moisture alarm vs. moisture alarm only
研究概览
简要总结
The purpose of this study is to evaluate whether the bedwetting alarm trigger activated by parents to wake their child, in addition to the moisture alarm, will improve treatment success compared to the moisture alarm alone.
详细描述
Nocturnal enuresis is a common issue in children, and use of bedwetting alarms has shown the best long-term success. However, use of alarms is very time-intensive, often taking months before yielding results. Researchers in the division of pediatric urology are initiating a randomized controlled study comparing a standard bedwetting alarm with a newly developed technology, with the hope that the new alarm will result in better, more rapid, and easier treatment for bedwetting.
Children between the ages of 5 to 15 years old who have issues with bedwetting after successful toilet training may qualify for the study.
Participants must first be evaluated by a pediatric urology specialist.
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 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children ages 5-15 years
- •Diagnosis of Primary Monosymptomatic Nocturnal Enuresis
- •>2 wet nights per week
- •Score of 7 or below on questions 1-6 and 9-13 on Vancouver Dysfunctional Elimination Questionnaire
- •Patients/parents compliance in recording data > 50% of nights
排除标准
- •Known comorbid conditions: daytime incontinence, anatomic abnormalities (hydronephrosis, VUR), recurrent urinary tract infection, dysuria, neurogenic bladder, developmental delay, encopresis, diabetes insipidus, previous history of urologic surgery
- •Concomitant DDAVP use, anticholinergic use, B3 agonist use
结局指标
主要结局
Evaluate the change and % reduction in mean number wet nights/week (>90%, 50-89%, <50%) of patients with treatment success with use of a manual trigger + moisture alarm vs. moisture alarm only
时间窗: one year
Bladder Diary (Participant self-reported)
次要结局
未报告次要终点
研究者
Gina Lockwood
Principal Investigator, Medical Doctor
University of Iowa