Randomized Study Of Novel Enuresis Alarm (GoGoband® )Vs Standard Nocturnal Enuresis Alarm (SNEA)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Wet Nights
研究概览
简要总结
Identify the dry night rate in patients using the GoGoband® nocturnal enuresis device vs a standard Pflaundler bedwetting alarm.
详细描述
3.1 Problem Statement At the present time, there are no side-by-side comparison studies of GoGoband® vs SNEA. Since many of the prior studies were conducted using variable outcome parameters that makes direct comparisons of studies difficult it would be beneficial to obtain comparable data from the 2 groups and compare dry night rates for the 2 devices.
3.2 Purpose of Study/Potential Impact Our preliminary quality improvement data indicates that the GoGoband® is more efficacious than both medication and SNEA in an uncontrolled environment when deidentified data was analyzed off our servers. Our present database does not allow us to discern if patients are monosymptomatic nocturnal enuresis (MNE) or non monosymptomatic nocturnal enuresis (NMNE). Without this ability as well as for controlling for behavioral and academic problems which are known to affect outcomes in nocturnal enuresis studies, the investigators are not able to compare our results definitively and accurately to other treatment modalities.
Hypothesis Our hypothesis is that the GoGoband® is more effective than SNEA and Desmopressin in the treatment of Nocturnal Enuresis Primary Objective The primary objective of this study is to determine whether the GoGoband®] is as effective or more effective in comparison to children who use SNEA in a population of MNE patients with no underlying Attention deficit hyperactivity disorder (ADHD) in a 3 month period.
Secondary Objectives
To ascertain if familial incidence of nocturnal enuresis has an effect on outcomes
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
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 6 to 21 years
- •In good general health as evidenced by medical history and diagnosed with MNE
- •Ability to and be willing to adhere to the treatment regimen. -
排除标准
- •No patient may have had treatment of MNE in the past 6 months whether with medications or alarms
- •Current use of on ADHD medications, Tricyclics, SSRI's, NRI's or any antipsychotic medications.
- •Presence of Autistic Spectrum disorder, ADHD, genetic syndrome associated with developmental or learning disabilities
- •Treatment with another investigational drug or other intervention within last 6 months
- •Any form of Diabetes Mellitus or Diabetes Insipidus
- •No patient with known Chronic renal disease with moderate to severe renal impairment (defined as a creatinine clearance below 50mL/min).
- •No patient with known hyponatremia or a history of hyponatremia.
研究组 & 干预措施
gogoband alarm
patients will be assigned to the novel bedwetting alarm
干预措施: gogoband (Device)
standard nocturnal enuresis alarm (SNEA) group
this is the standard bedwetting alarm that is presently available through out the world
干预措施: SNEA group (Device)
结局指标
主要结局
Number of Wet Nights
时间窗: 3 month period
Comparison of alarms are to determine whether the GoGoband®\] is as effective or more effective in comparison to children who use SNEA in a population of MNE patients with no underlying ADHD. The number of wet nights in each group will be compared to each other providing a comparison of the data. The data will be compared using either a T test or Kruskal Wallis or anova depending on the number of comparisons performed and the data distribution is normal or not. If patient numbers are less than 10 per group no statistical analysis will be performed.
次要结局
未报告次要终点