Outcome of Treatment of Monosymptomatic Nocturnal Enuresis in Children Using Imipramine Alone Versus Sulbutiamine Alone Versus Imipramine Plus Sulbutiamine : Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- reduction in the number of wet nights .
研究概览
简要总结
The aim of the study is to evaluate the role of sulbutiamine in treatment of monosymptomatic nocturnal enuresis in children by using it alone or as a combination therapy with tricyclic antidepressants (imipramine+sulbutiamine).
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age : 6 - 18 years old.
- •All children diagnosed by Primary monosymptomatic nocturnal enuresis in this age group.
排除标准
- •Secondary nocturnal enuresis (child who has been continent for at least 6 months before the onset of bedwetting ).
- •congenital anomalies (Posterior urethral valve , ectopic ureter , ectopia vesica ,...)
- •history of previous lower urinary tract surgery (Multiple hypospadias surgeries ,..., )
- •neurogenic bladder (as underactive bladder ).and urge incontinence.
- •presence of post-void residual urine greater than 20% of functional bladder capacity.
- •history or evidence of disorders in other organs such as (cardiovascular system disease), liver , psychological problems , evident allergic reaction to both medication.
研究组 & 干预措施
group A
this group will receive imipramine alone
干预措施: Imipramine (Drug)
group B
this group will receive sulbutiamine alone
干预措施: Sulbutiamine (Drug)
group C
this group will receive sulbutiamine plus imipramine
干预措施: Sulbutiamine (Drug)
group C
this group will receive sulbutiamine plus imipramine
干预措施: Imipramine (Drug)
结局指标
主要结局
reduction in the number of wet nights .
时间窗: the number of wet nights will be measured and compared at the end of each month for 3 months using a calendar fulfilled by the child and his parents.
A questionnaire which measure the Response to treatment which will be evaluated by the standardization committee of International clildren's continence society (ICCS) as follows : * Complete response : 100% reduction * Partial response : 50% - 99% reduction * Unresponsiveness : 0 - 49% reduction in nocturnal enuresis episodes. this will be measured by a questionnaire that will be written according a calendar fulfilled by the child and his parents with comparison of the number of wet nights each month.
次要结局
- determine any side effects of the drugs used in the study(this will be discussed in the follow up that will be done in each month in the outpatient clinic for 3 months.)
研究者
Loai Mohammed Abd Al-Hamied
resident of urology , sohag university hospital
Sohag University