Minirin Versus Oxybutynin for Nocturnal Enuresis in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- ّFrequency of nocturnal enuresis
研究概览
简要总结
Nocturnal enuresis is among the most common disorders in children. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.
详细描述
Nocturnal enuresis is among the most common disorders in children. Several pharmacological and non-pharmacological treatments are available for nocturnal enuresis. Studies for reaching the best pharmacological treatment for this disorder are continuing. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>5 years old
- •Nocturnal enuresis
- •Candidate for pharmacological treatment
排除标准
- •Children who their parents did noted filled the informed consent form
- •Impossibility of follow up during the study period
- •History of seizure
- •History of rheumatologic disorders such as sjogren's disease
研究组 & 干预措施
Minirin
120 microgram per day for 2 months, then 60 microgram per day for 2 months, then 60 microgram every two days for two months
干预措施: Minirin (Drug)
Oxybutynin
5 mg Oxybutynin twice a daily for 6 months
干预措施: Oxybutynin (Drug)
结局指标
主要结局
ّFrequency of nocturnal enuresis
时间窗: 6 months
Number of participants with nocturnal enuresis
次要结局
- Frequency of urinary incontinency(6 months)
- Frequency of urgency(6 months)
- Frequency of Xerostomia(6 months)
- Frequency of Xerophthalmia(6 months)
- Frequency of Blurred vision(6 months)
- Frequency of Dysphagia(6 months)
- Frequency of constipation(6 months)
- Frequency of Diarrhea(6 months)
- Frequency of Headache(6 months)
- Frequency of Seizure(6 months)
- Frequency of Epistaxis(6 months)
- Frequency of Abdominal pain(6 months)
- Frequency of Vomiting(6 months)
- Frequency of Ear ache(6 months)
- Frequency of Rhinitis(6 months)
- Frequency of Chest pain(6 months)
- Frequency of Increase in appetite(6 months)
研究者
Hamidreza Mahboobi
Principal Investigator
Hormozgan University of Medical Sciences