Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis. A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The children will be non-responders, partial responders, or full responders to therapy
研究概览
简要总结
To determine whether there is a role for the selective serotonin reuptake inhibitors fluoxetine versus desmopressin in the treatment of nocturnal enuresis in children who have not responded to standard nonpharmacological urotherapy, and whether there are side effects involved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 7 years
- •Severe enuresis with at least (50%) seven wet nights out of 14
- •Failed treatment
- •The enuresis alarm was either ineffective or considered impractical due to the family circumstances.
排除标准
- •Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions
- •Patients with psychiatric disorders and behavioral disorders including depression, attention-deficit/hyperactivity disorder.
- •Untreated constipation
- •Contraindications to fluoxetine or desmopressin treatment
研究组 & 干预措施
fluoxetine
selective serotonin reuptake inhibitors fluoxetine 20 mg for 12 weeks
干预措施: Fluoxetine 20 MG (Drug)
desmopressin
0.2 mg desmopressin tablet for 12 weeks
干预措施: Desmopressin (Drug)
结局指标
主要结局
The children will be non-responders, partial responders, or full responders to therapy
时间窗: three months
The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society "ICCS definitions" (i.e., if the reduction of enuresis frequency was below or above 50% or 90%, respectively)
次要结局
未报告次要终点
研究者
Hesham Abdel Azim El Helaly
Assistant Professor
Fayoum University Hospital