Prospective, Randomized, Controlled, Multicenter Clinical Trial of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Classification accuracy
研究概览
简要总结
Nocturnal enuresis is common problem in children who are from 5 to 18 years old and do not spontaneously urinate at least 2 times a week for more than 3 months. It can lead to major distress for the children and their parents. The investigators hypothesize that the 3-day voiding diary as the same as the 7-day voiding diary could be a diagnostic tool to provide information on the diagnosis and classification of nocturnal enuresis. The purpose of this study is to investigate the reliability and sensitivity of 3-day versus 7-day voiding diary to diagnose nocturnal enuresis.
详细描述
During the first visit to a doctor, a questionnaire about nocturnal enuresis will be filled in and additional tests will be done according to the standard procedure to screen out who have monosymptomatic enuresis.Then participants will complete a 3-day voiding diary or a 7-day voiding diary before treatment. During the second visit to a doctor, doctors will diagnose by voiding diary which type of enuresis is present. Participants need to fill in the 3-day or 7-day voiding diary at 1, 3 and 6 months after standard treatment. About 800 patients from 5 to 18 years old will be included in this prospective, randomized, controlled, multi-center and large sample study and will be followed up at the outpatient clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
According to cluster randomization, several centers use the 3-day voiding diary and the other centers use the 7-day voiding diary. Participants will be randomly assigned and don't know they are in which cluster.
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children are from 5 to 18 years old and do not spontaneously urinate at least 2 times a week for more than 3 months.
- •Monosymptomatic Enuresis (MNE): children are only associated with nocturnal enuresis, not with daytime lower urinary tract symptoms.
排除标准
- •Non-Monosymptomatic Enuresis (NMNE):children have day-time symptoms, such as overactive bladder, discoordinated micturition, dysuria, infrequent voiding and so on.
- •Children have psychiatric disorder, urinary tract infection, malformations of the urethra, kidney disease and so on.
- •3.Children have been previously treated for nocturnal enuresis who use drugs or other therapeutic regimen.
- •4.Secondary enuresis: after 6 months of non-enuresis period, children wet the bed again.
结局指标
主要结局
Classification accuracy
时间窗: 1 week
According to the results of urinating diary, the subtype of primary nocturnal enuresis would be diagnosed and classified in 400 patients with 3-day diary and 400 patients with 7-day diary, respectively. Then the difference in results of classification accuracy can be evaluated in patients with 3-day diary, compared with 7-day diary which is the golden standard for classification of the subtype of primary nocturnal enuresis.
次要结局
- The compliance rate of two type of urinating diary(1 month)
研究者
Mao Jianhua
Chief Physician
The Children's Hospital of Zhejiang University School of Medicine