Prospective, Randomized, Controlled, Multicenter Clinical Trial of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nocturnal Enuresis
- Sponsor
- Mao Jianhua
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Classification accuracy
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Mao Jianhua
Chief Physician
The Children's Hospital of Zhejiang University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Classification accuracy
Time Frame: 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.
Secondary Outcomes
- The compliance rate of two type of urinating diary(1 month)