Nocturnal Enuresis
Conditions
Keywords
Nocturnal Enuresis, Voiding Diary
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.
Interventions
DIAGNOSTIC_TESTthe 3-day voiding diary
The 3-day voiding diary is a medical record which need participants to fill in a table about urine volume for 2 days and 3 nights.
DIAGNOSTIC_TESTthe 7-day voiding diary
The 7-day voiding diary is a medical record which need participants to fill in a table about urine volume and drinking water volume for 4 days and 7 nights.
Sponsors
Jiangxi Province Children's Hospital
Yuying Children's Hospital of Wenzhou Medical University
Shenzhen Children's Hospital
Guangzhou Women and Children's Medical Center
Nanjing Children's Hospital
Soochow University
Mao Jianhua
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
The investigators use two sets of parallel controls. The experimental group use the 3-day voiding diary and the control group use the 7-day voiding diary.
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Classification accuracy | 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
| Measure | Time frame | Description |
|---|---|---|
| The compliance rate of two type of urinating diary | 1 month | The recovery rate would be evaluated when the 3-day diary and 7-day diary were collected in all patients. The compliance rate of two type of urinating diary was evaluated by the recovery rate of diary between 3-day diary and 7-day diary. |
Countries
China
Contacts
Primary ContactJianhua Mao, professor
Outcome results
None listed