Clinical Values of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children

Not Applicable

• Conditions: Nocturnal Enuresis
• Interventions: Diagnostic Test: the 7-day voiding diary; Diagnostic Test: the 3-day voiding diary

• Registration Number: NCT03199508
• Lead Sponsor: Mao Jianhua

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.

Study Timeline

• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-23
• Study First Posted: 2017-06-27
• Study Start: 2017-09-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-08
• Primary Completion: 2018-08-30
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the 7-day voiding diary group	the 7-day voiding diary	The 7-day voiding diary group is as the control group in which several centers use the 7-day voiding diary by cluster randomization. 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. The 3-day voiding diary group is the experimental group in which several centers use the 3-day voiding diary by cluster randomization.
the 3-day voiding diary group	the 3-day voiding diary	The 3-day voiding diary group is as the experimental group in which several centers use the 3-day voiding diary by cluster randomization. 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Children Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China