NCT03199508

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

Prospective, Randomized, Controlled, Multicenter Clinical Trial of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Mao Jianhua · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nocturnal Enuresis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	the 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_TEST	the 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.

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-08-30
• Completion: 2018-09-30
• First posted: 2017-06-27
• Last updated: 2017-12-08

Locations

1 site across 1 country: China