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

Mao Jianhua

Status: Unknown

Conditions: Nocturnal Enuresis

Treatments: Diagnostic Test: the 3-day voiding diary; Diagnostic Test: the 7-day voiding diary

Study type: Interventional

Funder types: Other

Identifiers

NCT03199508

Voiding Diary Clinical Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 2 patient groups

the 3-day voiding diary group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: the 3-day voiding diary

the 7-day voiding diary group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: the 7-day voiding diary