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

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ClinicalTrials.gov Identifier: NCT03199508
Recruitment Status : Unknown
Verified December 2017 by Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine.
Recruitment status was:  Recruiting
First Posted : June 27, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Nocturnal Enuresis Diagnostic Test: the 3-day voiding diary Diagnostic Test: the 7-day voiding diary Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
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.
Primary Purpose: Diagnostic
Official Title: Prospective, Randomized, Controlled, Multicenter Clinical Trial of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: the 3-day voiding diary group
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.
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.

Active Comparator: the 7-day voiding diary group
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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The compliance rate of two type of urinating diary [ Time Frame: 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.



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199508


Contacts
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Contact: Jianhua Mao, professor 86-571-87061007 maojh88@126.com

Locations
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China, Zhejiang
The Children Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Qiang Shu, MD & PhD    0086 571 86670006    shuqiang@zju.edu.cn   
Sponsors and Collaborators
Mao Jianhua
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
Investigators
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Study Chair: Jianhua Mao, professor Department of Nephrology, Children's Hospital, Zhejiang University School of Medicine

Additional Information:
Publications:
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Responsible Party: Mao Jianhua, Chief Physician, The Children's Hospital of Zhejiang University School of Medicine
ClinicalTrials.gov Identifier: NCT03199508    
Other Study ID Numbers: Voiding Diary Clinical Trial
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine:
Nocturnal Enuresis
Voiding Diary
Additional relevant MeSH terms:
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Enuresis
Urinary Incontinence
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms