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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

Tracking Information
First Submitted Date  ICMJE June 19, 2017
First Posted Date  ICMJE June 27, 2017
Last Update Posted Date December 8, 2017
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03199508 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Values of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children
Official Title  ICMJE Prospective, Randomized, Controlled, Multicenter Clinical Trial of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Nocturnal Enuresis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: the 3-day voiding diary
  • 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.
    Intervention: Diagnostic Test: the 7-day voiding diary
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 23, 2017)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2018
Estimated Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03199508
Other Study ID Numbers  ICMJE Voiding Diary Clinical Trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine
Study Sponsor  ICMJE Mao Jianhua
Collaborators  ICMJE
  • 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  ICMJE
Study Chair: Jianhua Mao, professor Department of Nephrology, Children's Hospital, Zhejiang University School of Medicine
PRS Account The Children's Hospital of Zhejiang University School of Medicine
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP