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
1 other identifier
interventional
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedDecember 8, 2017
December 1, 2017
12 months
June 19, 2017
December 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Classification accuracy
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.
1 week
Secondary Outcomes (1)
The compliance rate of two type of urinating diary
1 month
Study Arms (2)
the 3-day voiding diary group
EXPERIMENTALThe 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.
the 7-day voiding diary group
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Children have been previously treated for nocturnal enuresis who use drugs or other therapeutic regimen.
- Secondary enuresis: after 6 months of non-enuresis period, children wet the bed again.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mao Jianhualead
- Jiangxi Province Children's Hospitalcollaborator
- Yuying Children's Hospital of Wenzhou Medical Universitycollaborator
- Shenzhen Children's Hospitalcollaborator
- Guangzhou Women and Children's Medical Centercollaborator
- Nanjing Children's Hospitalcollaborator
- Soochow Universitycollaborator
Study Sites (1)
The Children Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006, China
Related Publications (4)
Kaneko K. Treatment for nocturnal enuresis: the current state in Japan. Pediatr Int. 2012 Feb;54(1):8-13. doi: 10.1111/j.1442-200X.2011.03554.x.
PMID: 22222057BACKGROUNDNeveus T, Eggert P, Evans J, Macedo A, Rittig S, Tekgul S, Vande Walle J, Yeung CK, Robson L; International Children's Continence Society. Evaluation of and treatment for monosymptomatic enuresis: a standardization document from the International Children's Continence Society. J Urol. 2010 Feb;183(2):441-7. doi: 10.1016/j.juro.2009.10.043. Epub 2009 Dec 14.
PMID: 20006865BACKGROUNDHansen MN, Rittig S, Siggaard C, Kamperis K, Hvistendahl G, Schaumburg HL, Schmidt F, Rawashdeh Y, Djurhuus JC. Intra-individual variability in nighttime urine production and functional bladder capacity estimated by home recordings in patients with nocturnal enuresis. J Urol. 2001 Dec;166(6):2452-5.
PMID: 11696810BACKGROUNDSchultz-Lampel D, Steuber C, Hoyer PF, Bachmann CJ, Marschall-Kehrel D, Bachmann H. Urinary incontinence in children. Dtsch Arztebl Int. 2011 Sep;108(37):613-20. doi: 10.3238/arztebl.2011.0613. Epub 2011 Sep 16.
PMID: 21977217BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianhua Mao, professor
Department of Nephrology, Children's Hospital, Zhejiang University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
June 19, 2017
First Posted
June 27, 2017
Study Start
September 1, 2017
Primary Completion
August 30, 2018
Study Completion
September 30, 2018
Last Updated
December 8, 2017
Record last verified: 2017-12