Clinical trial NCT03199508: Clinical Values of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children
Official title: Prospective, Randomized, Controlled, Multicenter Clinical Trial of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nocturnal Enuresis
Keywords: Nocturnal Enuresis
Voiding Diary
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
Collaborators: name: Jiangxi Province Children's Hospital
name: Yuying Children's Hospital of Wenzhou Medical University
name: Shenzhen Children's Hospital
name: Guangzhou Women and Children's Medical Center
name: Nanjing Children's Hospital
name: Soochow University
First posted: 2017-06-27
Enrollment: 800
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Classification accuracy
timeFrame: 1 week
Secondary outcomes:
measure: The compliance rate of two type of urinating diary
timeFrame: 1 month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Children Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Department of Nephrology, Children's Hospital, Zhejiang University School of Medicine
name: Jianhua Mao, professor
role: STUDY_CHAIR
References:
citation: 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.
citation: Neveus 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.
citation: Hansen 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.
citation: Schultz-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.