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

NCT ID: NCT03199508

Last Updated: 2017-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Nocturnal Enuresis

Keywords

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Nocturnal Enuresis Voiding Diary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type EXPERIMENTAL

the 3-day voiding diary

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type ACTIVE_COMPARATOR

the 7-day voiding diary

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangxi Province Children's Hospital

OTHER

Sponsor Role collaborator

Yuying Children's Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Shenzhen Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Nanjing Children's Hospital

OTHER

Sponsor Role collaborator

Soochow University

OTHER

Sponsor Role collaborator

Mao Jianhua

OTHER

Sponsor Role lead

Responsible Party

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Mao Jianhua

Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jianhua Mao, professor

Role: STUDY_CHAIR

Department of Nephrology, Children's Hospital, Zhejiang University School of Medicine

Locations

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The Children Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianhua Mao, professor

Role: CONTACT

Phone: 86-571-87061007

Email: [email protected]

Facility Contacts

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Qiang Shu, MD & PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22222057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20006865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11696810 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21977217 (View on PubMed)

Related Links

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http://kreader.cnki.net/Kreader/CatalogViewPage.aspx?dbCode=CJFD&filename=LCAK201410027&tablename=CJFD2014&compose=&first=1&uid=WEEvREcwSlJHSldRa1FhdXNXYXJwZDB6b0pXbHV0Wkx3VFNDUGI5VXpFQT0=$9A4hF_YAuvQ5obgVAqNKPCYcEjKensW4ggI8Fm4gTkoUKaID8j8gFw!!

Children's monosymptomatic enuresis therapeutic regimen in China

Other Identifiers

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Voiding Diary Clinical Trial

Identifier Type: -

Identifier Source: org_study_id