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

Primary Purpose

Nocturnal Enuresis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the 3-day voiding diary
the 7-day voiding diary
Sponsored by
Mao Jianhua
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nocturnal Enuresis focused on measuring Nocturnal Enuresis, Voiding Diary

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Children Hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the 3-day voiding diary group

the 7-day voiding diary group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The compliance rate of two type of urinating diary
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.

Full Information

First Posted
June 19, 2017
Last Updated
December 7, 2017
Sponsor
Mao Jianhua
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
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1. Study Identification

Unique Protocol Identification Number
NCT03199508
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mao Jianhua
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Enuresis
Keywords
Nocturnal Enuresis, Voiding Diary

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the 3-day voiding diary group
Arm Type
Experimental
Arm Description
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.
Arm Title
the 7-day voiding diary group
Arm Type
Active Comparator
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
the 3-day voiding diary
Intervention Description
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
Intervention Name(s)
the 7-day voiding diary
Intervention Description
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 Measure Information:
Title
Classification accuracy
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
The compliance rate of two type of urinating diary
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Mao, professor
Phone
86-571-87061007
Email
maojh88@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Mao, professor
Organizational Affiliation
Department of Nephrology, Children's Hospital, Zhejiang University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
The Children Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Shu, MD & PhD
Phone
0086 571 86670006
Email
shuqiang@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22222057
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.
Results Reference
background
PubMed Identifier
20006865
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.
Results Reference
background
PubMed Identifier
11696810
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.
Results Reference
background
PubMed Identifier
21977217
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.
Results Reference
background
Links:
URL
http://kreader.cnki.net/Kreader/CatalogViewPage.aspx?dbCode=CJFD&filename=LCAK201410027&tablename=CJFD2014&compose=&first=1&uid=WEEvREcwSlJHSldRa1FhdXNXYXJwZDB6b0pXbHV0Wkx3VFNDUGI5VXpFQT0=$9A4hF_YAuvQ5obgVAqNKPCYcEjKensW4ggI8Fm4gTkoUKaID8j8gFw!!
Description
Children's monosymptomatic enuresis therapeutic regimen in China

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

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