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

Nocturnal Enuresis Clinical Trial

Official title:

Prospective, Randomized, Controlled, Multicenter Clinical Trial of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03199508
• Other study ID #: Voiding Diary Clinical Trial
• Status: Recruiting
• Phase: N/A
• First received: June 19, 2017
• Last updated: December 7, 2017
• Start date: September 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: December 2017
• Source: The Children's Hospital of Zhejiang University School of Medicine
• Contact: Jianhua Mao, professor
• Phone: 86-571-87061007
• Email: maojh88[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: September 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The Children Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (7)

Lead Sponsor	Collaborator
Mao Jianhua	Guangzhou Women and Children's Medical Center, Jiangxi Province Children's Hospital, Nanjing Children's Hospital, Shenzhen Children's Hospital, Soochow University, Yuying Children's Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View Citation

Neveus T, Eggert P, Evans J, Macedo A, Rittig S, Tekgül 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 month

External Links

•   Children's monosymptomatic enuresis therapeutic regimen in China