Nocturnal Enuresis Clinical Trial
Official title:
Prospective, Randomized, Controlled, Multicenter Clinical Trial of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | The Children Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
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 |
China,
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
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 |
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