The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children
NCT ID: NCT04676139
Last Updated: 2020-12-19
Study Results
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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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2020-07-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fluoxetine
patients will undergo maintenance therapy selective serotonin reuptake inhibitors, fluoxetine, 10 mg capsules once daily for 12 weeks
Fluoxetine
Fluoxetine 10 mg capsules once daily for 12 months
Placebo
patients will undergo maintenance therapy Placebo for 12 weeks
Placebo
placebo for 12 months
Interventions
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Fluoxetine
Fluoxetine 10 mg capsules once daily for 12 months
Placebo
placebo for 12 months
Eligibility Criteria
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Inclusion Criteria
* Failed treatment with desmopressin.
* The enuresis alarm had either been tried without effect, or deemed unfeasible because of the family situation.
* All patients had either tried and failed combination therapy with anticholinergics or, because of contraindications, been unable to receive such therapy.
* Severe enuresis with at least seven wet nights out of 14
Exclusion Criteria
* Depression
* Severe psychiatric diseases
* Untreated constipation
8 Years
18 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Principal Investigators
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Mahmoud Elkenawy
Role: STUDY_CHAIR
Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university
Tamer El-sayed Helmy
Role: STUDY_DIRECTOR
Associate Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university
Ahmed Abdelhalem
Role: STUDY_DIRECTOR
Lecturer of urology Urology and Nephrology center Faculty of medicine Mansoura university
Mohamed Hussiny abdelazim
Role: PRINCIPAL_INVESTIGATOR
Resident in Urology Urology and Nephrology canter Mansoura University
Locations
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Mansoura urology and nephrology center
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Mohamed Hussiny abdelazim
Role: primary
References
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Neveus T. Pathogenesis of enuresis: Towards a new understanding. Int J Urol. 2017 Mar;24(3):174-182. doi: 10.1111/iju.13310. Epub 2017 Feb 16.
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.
Song P, Huang C, Wang Y, Wang Q, Zhu W, Yue Y, Wang W, Feng J, He X, Cui L, Wan T, Wen J. Comparison of desmopressin, alarm, desmopressin plus alarm, and desmopressin plus anticholinergic agents in the management of paediatric monosymptomatic nocturnal enuresis: a network meta-analysis. BJU Int. 2019 Mar;123(3):388-400. doi: 10.1111/bju.14539. Epub 2018 Oct 31.
Other Identifiers
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SSRI & Nocturnal enuresis
Identifier Type: -
Identifier Source: org_study_id