Clinical trial NCT04676139: The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children
Official title: The Safety and Efficacy of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nocturnal Enuresis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical trial
Primary purpose: TREATMENT

Brief summary: To determine whether there is a role for the selective serotonin reuptake inhibitors, fluoxetine, as therapy in the treatment of refractory primary monosymptomatic nocturnal enuresis in children , and whether there are side effects involved.


Eligibility criteria: Inclusion Criteria:

* Primary Monosymptomatic nocturnal enuresis
* 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:

* Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions
* Depression
* Severe psychiatric diseases
* Untreated constipation

Primary outcomes:
measure: assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.
timeFrame: 6 months
Secondary outcomes:
measure: assess the safety of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura urology and nephrology center
state: Dakahlia
Study officials:
affiliation: Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university
name: Mahmoud Elkenawy
role: STUDY_CHAIR
affiliation: Associate Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university
name: Tamer El-sayed Helmy
role: STUDY_DIRECTOR
affiliation: Lecturer of urology Urology and Nephrology center Faculty of medicine Mansoura university
name: Ahmed Abdelhalem
role: STUDY_DIRECTOR
affiliation: Resident in Urology Urology and Nephrology canter Mansoura University
name: Mohamed Hussiny abdelazim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.