Nocturnal Enuresis Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2022 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura urology and nephrology center | Mansoura | Dakahlia |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
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 — View Citation
Nevéus 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. Review. — View 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 en — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children. | counting the wet nights numbers between baseline and after 2 weeks of each treatment period | 6 months | |
Secondary | assess the safety of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children. | by counting the numbers of complication of each drugs | 6 months |
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