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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoxetine | Experimental | patients will undergo maintenance therapy selective serotonin reuptake inhibitors, fluoxetine, 10 mg capsules once daily for 12 weeks |
|
| Placebo | Placebo Comparator | patients will undergo maintenance therapy Placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | Fluoxetine 10 mg capsules once daily for 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Hussiny abdelazim | Contact | 01064156383 | +2 | mohamedhussiny1@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mahmoud Elkenawy | Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university | Study Chair |
| Tamer El-sayed Helmy | Associate Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura urology and nephrology center | Recruiting | Al Mansurah | Dakahlia Governorate | 0502263717 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28208214 | Result | 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. | |
| 20006865 | Result | 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. |
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| ID | Term |
|---|---|
| D053206 | Nocturnal Enuresis |
| ID | Term |
|---|---|
| D004775 | Enuresis |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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A randomized controlled clinical trial
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Open Label
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| Placebo |
| Drug |
placebo for 12 months |
|
| Ahmed Abdelhalem | Lecturer of urology Urology and Nephrology center Faculty of medicine Mansoura university | Study Director |
| Mohamed Hussiny abdelazim | Resident in Urology Urology and Nephrology canter Mansoura University | Principal Investigator |
| 30216627 | Result | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |