Nocturnal Enuresis
Conditions
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.
Interventions
DRUGFluoxetine
Fluoxetine 10 mg capsules once daily for 12 months
DRUGPlacebo
placebo for 12 months
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention model description
A randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children. | 6 months | counting the wet nights numbers between baseline and after 2 weeks of each treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assess the safety of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children. | 6 months | by counting the numbers of complication of each drugs |
Countries
Egypt
Contacts
Primary ContactMohamed Hussiny abdelazim
Outcome results
None listed