Safety and efficacy of fluoxetine, selective serotonin reuptake inhibitor, for the treatment of refractory monosymptomatic nocturnal enuresis in children: A randomized placebo-controlled study
Mohamed Hussiny Abdelazim, MBBCH, Resident in urology, Abdelwahab Hashem, MD, Ahmed Abdelhalim, MD, Mohamed A.Soltan, MSc, Mahmoud R. El-Kenawy, MD, Ashraf T. Hafez, MD, Mohamed E. Dawaba, MD, Tamer Helmy, MD.
Urology and Nephrology center , Mansoura university, Mansoura, Egypt.
Background : Nocturnal Enuresis (NE) is a common medical condition in children. It affects millions of children throughout the world and is associated with a significant negative impact on self-esteem and health-related Quality of life . Behavioral therapy , alarm treatment and desmopressin are first-line treatments. Treatment options for refractory NE are limited. This study aimed at investigating the efficacy and safety of fluoxetine for treatment of refractory primary monosymptomatic NE in children.
Methods : Children aged 8-18 years with primary monosymptomatic NE refractory to desmopressin treatment were screened for eligibility. Patients with daytime symptoms, constipation, underlying urologic, neurological, endocrinological , cardiac or psychiatric conditions were excluded. Parents who agreed to enroll their children in the study provided informed consents. After sample size calculation, patients were randomly assigned to the fluoxetine (study) or placebo groups in a 1:1 ratio. Patients in the study group were maintained on 10 mg of fluoxetine once daily for 12 weeks. Medication logs were used to monitor medication compliance. The primary study outcome was reduction in the number of wet nights at 4, 8 and 12 weeks of therapy. Patients with < 50% reduction of wet nights were considered non-responders. Patients with 50-99% reduction of wet nights were considered partial responders (PR) and those with complete nighttime dryness were considered complete responders (CR). Treatment adverse effects were secondary outcomes.
Results: Between July 2020 and March 2021 , a total of 120 children with a mean age of 11.8 + 2.46 years were enrolled. Those who continued the follow up duration were 110 patients . a total of 56 children were assigned to the fluoxetine and 54 to the placebo groups. Baseline enuresis severity was similar between both study groups. After 4 weeks of therapy, 7.1% of fluoxetine group achieved CR and 66.1% achieved PR (versus 0% and 16.7% of placebo, respectively; p <0.001). The response rate declined at 12
weeks of therapy with CR achieved in 10.7% and PR in 21.4% of the fluoxetine group (versus 0% and 14.8% of the placebo, respectively; p=0.023). Fluoxetine treatment was discontinued before the planned study duration in 4 patients of the fluoxetine group due to treatment-related adverse effects (dizziness in two patients, mood changes in one and hypersensitivity in another).
Conclusions: Fluoxetine, selective serotonin reuptake inhibitor, achieves good initial response in patients with primary refractory monosymptomatic nocturnal enuresis. However, the response rate declines significantly at 12 weeks of therapy.
|Fluoxetine (study) group (N=56)||Placebo (control) group (N=54)||P value|
|Mean baseline number of wet nights / 2 weeks||12.1 + 2.19||11.8 + 2.22||0.486|
|Treatment response at 4 weeks (%)||<0.001|
|Complete response||4 (7.1)||0|
|Partial response||37 (66.1)||9 (16.7)|
|No response||15 (26.8)||45 (83.3)|
|Treatment response at 8 weeks (%)||<0.001|
|Complete response||4 (7.1)||1 (1.9)|
|Partial response||30 (53.6)||6 (11.1)|
|No response||22 (39.3)||47 (87)|
|Treatment response at 12 weeks (%)||0.023|
|Complete response||6 (10.7)||0|
|Partial response||12 (21.4)||8 (14.8)|
|No response||38 (67.9)||46 (85.2)|
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