Egypt: Study on Fluoxetine for PMNE in Children

A study published in the Journal of Urology has concluded the safety of Fluoxetine, which is a selective serotonin reuptake inhibitor (SSRI), in children for the management of refractory primary monosymptomatic nocturnal enuresis (PMNE).

Nocturnal enuresis (NE) affects 15% of children. The condition has negative psychological, emotional, and social impacts. The treatment improves a child's self-esteem and mental health.

Alarm therapy, desmopressin, anticholinergics, and tricyclic antidepressants are the standard treatment options available. However, the treatment efficacy remains limited, and nearly 50% of children are refractory to treatment, while treatment discontinuation leads to higher relapse rates.

The anti-enuretic effect of Fluoxetine was first reported by Mesaros. The literature mentions conflicting results with SSRIs like sertraline, fluvoxamine, and paroxetine to treat NE.

Based on the above background, a study was conducted by researchers led by Dr. Mohamed Hussiny and Dr. Abdelwahab Hashem from the Department of Urology at Mansoura University to evaluate the fluoxetine efficacy and safety in children for treating PMNE.

Main Points of Research

• Children aged 8-18 years with severe PMNE history of being unresponsive to alarm therapy, desmopressin, and anticholinergics were screened for the study.
• A total of 150 children were enrolled. There were two groups: the Fluoxetine group (56 children) and the Placebo group (54 children).
• Patients were given 10 mg of fluoxetine once daily for 12 weeks.
• The primary outcome was treatment response (International Children's Continence Society terminology).
• The secondary outcomes measured were adverse effects and nighttime arousal.
• The complete and partial responses achieved in the fluoxetine group and placebo group after four weeks were 7.1% and 66.1% versus 0% and 16.7%, respectively. The P value was <0.001.
• At 12 weeks, complete and partial responses in the fluoxetine and placebo group were 10.7% and 21.4% vs. 0% and 14.8%, respectively. The P value was 0.023. This significantly indicated a declined response rate.
• Patients in the fluoxetine group had a lower number of wet nights at 4, 8, and 12 weeks of treatment than placebo, with p values <0.001, <0.001, and 0.003, respectively.
• The mean number of wet nights in Fluoxetine-treated patients was worse at 12 weeks compared to 4 weeks of treatment.
• In the fluoxetine group, after 4 and 8 weeks, improved arousal was 10.7%.
• After 12 weeks, improved arousal was 14.3% in the fluoxetine group compared to 1.9% in the placebo (P = .017).

They wrote, "The number of wet nights was significantly reduced in the fluoxetine group than placebo."

The researchers explained that Fluoxetine is a safe treatment modality for refractory PMNE children and is associated with a good initial response. The response declines at 12 weeks. The response to fluoxetine therapy is not significantly associated with age, gender, BMI, family history, etc., they mentioned.

Further Reading

The Safety and Efficacy of Fluoxetine for the Treatment of Refractory Primary Monosymptomatic Nocturnal Enuresis in Children. Mohamed Hussiny et al.