The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children

Mansoura University

Status and phase: Unknown; Phase 3

Conditions: Nocturnal Enuresis

Treatments: Drug: Placebo; Drug: Fluoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT04676139

SSRI & Nocturnal enuresis

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups, including a placebo group

Fluoxetine

Experimental group

Description:

patients will undergo maintenance therapy selective serotonin reuptake inhibitors, fluoxetine, 10 mg capsules once daily for 12 weeks

Treatment:

Drug: Fluoxetine

Placebo

Placebo Comparator group

Description:

patients will undergo maintenance therapy Placebo for 12 weeks

Treatment:

Drug: Placebo