Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis.

Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis. A Randomised Controlled Trial

To determine whether there is a role for the selective serotonin reuptake inhibitors fluoxetine versus desmopressin in the treatment of nocturnal enuresis in children who have not responded to standard nonpharmacological urotherapy, and whether there are side effects involved.

Study Overview

• Status: Active, not recruiting
• Conditions: Enuresis; Nocturnal Enuresis; Enuresis, Nocturnal
• Intervention / Treatment: Drug: Fluoxetine 20 MG; Drug: Desmopressin

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt, 63514
    • Faculty of medicine, Fayoum university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 7 years
2. Severe enuresis with at least (50%) seven wet nights out of 14
3. Failed treatment
4. The enuresis alarm was either ineffective or considered impractical due to the family circumstances.

Exclusion Criteria:

1. Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions
2. Patients with psychiatric disorders and behavioral disorders including depression, attention-deficit/hyperactivity disorder.
3. Untreated constipation
4. Contraindications to fluoxetine or desmopressin treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fluoxetine; selective serotonin reuptake inhibitors fluoxetine 20 mg for 12 weeks	Drug: Fluoxetine 20 MG; fluoxetine
Active Comparator: desmopressin; 0.2 mg desmopressin tablet for 12 weeks	Drug: Desmopressin; desmopressin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The children will be non-responders, partial responders, or full responders to therapy	The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society "ICCS definitions" (i.e., if the reduction of enuresis frequency was below or above 50% or 90%, respectively)	three months

Collaborators and Investigators

• Sponsor: Fayoum University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Nocturnal Enuresis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Natriuretic Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Hemostatics; Coagulants; Antidiuretic Agents; Selective Serotonin Reuptake Inhibitors; Fluoxetine; Deamino Arginine Vasopressin
• Other Study ID Numbers: Nocturnal Enuresis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No