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

NCT06185361 | Unknown DMC

• 1 other identifier: Nocturnal Enuresis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nocturnal Enuresis; Enuresis; Enuresis, Nocturnal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

fluoxetine

ACTIVE COMPARATOR

selective serotonin reuptake inhibitors fluoxetine 20 mg for 12 weeks

Drug: Fluoxetine 20 MG

desmopressin

ACTIVE COMPARATOR

0.2 mg desmopressin tablet for 12 weeks

Drug: Desmopressin

Interventions

Fluoxetine 20 MG DRUG

fluoxetine

fluoxetine

Desmopressin DRUG

desmopressin

desmopressin

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Faculty of medicine, Fayoum University

Al Fayyum, 63514, Egypt

Location

MeSH Terms

Conditions

Nocturnal Enuresis; Enuresis

Interventions

Fluoxetine; Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: December 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

EG (1)