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

NCT ID: NCT06185361

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Nocturnal Enuresis Enuresis Enuresis, Nocturnal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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fluoxetine

selective serotonin reuptake inhibitors fluoxetine 20 mg for 12 weeks

Group Type ACTIVE_COMPARATOR

Fluoxetine 20 MG

Intervention Type DRUG

fluoxetine

desmopressin

0.2 mg desmopressin tablet for 12 weeks

Group Type ACTIVE_COMPARATOR

Desmopressin

Intervention Type DRUG

desmopressin

Interventions

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Fluoxetine 20 MG

fluoxetine

Intervention Type DRUG

Desmopressin

desmopressin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fayoum University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hesham Abdel Azim El Helaly

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine, Fayoum University

Al Fayyum, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Nocturnal Enuresis

Identifier Type: -

Identifier Source: org_study_id