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

The Safety and Efficacy of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Nocturnal Enuresis
• Intervention / Treatment: Drug: Fluoxetine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mohamed Hussiny abdelazim; Phone Number: +2 01064156383; Email: mohamedhussiny1@yahoo.com

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 0502263717
      • Recruiting
      • Mansoura urology and nephrology center
      • Contact: Mohamed Hussiny abdelazim; Phone Number: +2 01064156383; Email: mohamedhussiny1@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluoxetine; patients will undergo maintenance therapy selective serotonin reuptake inhibitors, fluoxetine, 10 mg capsules once daily for 12 weeks	Drug: Fluoxetine; Fluoxetine 10 mg capsules once daily for 12 months
Placebo Comparator: Placebo; patients will undergo maintenance therapy Placebo for 12 weeks	Drug: Placebo; placebo for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.	counting the wet nights numbers between baseline and after 2 weeks of each treatment period	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess the safety of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.	by counting the numbers of complication of each drugs	6 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Mahmoud Elkenawy, Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university; Study Director: Tamer El-sayed Helmy, Associate Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university; Study Director: Ahmed Abdelhalem, Lecturer of urology Urology and Nephrology center Faculty of medicine Mansoura university; Principal Investigator: Mohamed Hussiny abdelazim, Resident in Urology Urology and Nephrology canter Mansoura University

Publications and helpful links

General Publications

• Neveus T. Pathogenesis of enuresis: Towards a new understanding. Int J Urol. 2017 Mar;24(3):174-182. doi: 10.1111/iju.13310. Epub 2017 Feb 16.
• Neveus T, Eggert P, Evans J, Macedo A, Rittig S, Tekgul S, Vande Walle J, Yeung CK, Robson L; International Children's Continence Society. Evaluation of and treatment for monosymptomatic enuresis: a standardization document from the International Children's Continence Society. J Urol. 2010 Feb;183(2):441-7. doi: 10.1016/j.juro.2009.10.043. Epub 2009 Dec 14.
• Song P, Huang C, Wang Y, Wang Q, Zhu W, Yue Y, Wang W, Feng J, He X, Cui L, Wan T, Wen J. Comparison of desmopressin, alarm, desmopressin plus alarm, and desmopressin plus anticholinergic agents in the management of paediatric monosymptomatic nocturnal enuresis: a network meta-analysis. BJU Int. 2019 Mar;123(3):388-400. doi: 10.1111/bju.14539. Epub 2018 Oct 31.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 5, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

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; Urinary Incontinence; Enuresis; Nocturnal Enuresis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: SSRI & Nocturnal enuresis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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