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

Sponsor
Mansoura University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04676139
Collaborator
(none)
100
1
2
29
3.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A randomized controlled clinical trialA randomized controlled clinical trial
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
Official Title:
The Safety and Efficacy of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children: A Randomized Controlled Trial
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children. [6 months]

    counting the wet nights numbers between baseline and after 2 weeks of each treatment period

Secondary Outcome Measures

  1. assess the safety of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children. [6 months]

    by counting the numbers of complication of each drugs

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura urology and nephrology center Mansoura Dakahlia Egypt 0502263717

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT04676139
Other Study ID Numbers:
  • SSRI & Nocturnal enuresis
First Posted:
Dec 19, 2020
Last Update Posted:
Dec 19, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 19, 2020