search
Back to results

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

Primary Purpose

Nocturnal Enuresis

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Fluoxetine
Placebo
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturnal Enuresis

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mansoura urology and nephrology centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fluoxetine

Placebo

Arm Description

patients will undergo maintenance therapy selective serotonin reuptake inhibitors, fluoxetine, 10 mg capsules once daily for 12 weeks

patients will undergo maintenance therapy Placebo for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 5, 2020
Last Updated
December 15, 2020
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT04676139
Brief Title
The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Enuresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled clinical trial
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluoxetine
Arm Type
Experimental
Arm Description
patients will undergo maintenance therapy selective serotonin reuptake inhibitors, fluoxetine, 10 mg capsules once daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patients will undergo maintenance therapy Placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
Fluoxetine 10 mg capsules once daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo for 12 months
Primary Outcome Measure Information:
Title
assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.
Description
counting the wet nights numbers between baseline and after 2 weeks of each treatment period
Time Frame
6 months
Secondary Outcome Measure Information:
Title
assess the safety of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.
Description
by counting the numbers of complication of each drugs
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Hussiny abdelazim
Phone
01064156383
Ext
+2
Email
mohamedhussiny1@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Elkenawy
Organizational Affiliation
Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tamer El-sayed Helmy
Organizational Affiliation
Associate Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelhalem
Organizational Affiliation
Lecturer of urology Urology and Nephrology center Faculty of medicine Mansoura university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Hussiny abdelazim
Organizational Affiliation
Resident in Urology Urology and Nephrology canter Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura urology and nephrology center
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
0502263717
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Hussiny abdelazim
Phone
01064156383
Ext
+2
Email
mohamedhussiny1@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28208214
Citation
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.
Results Reference
result
PubMed Identifier
20006865
Citation
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.
Results Reference
result
PubMed Identifier
30216627
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs