NCT04676139

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2020

Enrollment Period

2.3 years

First QC Date

December 5, 2020

Last Update Submit

December 15, 2020

Conditions

Nocturnal Enuresis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • assess the safety of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.

    6 months

Study Arms (2)

Fluoxetine

EXPERIMENTAL

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

Drug: Fluoxetine

Placebo

PLACEBO COMPARATOR

patients will undergo maintenance therapy Placebo for 12 weeks

Drug: Placebo

Interventions

FluoxetineDRUG

Fluoxetine 10 mg capsules once daily for 12 months

Fluoxetine
PlaceboDRUG

placebo for 12 months

Placebo

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions
  • Depression
  • Severe psychiatric diseases
  • Untreated constipation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura urology and nephrology center

Al Mansurah, Dakahlia Governorate, 0502263717, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28208214RESULT

  • 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.

    PMID: 20006865RESULT

  • 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.

    PMID: 30216627RESULT

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Mahmoud Elkenawy

    Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

  • Mohamed Hussiny abdelazim

    Resident in Urology Urology and Nephrology canter Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Hussiny abdelazim

CONTACT

01064156383mohamedhussiny1@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2020

First Posted

December 19, 2020

Study Start

July 1, 2020

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

December 19, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)