NCT05190601

Brief Summary

Background: Enuresis nocturna is an important social and psychological problem in children. Uroflowmetry is an important test used to investigate lower urinary tract symptoms.. Objective:To evaluate the uroflowmetry (UFM) results of children with nocturnal enuresis (NE). Method: The uroflowmetry findings of healthy and visualized children without any urinary symptoms and who were prospectively admitted to the urology and pediatric surgery outpatient clinic with the complaint of Enuresis nocturna between January 2020 and July 2021 were compared. Information (anamnesis, physical examination, radiology results and laboratory tests) and uroflowmetry results of NE and healthy children included in the study were recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

1.6 years

First QC Date

December 11, 2021

Last Update Submit

December 29, 2021

Conditions

Enuresis

Keywords

enuresis nocturnauroflowmetrychild

Outcome Measures

Primary Outcomes (1)

  • uroflowmetry

    ml/s

    2 years

Study Arms (1)

Group 1

Enuresis nocturna with children

Device: uroflowmetry

Interventions

uroflowmetryDEVICE

Qmax(ml/s),Qav(ml/s),Volume (ml)

Group 1

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric,primary monosymptomatic enuresis nocturna, 6-16 years, without comorbidity

You may qualify if:

  • Primer monosymptomatic enuresis nocturna

You may not qualify if:

  • Urinary infectious Diabetes Spina bifida, Epispadias, Hipospadias VUR Extrophia Vesica Epilepsy Cerebral Palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hisar Intercontinental Hospital

Istanbul, 34768, Turkey (Türkiye)

Location

MeSH Terms

Conditions

EnuresisNocturnal Enuresis

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 11, 2021

First Posted

January 13, 2022

Study Start

January 1, 2020

Primary Completion

July 30, 2021

Study Completion

December 11, 2021

Last Updated

January 13, 2022

Record last verified: 2021-12

Locations

TU(1)