Uroflowmetry in Children With Enuresis Nocturnal | NCT05190601

Studies
Uroflowmetry in Children With Enuresis Nocturnal

NCT05190601

Sponsor

Hisar Intercontinental Hospital

Status

Completed

Last Update Posted

Jan 13, 2022Actual

Enrollment

180Actual

Phase

Not provided

Conditions

Enuresis

Interventions

uroflowmetry

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jul 30, 2021Actual

Completion Date

Dec 11, 2021Actual

First Submitted Date

Dec 11, 2021

First Submission Date that Met QC Criteria

Dec 29, 2021

First Posted Date

Jan 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2021

Last Update Posted Date

Jan 13, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Basri Cakiroglu, Clinical Professor, Hisar Intercontinental HospitalPrincipal Investigator

Lead Sponsor

Hisar Intercontinental HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

SMale and Female,

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

18 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Enuresis nocturna with children	Device: uroflowmetry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
uroflowmetry	Device	Qmax(ml/s),Qav(ml/s),Volume (ml)	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
uroflowmetry	ml/s	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primer monosymptomatic enuresis nocturna

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hisar Intercontinental Hospital		Istanbul		34768	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D004775	Enuresis
D053206	Nocturnal Enuresis

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided