Determining Developmental and Clinical Markers Affecting... | NCT05962086

Studies
Determining Developmental and Clinical Markers Affecting Urinary Function of Children With Spinal Dysraphism

NCT05962086

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jul 27, 2023Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Spinal Dysraphism

Interventions

Not provided

Countries

South Korea

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Jun 10, 2023

First Submission Date that Met QC Criteria

Jul 18, 2023

First Posted Date

Jul 27, 2023Actual

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

Jul 18, 2023

Last Update Posted Date

Jul 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kwanjin Park, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Asan Medical Center	OTHER
Severance Hospital	OTHER
Samsung Medical Center	OTHER
Keimyung University Dongsan Medical Center

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

To identify developmental and clinical biomarkers that affect urinary incontinence at the ages of 5, 7, and 10 according to different neuro-urological clinical factors.

Detailed Description

This retrospective observational cohort study aims to identify developmental and clinical biomarkers that affect urinary incontinence at the ages of 5, 7, and 10 according to the types of spinal dysraphism, conus medullaris location, and urodynamics test results.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Achieving full continence at age 5	Achieving full urinary and fecal continence at age 5	Age 5
Achieving full continence at age 7	Achieving full urinary and fecal continence at age 7.	Age 7
Achieving full continence at age 10	Achieving full urinary and fecal continence at age 10	Age 10

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Those who received spinal dysraphism diagnosis (ICD Code: Q05.1-05.9) and have been following up and receiving treatments due to neurogenic bladder.

Exclusion Criteria:

- As the study is a retrospective study, there is no exclusion criteria.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

10 Years

Standard Ages

Child

Study Population

Spinal dysraphism (SD) is a congenital abnormality that results in an abnormal structure in the spine, including the bony structure, the spinal cord, and the nerve roots. Patients with SD often suffer from multiple complications such as neurological problems, urological problems, orthopedic problems, and pain. A numerous studies have demonstrated that at least 70-90% of the patients experience neurogenic bladder or neurogenic detrusor overactivity, which affects both physical and psychosocial aspects of quality of life.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kwanjin Park, MD/PHD	Contact	+82-2-2072-0695		urodori9@snu.ac.kr
Louis Kim, BS	Contact	+82-10-4201-0636		kim.hyunkyu11@gmail.com

Overall Officials

Name	Affiliation	Role
Kwanjin Park, MD/PHD	Seoul National University Hospital	Study Chair
Sang Woon Kim, MD/PHD	Severance Hospital	Principal Investigator
Sang Hoon Song, MD/PHD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pusan National University Yangsan Hospital	Recruiting	Yangsan	Gyeongsangnam-do		South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not willing to share individual participant data (IPD) for this particular study.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016135	Spinal Dysraphism
D001750	Urinary Bladder, Neurogenic
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D009436	Neural Tube Defects
D009421	Nervous System Malformations
D009422	Nervous System Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided