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

Spinal Dysraphism Clinical Trial

Official title:

Determining Developmental and Clinical Markers Affecting Urinary Function of Children With Spinal Dysraphism: A Multicenter, Retrospective Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962086
• Other study ID #: 2210-092-1369
• Status: Recruiting
• Start date: October 22, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Seoul National University Hospital
• Contact: Kwanjin Park, MD/PHD
• Phone: +82-2-2072-0695
• Email: urodori9[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neural Tube Defects
• Spinal Dysraphism

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do

Sponsors (6)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Keimyung University Dongsan Medical Center, Pusan National University Yangsan Hospital, Samsung Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieving full continence at age 5	Achieving full urinary and fecal continence at age 5	Age 5
Primary	Achieving full continence at age 7	Achieving full urinary and fecal continence at age 7.	Age 7
Primary	Achieving full continence at age 10	Achieving full urinary and fecal continence at age 10	Age 10