Determining Developmental and Clinical Markers Affecting Urinary Function of Children With Spinal Dysraphism
1 other identifier
observational
1,500
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Typical duration for all trials
6 active sites
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
October 22, 2022
CompletedFirst Submitted
Initial submission to the registry
June 10, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJuly 27, 2023
July 1, 2023
2.2 years
June 10, 2023
July 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Eligibility Criteria
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.
You may qualify if:
- \- Those who received spinal dysraphism diagnosis (ICD Code: Q05.1-05.9) and have been following up and receiving treatments due to neurogenic bladder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Asan Medical Centercollaborator
- Severance Hospitalcollaborator
- Samsung Medical Centercollaborator
- Keimyung University Dongsan Medical Centercollaborator
- Pusan National University Yangsan Hospitalcollaborator
Study Sites (6)
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kwanjin Park, MD/PHD
Seoul National University Hospital
- PRINCIPAL INVESTIGATOR
Sang Woon Kim, MD/PHD
Severance Hospital
- PRINCIPAL INVESTIGATOR
Sang Hoon Song, MD/PHD
Asan Medical Center
- PRINCIPAL INVESTIGATOR
Minki Baek, MD/PHD
Samsung Medical Center
- PRINCIPAL INVESTIGATOR
Jae Min Chung, MD/PHD
Pusan National University Yangsan Hospital
- PRINCIPAL INVESTIGATOR
Ji Yong Ha, MD/PHD
Keimyung University Dongsan Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 10, 2023
First Posted
July 27, 2023
Study Start
October 22, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
July 27, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share
Not willing to share individual participant data (IPD) for this particular study.