Identifying factors affecting urinary function in children with spinal dysraphism
Determining Developmental and Clinical Markers Affecting Urinary Function of Children With Spinal Dysraphism: A Multicenter, Retrospective Cohort
Seoul National University Hospital · NCT05962086
This study looks at how different factors affect bladder control in children with spinal dysraphism to help improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | N/A to 10 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 6 sites (Yangsan, Gyeongsangnam-do and 5 other locations) |
| Trial ID | NCT05962086 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to identify developmental and clinical biomarkers that influence urinary incontinence in children diagnosed with spinal dysraphism at ages 5, 7, and 10. By analyzing various neuro-urological clinical factors, including the type of spinal dysraphism and results from urodynamics tests, the study seeks to establish correlations that could inform future treatment approaches. The research is retrospective, utilizing existing patient data to draw insights into urinary function outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with spinal dysraphism who have been receiving follow-up care for neurogenic bladder.
Not a fit: Patients without a diagnosis of spinal dysraphism or those not experiencing urinary incontinence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for urinary incontinence in children with spinal dysraphism.
How similar studies have performed: While similar studies have explored urinary function in related conditions, this specific approach focusing on developmental and clinical biomarkers in spinal dysraphism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Yangsan, Gyeongsangnam-do and 5 other locations
- Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do, Korea, Republic of (RECRUITING)
- Keimyung University Dongsan Medical Center — Daegu, Korea, Republic of (RECRUITING)
- Asan Medical Center — Seoul, Korea, Republic of (RECRUITING)
- Samsung Medical Center — Seoul, Korea, Republic of (RECRUITING)
- Seoul National University Hospital — Seoul, Korea, Republic of (RECRUITING)
- Yonsei University Severance Hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Sang Woon Kim, MD/PHD — Severance Hospital
- Study coordinator: Kwanjin Park, MD/PHD
- Email: urodori9@snu.ac.kr
- Phone: +82-2-2072-0695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Dysraphism, Spina Bifida, Neurogenic Bladder, Neurogenic Detrusor Overactivity, Detrusor Overactivity, Incontinence