Clinical trial NCT05962086: Determining Developmental and Clinical Markers Affecting Urinary Function of Children With Spinal Dysraphism
Official title: Determining Developmental and Clinical Markers Affecting Urinary Function of Children With Spinal Dysraphism: A Multicenter, Retrospective Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Dysraphism
Keywords: Spina Bifida
Neurogenic Bladder
Neurogenic Detrusor Overactivity
Detrusor Overactivity
Incontinence
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: Severance Hospital
name: Samsung Medical Center
name: Keimyung University Dongsan Medical Center
name: Pusan National University Yangsan Hospital
First posted: 2023-07-27
Enrollment: 1500
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Primary outcomes:
measure: Achieving full continence at age 5
timeFrame: Age 5
measure: Achieving full continence at age 7
timeFrame: Age 7
measure: Achieving full continence at age 10
timeFrame: Age 10
Secondary outcomes:
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kwanjin Park, MD/PHD
role: STUDY_CHAIR
affiliation: Severance Hospital
name: Sang Woon Kim, MD/PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Sang Hoon Song, MD/PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Minki Baek, MD/PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Yangsan Hospital
name: Jae Min Chung, MD/PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung University Dongsan Medical Center
name: Ji Yong Ha, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References: