Spinal DysraphismNCT05962086
Determining Developmental and Clinical Markers Affecting Urinary Function of Children With Spinal Dysraphism
An observational study of Spinal Dysraphism, run by Seoul National University Hospital at 6 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Spinal Dysraphism
- How many people
- 1,500 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 22 Oct 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- Those who received spinal dysraphism diagnosis (ICD Code: Q05.1-05.9) and have been following up and receiving treatments due to neurogenic bladder.
Who cannot join
- As the study is a retrospective study, there is no exclusion criteria.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
Keimyung University Dongsan Medical Center
Daegu
Ji Yong Ha, MD/PHD, urovision1978@gmail.com
Ji Yong Ha, MD/PH
- Recruiting
Asan Medical Center
Seoul
Sang Hoon Song, MD/PHD, mdexodus@amc.seoul.kr
Sang Hoon Song, MD/PHD
- Recruiting
Samsung Medical Center
Seoul
Minki Baek, MD/PHD, drminkibaek@gmail.com
Minki Baek, MD/PHD
- Recruiting
Seoul National University Hospital
Seoul
Kwanjin Park, MD/PHD, urodori9@snu.ac.kr
Kwanjin Park, MD/PHD
- Recruiting
Yonsei University Severance Hospital
Seoul
Sang Woon Kim, MD/PHD, khisin@yuhs.ac
Sang Woon Kim, MD/PHD
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do
Jae Min Chung, MD/PHD, busanuro@hanmail.net
Jae Min Chung, MD/PHD
About this study
Official title: Determining Developmental and Clinical Markers Affecting Urinary Function of Children With Spinal Dysraphism: A Multicenter, Retrospective Cohort
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.
Read the 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.
- Conditions
- Spinal Dysraphism
- Keywords
- Spina Bifida, Neurogenic Bladder, Neurogenic Detrusor Overactivity, Detrusor Overactivity, Incontinence
- Medical subject headings
- Spinal Dysraphism, Urinary Bladder, Neurogenic, Urinary Bladder, Overactive
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving full continence at age 5
Achieving full urinary and fecal continence at age 5
Measured: Age 5
Achieving full continence at age 7
Achieving full urinary and fecal continence at age 7.
Measured: Age 7
Achieving full continence at age 10
Achieving full urinary and fecal continence at age 10
Measured: Age 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start22 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DysraphismStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Severance Hospital, Samsung Medical Center, Keimyung University Dongsan Medical Center, Pusan National University Yangsan Hospital
- Responsible party
- Principal investigator, Kwanjin Park, Seoul National University Hospital
- Investigators
- Kwanjin Park, MD/PHD, Study chair, Seoul National University HospitalSang Woon Kim, MD/PHD, Principal investigator, Severance HospitalSang Hoon Song, MD/PHD, Principal investigator, Asan Medical CenterMinki Baek, MD/PHD, Principal investigator, Samsung Medical CenterJae Min Chung, MD/PHD, Principal investigator, Pusan National University Yangsan HospitalJi Yong Ha, MD/PHD, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962086
- Sponsor's protocol ID
- 2210-092-1369
- Status last verified
- Jul 2023
- First submitted
- 10 Jun 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not willing to share individual participant data (IPD) for this particular study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Developmental and Clinical Markers Affecting Urinary Function of Children With Spinal Dysraphism: A Multicenter, Retrospective Cohort
- ClinicalTrials.gov ID
- NCT05962086
- Acronym / sponsor ID
- 2210-092-1369
- Conditions
- Spinal Dysraphism
- Keywords
- Spina Bifida, Neurogenic Bladder, Neurogenic Detrusor Overactivity, Detrusor Overactivity, Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Asan Medical Center, Severance Hospital, Samsung Medical Center, Keimyung University Dongsan Medical Center, Pusan National University Yangsan Hospital
- Study start
- 22 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Those who received spinal dysraphism diagnosis (ICD Code: Q05.1-05.9) and have been following up and receiving treatments due to neurogenic bladder.
Key exclusion criteria (1 listed)
- As the study is a retrospective study, there is no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Achieving full continence at age 5
Time frame: Age 5
Achieving full urinary and fecal continence at age 5
Achieving full continence at age 7
Time frame: Age 7
Achieving full urinary and fecal continence at age 7.
Achieving full continence at age 10
Time frame: Age 10
Achieving full urinary and fecal continence at age 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No. Not willing to share individual participant data (IPD) for this particular study.
Related trials for Spinal Dysraphism
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
RecruitingObservational study
First-Trimester Screening of Open Neural Tube Defects Using Biometrics and Maternal Serum Markers
Neural Tube Defects (NTDs)
Active, not recruitingPhase 1
Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study
Neural Tube Defects
Not yet recruiting
Motor Imagery-Supported Thoracic Expansion in Children With Spina Bifida
Spina Bifida
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwanjin Park, MD/PHD study chair
Seoul National University Hospital
Sang Woon Kim, MD/PHD principal investigator
Severance Hospital
Sang Hoon Song, MD/PHD principal investigator
Asan Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Dysraphism, run by Seoul National University Hospital at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwanjin Park, MD/PHD (+82-2-2072-0695, urodori9@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieving full continence at age 5 (time frame: Age 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.