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RecruitingNCT05962086Updated Jul 27, 2023

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

An observational study in Spinal Dysraphism, sponsored by Seoul National University Hospital. Recruiting at 6 sites in Korea, Republic of. Open to participants aged Up to 10 Years. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Seoul National University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Oct 2022; still recruiting 4 years later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,500
Ages
Up to 10 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Spinal Dysraphism

Keywords

  • Spina Bifida
  • Neurogenic Bladder
  • Neurogenic Detrusor Overactivity
  • Detrusor Overactivity
  • Incontinence
03

In context

Spinal Dysraphism

142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 105 across 48 observational studies indexed under Spinal Dysraphism.

Browse Spinal Dysraphism studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • As the study is a retrospective study, there is no exclusion criteria.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Achieving full continence at age 5

    Achieving full urinary and fecal continence at age 5

    Time frame: Age 5

  2. Achieving full continence at age 7

    Achieving full urinary and fecal continence at age 7.

    Time frame: Age 7

  3. Achieving full continence at age 10

    Achieving full urinary and fecal continence at age 10

    Time frame: Age 10

07

Study locations

6 of 6 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Not willing to share individual participant data (IPD) for this particular study.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2022 (actual). Primary completion is estimated for Dec 2024, 26 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2023
First posted
Jul 27, 2023
StartActual
Oct 22, 2022
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Jul 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05962086
Collaborators
Asan Medical Center, Severance Hospital, Samsung Medical Center, Keimyung University Dongsan Medical Center, Pusan National University Yangsan Hospital
Responsible party
Kwanjin Park (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jul 27, 2023
Start date
Oct 22, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 27, 2023

Study contacts

Kwanjin Park, MD/PHD
Contact
urodori9@snu.ac.kr
+82-2-2072-0695
Louis Kim, BS
Contact
kim.hyunkyu11@gmail.com
+82-10-4201-0636
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
Minki Baek, MD/PHD
principal investigator · Samsung Medical Center
Jae Min Chung, MD/PHD
principal investigator · Pusan National University Yangsan Hospital
Ji Yong Ha, MD/PHD
principal investigator · Keimyung University Dongsan Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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