Neurogenic BladderNCT04483570
Urological Deterioration in Secondary Tethered Cord Syndrome and Clue to Detect It
An observational study of Neurogenic Bladder and Tethered Spinal Cord Syndrome, run by Seoul National University Hospital.
Trial summary
Secondary tethered cord syndrome (STCS) has been diagnosed with signs of progressive deterioration in urological or neuroorthopedic systems following primary tethering surgery. However, there is no convincing urological diagnostic clue for STCS. Read more about this study
- Who is it for?
- Ages 3 months to 23 years
- Conditions the study is for
- Neurogenic Bladder, Tethered Spinal Cord Syndrome
- What is being tested?
- Redo-tethering operation
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2018
- 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 3 months to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with signs of progressive deterioration in urological or neuroorthopedic system, and suspected Secondary Tethered Cord Syndrome (STCS) following primary untethering surgery.
Who may be able to join
- Children with signs of progressive deterioration in urological or neuroorthopedic system following primary untethering surgery.
Who cannot join
- Children without signs of progressive in urological or neuroorthopedic system following primary untethering surgery.
About this study
Secondary tethered cord syndrome (STCS) has been diagnosed with signs of progressive deterioration in urological or neuroorthopedic systems following primary tethering surgery. However, there is no convincing urological diagnostic clue for STCS.
Read the detailed description
Tethered cord syndrome (TCS) refers to various problems involving neurologic, orthopedic, and urologic systems, seen as a result of chronic traction of the spinal cord in patients with spinal dysraphism. Evidence for neural injury is often assumed irreversible, so untethering is justified to maintain neural function and prevent further neural damage. Unfortunately, some patients experienced an aggravation of symptoms following untethering. The probable causes are assumed to be the neural injury before or during operation, which was revealed along with dysplastic neural function, neural compression by increasing syrinx and secondary tethered cord syndrome (STCS) in which postoperative neural adhesion or syrinx limit motion of spinal and elicit ischemic changes as the spine grows during puberty. The Secondary Tethered Cord Syndrome is reported as 19% of cases and causes significant progressive morbidities in those who affected.
Unfortunately, the detection of STCS is not as simple as it thought. Although magnetic resonance imaging (MRI) often reveals that the cord seems to get straightened, this does not necessarily mean that is a significant tethering or cord associated with progressive nerve damage. The variable course of progression and involvement of multiple systems such as lower extremity, bladder, bowel, and back would not allow a single specialist to draw conclusions about the presence of secondary tethered cord syndrome. Moreover, the untethering procedure of STCS may not always be safe and effective. Given the fact that a significant number of 'no improvement' or new onset complications following redo-untethering, the surgery could not be attempted without clear evidence. This explains the reason there is only a limited number of relevant studies so far.
In this study, it aims to delinate the genuine features of secondary tethered cord syndrome by selecting and analyzing only cases with symptom improvements. Furthermore, it described their natural history and time course of urological deterioration and characterized by the urodynamic changes before and after the redo-untethering.
- Conditions
- Neurogenic Bladder, Tethered Spinal Cord Syndrome
- Being tested
- Redo-tethering operation
- Medical subject headings
- Urinary Bladder, Neurogenic, Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redo-tethering operationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Secondary Tethered Cord Syndrome | Children with signs of progressive deterioration in urological or neuroorthopedic system, and suspected Secondary Tethered Cord Syndrome (STCS) following primary untethering surgery. Receives: Procedure: Redo-tethering operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative evaluation: Dysfunctional voiding
Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation.
Measured: Baseline
Pre-operative evaluation: Presence of Urinary Tract Infection (UTI)
Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation
Measured: Baseline
VUD (Video Urodynamic Studies)
Measuring maximal cystometric capacity, compliance, estimated bladder capacity before the operation of the secondary tethered cord syndrome.
Measured: Baseline
VUD (Video Urodynamic Studies)
Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome
Measured: 1 year after the operation
VUD (Video Urodynamic Studies)
Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome
Measured: 2 years after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study startJan 2011
- Primary completionNov 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwanjin Park, Seoul National University Hospital
- Investigators
- Kwanjin Park, MD, PHD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483570
- Sponsor's protocol ID
- H-1809-029-969
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urological Deterioration in Secondary Tethered Cord Syndrome and Clue to Detect It
- ClinicalTrials.gov ID
- NCT04483570
- Acronym / sponsor ID
- H-1809-029-969
- Conditions
- Neurogenic Bladder, Tethered Spinal Cord Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 Jul 2020 (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.
Secondary tethered cord syndrome (STCS) has been diagnosed with signs of progressive deterioration in urological or neuroorthopedic systems following primary tethering surgery. However, there is no convincing urological diagnostic clue for STCS.
Detailed description
Tethered cord syndrome (TCS) refers to various problems involving neurologic, orthopedic, and urologic systems, seen as a result of chronic traction of the spinal cord in patients with spinal dysraphism. Evidence for neural injury is often assumed irreversible, so untethering is justified to maintain neural function and prevent further neural damage. Unfortunately, some patients experienced an aggravation of symptoms following untethering. The probable causes are assumed to be the neural injury before or during operation, which was revealed along with dysplastic neural function, neural compression by increasing syrinx and secondary tethered cord syndrome (STCS) in which postoperative neural adhesion or syrinx limit motion of spinal and elicit ischemic changes as the spine grows during puberty. The Secondary Tethered Cord Syndrome is reported as 19% of cases and causes significant progressive morbidities in those who affected.
Unfortunately, the detection of STCS is not as simple as it thought. Although magnetic resonance imaging (MRI) often reveals that the cord seems to get straightened, this does not necessarily mean that is a significant tethering or cord associated with progressive nerve damage. The variable course of progression and involvement of multiple systems such as lower extremity, bladder, bowel, and back would not allow a single specialist to draw conclusions about the presence of secondary tethered cord syndrome. Moreover, the untethering procedure of STCS may not always be safe and effective. Given the fact that a significant number of 'no improvement' or new onset complications following redo-untethering, the surgery could not be attempted without clear evidence. This explains the reason there is only a limited number of relevant studies so far.
In this study, it aims to delinate the genuine features of secondary tethered cord syndrome by selecting and analyzing only cases with symptom improvements. Furthermore, it described their natural history and time course of urological deterioration and characterized by the urodynamic changes before and after the redo-untethering.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secondary Tethered Cord Syndrome | – | Procedure: Redo-tethering operationChildren with signs of progressive deterioration in urological or neuroorthopedic system, and suspected Secondary Tethered Cord Syndrome (STCS) following primary untethering surgery. |
Who may qualify
- Ages
- 3 months to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with signs of progressive deterioration in urological or neuroorthopedic system, and suspected Secondary Tethered Cord Syndrome (STCS) following primary untethering surgery.
Key inclusion criteria (1 listed)
- Children with signs of progressive deterioration in urological or neuroorthopedic system following primary untethering surgery.
Key exclusion criteria (1 listed)
- Children without signs of progressive in urological or neuroorthopedic system following primary untethering surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Redo-tethering operation | Procedure or surgery | Secondary Tethered Cord Syndrome |
Primary outcome
Pre-operative evaluation: Dysfunctional voiding
Time frame: Baseline
Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation.
Pre-operative evaluation: Presence of Urinary Tract Infection (UTI)
Time frame: Baseline
Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation
VUD (Video Urodynamic Studies)
Time frame: Baseline
Measuring maximal cystometric capacity, compliance, estimated bladder capacity before the operation of the secondary tethered cord syndrome.
VUD (Video Urodynamic Studies)
Time frame: 1 year after the operation
Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome
VUD (Video Urodynamic Studies)
Time frame: 2 years after the operation
Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Individual participant dataSharing planned: No. Not plan to share IPD
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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 principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Bladder and Tethered Spinal Cord Syndrome, run by Seoul National University Hospital.
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: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative evaluation: Dysfunctional voiding (time frame: Baseline). The study lists 5 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 23 Jul 2020.