Urological Deterioration in Secondary Tethered Cord Syndrome and Clue to Detect It

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04483570
Collaborator
(none)
54
95

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Redo-tethering operation

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

Study Type:
Observational
Actual Enrollment :
54 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Urological Deterioration in Secondary Tethered Cord Syndrome and Clue to Detect It
Actual Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: Redo-tethering operation

Outcome Measures

Primary Outcome Measures

  1. Pre-operative evaluation: Dysfunctional voiding [Baseline]

    Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation.

  2. Pre-operative evaluation: Presence of Urinary Tract Infection (UTI) [Baseline]

    Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation

  3. VUD (Video Urodynamic Studies) [Baseline]

    Measuring maximal cystometric capacity, compliance, estimated bladder capacity before the operation of the secondary tethered cord syndrome.

  4. VUD (Video Urodynamic Studies) [1 year after the operation]

    Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome

  5. VUD (Video Urodynamic Studies) [2 years after the operation]

    Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 23 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Children with signs of progressive deterioration in urological or neuroorthopedic system following primary untethering surgery.
Exclusion Criteria:
  • Children without signs of progressive in urological or neuroorthopedic system following primary untethering surgery.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: Kwanjin Park, MD, PHD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kwanjin Park, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04483570
Other Study ID Numbers:
  • H-1809-029-969
First Posted:
Jul 23, 2020
Last Update Posted:
Jul 23, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 23, 2020