Clinical trial NCT04483570: Urological Deterioration in Secondary Tethered Cord Syndrome and Clue to Detect It
Official title: Urological Deterioration in Secondary Tethered Cord Syndrome and Clue to Detect It
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurogenic Bladder
Tethered Spinal Cord Syndrome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 54
Sex: ALL
Minimum age (years): 3
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with signs of progressive deterioration in urological or neuroorthopedic system, and suspected Secondary Tethered Cord Syndrome (STCS) following primary untethering surgery.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pre-operative evaluation: Dysfunctional voiding
timeFrame: Baseline
measure: Pre-operative evaluation: Presence of Urinary Tract Infection (UTI)
timeFrame: Baseline
measure: VUD (Video Urodynamic Studies)
timeFrame: Baseline
measure: VUD (Video Urodynamic Studies)
timeFrame: 1 year after the operation
measure: VUD (Video Urodynamic Studies)
timeFrame: 2 years after the operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Kwanjin Park, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: