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

Neurogenic Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483570
• Other study ID #: H-1809-029-969
• Status: Completed
• Start date: January 2011
• Est. completion date: December 2018

Study information

• Verified date: July 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 23 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neural Tube Defects
• Neurogenic Bladder
• Spinal Cord Injuries
• Syndrome
• Tethered Spinal Cord Syndrome
• Urinary Bladder, Neurogenic

Intervention

Procedure:
• Redo-tethering operation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-operative evaluation: Dysfunctional voiding	Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation.	Baseline
Primary	Pre-operative evaluation: Presence of Urinary Tract Infection (UTI)	Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation	Baseline
Primary	VUD (Video Urodynamic Studies)	Measuring maximal cystometric capacity, compliance, estimated bladder capacity before the operation of the secondary tethered cord syndrome.	Baseline
Primary	VUD (Video Urodynamic Studies)	Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome	1 year after the operation
Primary	VUD (Video Urodynamic Studies)	Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome	2 years after the operation