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

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.

Study Overview

• Status: Completed
• Conditions: Neurogenic Bladder; Tethered Spinal Cord Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 54

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 23 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-operative evaluation: Dysfunctional voiding	Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation.	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	Baseline
VUD (Video Urodynamic Studies)	Measuring maximal cystometric capacity, compliance, estimated bladder capacity before the operation of the secondary tethered cord syndrome.	Baseline
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2011
• Primary Completion (ACTUAL): November 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (ACTUAL): July 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Wounds and Injuries; Disease; Congenital Abnormalities; Trauma, Nervous System; Spinal Cord Diseases; Nervous System Malformations; Syndrome; Spinal Cord Injuries; Urinary Bladder, Neurogenic; Neural Tube Defects
• Other Study ID Numbers: H-1809-029-969

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No