The Predictive Value of Lower Extremity Hypertonia on Neurogenic Detrusor Overactivity After Spinal Cord Injury

NCT07695662 | Not Yet Recruiting

• 1 other identifier: 2026PS1154K
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to evaluate whether increased lower extremity muscle tone can serve as an independent predictor of neurogenic detrusor overactivity (NDO) in adult patients (aged 18-80 years) with upper sacral spinal cord injury . The main questions it aims to answer are: Is increased lower extremity muscle tone independently associated with the presence of detrusor overactivity after adjusting for age, sex, injury level, injury type, and injury cause? Does the predictive value of muscle tone for detrusor overactivity differ across subgroups defined by injury level, injury severity, and time since injury? Researchers will compare patients with lower extremity hypertonia (Modified Ashworth Scale ≥ 1) to patients with normal muscle tone (Modified Ashworth Scale = 0) to see if muscle tone elevation independently predicts detrusor overactivity. Participants will not be asked to do anything beyond their routine clinical care, as this is a retrospective study that only collects data from existing medical records, including neurological examination results, Modified Ashworth Scale scores, and urodynamic study reports.

Conditions

Spinal Cord Injuries (SCI)

Outcome Measures

Primary Outcomes (1)

• Presence of Neurogenic Detrusor Overactivity Confirmed by Urodynamic Study

  Neurogenic detrusor overactivity (NDO) is defined as the presence of involuntary detrusor contractions during the filling phase of a urodynamic study, according to International Continence Society (ICS) standards. Urodynamic studies were performed as part of routine clinical care during the hospital admission. This outcome measures the presence or absence of NDO based on the urodynamic report. The result is reported as a binary outcome (present/absent).

  Baseline (At hospital admission)

Study Arms (2)

Hypertonia Group

Patients with lower extremity hypertonia, defined as a Modified Ashworth Scale (MAS) score of 1 or higher at admission.

Normal Tone Group

Patients with normal lower extremity muscle tone, defined as a Modified Ashworth Scale (MAS) score of 0 at admission.

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study looks at adults aged 18 to 80 with suprasacral Spinal Cord Injury who stayed at the Shengjing Hospital of China Medical University from January 2020 to January 2025. All participants have full medical records, including neurological exams, Modified Ashworth Scale checks, and urodynamic test results. Anyone missing key data or with assessments spaced out by more than two weeks was left out.

You may qualify if:

• Diagnosis of spinal cord injury confirmed by CT or MRI imaging
• Suprasacral spinal cord injury according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI, 2011 revision)
• Age between 18 and 80 years
• Complete medical records, including detailed neurological examination, Modified Ashworth Scale assessment, and urodynamic study report

You may not qualify if:

• Critical missing information in medical records or urodynamic reports
• Interval between Modified Ashworth Scale assessment and urodynamic study exceeding 2 weeks

Sponsors & Collaborators

• Shengjing Hospital: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Xue Jiang

  Rehabilitation Center of Shengjing Hospital, China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xue Jiang

CONTACT

+86 18940254064; jiangxueruby@163.com

Siyan Lu

CONTACT

+86 15998390096; 940436682@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 14, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share