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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-80
SponsorShengjing Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Hypertonia Group
Group B: Normal Tone Group

Trial outcomes

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).

Time frame
Baseline (At hospital admission)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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