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Not yet recruitingNCT07695662Updated Jul 10, 2026

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

An observational study in Spinal Cord Injuries (SCI), sponsored by Shengjing Hospital. Not yet recruiting. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Shengjing Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
16 Years to 80 Years
Sex
All
01

Study 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.

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Conditions studied

  • Spinal Cord Injuries (SCI)
03

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Critical missing information in medical records or urodynamic reports

Interval between Modified Ashworth Scale assessment and urodynamic study exceeding 2 weeks

04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

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)

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07695662
Lead sponsor
Shengjing Hospital
Responsible party
Xue Jiang (Associate Professor, Shengjing Hospital) — Principal investigator
First posted
Jul 10, 2026
Start date
Jul 7, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 14, 2027 (estimated)
Last update
Jul 10, 2026

Study contacts

Xue Jiang
Contact
jiangxueruby@163.com
+86 18940254064
Siyan Lu
Contact
940436682@qq.com
+86 15998390096
Xue Jiang
principal investigator · Rehabilitation Center of Shengjing Hospital, China Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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