NCT Number: NCT07695662
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.
Trial opening soon.
Get Notified16 year–80 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Critical missing information in medical records or urodynamic reports
Interval between Modified Ashworth Scale assessment and urodynamic study exceeding 2 weeks
Time frame: Baseline (At hospital admission)
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).
Contact information is provided by the study sponsor or research team.
Siyan Lu
CONTACT
Xue Jiang
CONTACT
Shengjing Hospital
Other
The Predictive Value of Increased Lower Limb Muscle Tone on Neurogenic Detrusor Overactivity in Patients With Spinal Cord Injury: A Retrospective Analysis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07745712
Aquired Brain Injury, Brain Damage, Chronic
Girona, Spain
View Trial DetailsNCT07735676
Brain Diseases, Cardiovascular Diseases
Dhaka, Bangladesh
View Trial DetailsNCT07711015
Central Nervous System Diseases, Nervous System Diseases
Rio de Janeiro, Brazil
View Trial DetailsNCT07639541
Central Nervous System Diseases, Female Urogenital Diseases
Montreal, Quebec, Canada
View Trial Details