Spinal Cord Injuries
Conditions
Brief summary
This clinical trial aims to investigate whether the combination of high-frequency sacral nerve root magnetic stimulation and bladder-directed ultrasound therapy can effectively improve detrusor overactivity (involuntary bladder contractions) and related voiding dysfunctions in patients with spinal cord injury. The main questions it seeks to answer are: What is the effect of high-frequency sacral nerve root magnetic stimulation on detrusor overactivity and bladder function in patients with spinal cord injury? What is the effect of bladder-directed ultrasound therapy on detrusor overactivity and bladder wall compliance in patients with spinal cord injury? Is the combination of these two treatment modalities superior to magnetic stimulation alone?
Detailed description
Researchers will combine high-frequency sacral nerve root magnetic stimulation with bladder ultrasound therapy and compare this combination against magnetic stimulation alone (with sham ultrasound) to determine whether the combined approach provides added benefit. Participants will: Receive either sacral nerve root magnetic stimulation, bladder ultrasound therapy, or the combination of both, once daily for 3 consecutive weeks (7 sessions per week). Attend the hospital for urodynamic testing (to assess safe bladder capacity, storage pressure, and compliance) and urinary tract ultrasound (to evaluate bladder wall thickness and upper urinary tract structure) before the treatment and after the 3-week intervention. Maintain a voiding diary for at least 3 consecutive days (recording single voided volumes, urgency scores, and incontinence episodes), and complete validated questionnaires on lower urinary tract symptoms and quality of life.
Interventions
DEVICETranscranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
Sponsors
Shengjing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Experimental group: Sacral nerve root magnetic stimulation + active ultrasound therapy Control group: Sacral nerve root magnetic stimulation + sham ultrasound therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of spinal cord injury (SCI) above the sacral level according to the International Standards for Neurological Classification of Spinal Cord Injury (revised 2011), confirmed by CT or MRI; 2. Detrusor overactivity confirmed by urodynamic study; 3. No severe urinary system diseases such as tumors, stones, infection, or organic urinary tract obstruction; 4. No severe hepatic/renal insufficiency, pulmonary, or cardiovascular diseases; 5. Aged 18-80 years; 6. Able to understand and comply with the required examinations, rehabilitation assessments, and treatment, and provide written informed consent.
Exclusion criteria
1. Unstable vital signs or critically ill condition; 2. Severe autonomic dysreflexia; 3. Presence of metallic implants within 10 cm of the magnetic stimulation treatment area; 4. Any other diseases or conditions that may interfere with the study outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bladder capacity at first detrusor overactivity | Baseline and immediately after 3-week intervention | Measured by urodynamic study. The volume at which involuntary detrusor contraction first occurs during bladder filling. Target safe capacity ≥300 ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urodynamic parameters-Bladder compliance | Baseline and immediately after 3-week intervention | reflecting bladder wall elasticity, calculated as the change in bladder volume divided by the change in detrusor pressure, ΔV/ΔP |
| Chinese version of the Neurogenic Bladder (NB) Brief Health Survey | Baseline and immediately after 3-week intervention | assessing the impact of neurogenic bladder on overall health status and daily living |
| Voiding diary parameters | Baseline and after 3-week intervention | Includes single-void volume, urgency score, and incontinence episodes, recorded over at least 72 consecutive hours. |
| Urodynamic parameters-First sensation of bladder filling | Baseline and immediately after 3-week intervention | the infused volume at which the subject first perceives the initial urge to void |
| Infection-related indicators-Urine white blood cell (WBC) count | Baseline and immediately after 3-week intervention | an objective laboratory quantitative indicator of urinary tract infection |
| Antibiotic utilization rate | Baseline and immediately after 3-week intervention | calculated as defined daily doses per treatment cycle, reflecting the frequency of antibiotic intervention due to infection during the treatment period |
| Urodynamic parameters-Detrusor leak point pressure | Baseline and immediately after 3-week intervention | the detrusor pressure at the moment of urinary leakage during storage, reflecting urethral closure reserve |
| Urodynamic parameters-Maximum detrusor contraction pressure | Baseline and immediately after 3-week intervention | the peak detrusor pressure achieved during the voiding phase |
| Urodynamic parameters-Duration of detrusor contraction | Baseline and immediately after 3-week intervention | the total time of sustained effective detrusor contraction during voiding |
| Overactive Bladder Symptom Score (OABSS) | Baseline and immediately after 3-week intervention | quantifying the severity of lower urinary tract symptoms including frequency, urgency, and urgency incontinence |
| Voiding difficulty score | Baseline and immediately after 3-week intervention | assessing subjective symptoms such as straining, weak stream, and hesitancy |
| Quality of Life score (QoL) | Baseline and immediately after 3-week intervention | evaluating the interference of lower urinary tract dysfunction with daily activities, social functioning, and emotional well-being |
| Bladder wall thickness | Baseline and immediately after 3-week intervention | measured by ultrasound, reflecting detrusor hypertrophy or fibrotic changes |
| Bladder tissue architecture / morphology | Baseline and immediately after 3-week intervention | including wall layering clarity, mucosal surface regularity, and internal echogenicity uniformity |
| Upper urinary tract dilation, pelvicalyceal system separation, and hydronephrosis | Baseline and immediately after 3-week intervention | comprehensively assessing the degree of ureteral and pelvicalyceal dilatation as structural indicators of upper urinary tract damage risk |
Countries
China
Contacts
CONTACTXue Jiang
CONTACTKaixuan Zhu
PRINCIPAL_INVESTIGATORXue Jiang
Rehabilitation Center of Shengjing Hospital, China Medical University
Outcome results
None listed