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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group: Sacral Nerve Root Magnetic Stimulation + Active Ultrasound Therapy | Experimental | Magnetic stimulation: round coil over S3 foramina, verified by toe twitch. 20 Hz intermittent, 1000 pulses/session, intensity 55%-100% max. Active ultrasound: after saline infusion with pressure monitoring (stop at 40 cmH₂O or discomfort), 1.0 MHz, 1.5-2.0 W/cm², 1000 μs PRP, 1:4 duty cycle, 200 μs pulse duration. Probe moved over suprapubic area, 20 min/session. Both given once daily, 7 days/week for 3 weeks. Stop immediately if pressure >40 cmH₂O or any discomfort. |
|
| Control Group： Sacral Nerve Root Magnetic Stimulation + Sham Ultrasound Therapy | Sham Comparator | Magnetic stimulation: identical to Arm 1. Sham ultrasound: same probe, same interface settings (frequency, intensity display, pulse parameters) but zero output power. Bladder infusion and pressure monitoring same as Arm 1. Probe moved over suprapubic area for 20 min/session. Treatment frequency and duration identical to Arm 1 (once daily, 7 days/week, 3 weeks). Stop if pressure >40 cmH₂O or discomfort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device | Device | Participants receive the intervention assigned to their group 7 days per week for 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bladder capacity at first detrusor overactivity | Measured by urodynamic study. The volume at which involuntary detrusor contraction first occurs during bladder filling. Target safe capacity ≥300 ml. | Baseline and immediately after 3-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Urodynamic parameters-Bladder compliance | reflecting bladder wall elasticity, calculated as the change in bladder volume divided by the change in detrusor pressure, ΔV/ΔP | Baseline and immediately after 3-week intervention |
| Chinese version of the Neurogenic Bladder (NB) Brief Health Survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xue Jiang | Contact | +86 18940254064 | jiangxueruby@163.com | |
| Kaixuan Zhu | Contact | 17860690831 | 2033055053@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xue Jiang | Rehabilitation Center of Shengjing Hospital, China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000 | Shenyang | China |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Experimental group: Sacral nerve root magnetic stimulation + active ultrasound therapy Control group: Sacral nerve root magnetic stimulation + sham ultrasound therapy
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assessing the impact of neurogenic bladder on overall health status and daily living |
| Baseline and immediately after 3-week intervention |
| Voiding diary parameters | Includes single-void volume, urgency score, and incontinence episodes, recorded over at least 72 consecutive hours. | Baseline and after 3-week intervention |
| Urodynamic parameters-First sensation of bladder filling | the infused volume at which the subject first perceives the initial urge to void | Baseline and immediately after 3-week intervention |
| Infection-related indicators-Urine white blood cell (WBC) count | an objective laboratory quantitative indicator of urinary tract infection | Baseline and immediately after 3-week intervention |
| Antibiotic utilization rate | calculated as defined daily doses per treatment cycle, reflecting the frequency of antibiotic intervention due to infection during the treatment period | Baseline and immediately after 3-week intervention |
| Urodynamic parameters-Detrusor leak point pressure | the detrusor pressure at the moment of urinary leakage during storage, reflecting urethral closure reserve | Baseline and immediately after 3-week intervention |
| Urodynamic parameters-Maximum detrusor contraction pressure | the peak detrusor pressure achieved during the voiding phase | Baseline and immediately after 3-week intervention |
| Urodynamic parameters-Duration of detrusor contraction | the total time of sustained effective detrusor contraction during voiding | Baseline and immediately after 3-week intervention |
| Overactive Bladder Symptom Score (OABSS) | quantifying the severity of lower urinary tract symptoms including frequency, urgency, and urgency incontinence | Baseline and immediately after 3-week intervention |
| Voiding difficulty score | assessing subjective symptoms such as straining, weak stream, and hesitancy | Baseline and immediately after 3-week intervention |
| Quality of Life score (QoL) | evaluating the interference of lower urinary tract dysfunction with daily activities, social functioning, and emotional well-being | Baseline and immediately after 3-week intervention |
| Bladder wall thickness | measured by ultrasound, reflecting detrusor hypertrophy or fibrotic changes | Baseline and immediately after 3-week intervention |
| Bladder tissue architecture / morphology | including wall layering clarity, mucosal surface regularity, and internal echogenicity uniformity | Baseline and immediately after 3-week intervention |
| Upper urinary tract dilation, pelvicalyceal system separation, and hydronephrosis | comprehensively assessing the degree of ureteral and pelvicalyceal dilatation as structural indicators of upper urinary tract damage risk | Baseline and immediately after 3-week intervention |
| D014947 | Wounds and Injuries |