An interventional study of Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device in Spinal Cord Injuries, sponsored by Shengjing Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Shengjing Hospital · Not applicable, Interventional, and Treatment
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 44 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Shengjing Hospital is the lead sponsor of 127 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
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.
Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
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.
Time frame: Baseline and immediately after 3-week intervention
Urodynamic parameters-Bladder compliance
reflecting bladder wall elasticity, calculated as the change in bladder volume divided by the change in detrusor pressure, ΔV/ΔP
Time frame: Baseline and immediately after 3-week intervention
Chinese version of the Neurogenic Bladder (NB) Brief Health Survey
assessing the impact of neurogenic bladder on overall health status and daily living
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and immediately after 3-week intervention
Urodynamic parameters-Maximum detrusor contraction pressure
the peak detrusor pressure achieved during the voiding phase
Time frame: Baseline and immediately after 3-week intervention
Urodynamic parameters-Duration of detrusor contraction
the total time of sustained effective detrusor contraction during voiding
Time frame: 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
Time frame: Baseline and immediately after 3-week intervention
Voiding difficulty score
assessing subjective symptoms such as straining, weak stream, and hesitancy
Time frame: 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
Time frame: Baseline and immediately after 3-week intervention
Bladder wall thickness
measured by ultrasound, reflecting detrusor hypertrophy or fibrotic changes
Time frame: Baseline and immediately after 3-week intervention
Bladder tissue architecture / morphology
including wall layering clarity, mucosal surface regularity, and internal echogenicity uniformity
Time frame: 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
Time frame: Baseline and immediately after 3-week intervention
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Apr 2027, 9 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 9 months is below that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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