Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI

Sponsor
Shengjing Hospital
Study ID
NCT07704268
Status
Not Yet Recruiting

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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device — DEVICE
    Participants receive the intervention assigned to their group 7 days per week for 3 weeks.

Study Details

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?

Key Dates

First listed
Jul 15, 2026
Start date
Jul 10, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group: Sacral Nerve Root Magnetic Stimulation + Active Ultrasound Therapy
    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.
  • Sham Comparator: Control Group： Sacral Nerve Root Magnetic Stimulation + Sham Ultrasound Therapy
    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.

Primary Outcome Measure

Bladder capacity at first detrusor overactivity [ Time Frame: Baseline and immediately after 3-week intervention ]

Central Contacts

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