RecruitingNCT07704268ClinicalTrials.gov record

Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI

Spinal Cord Injuries

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - 80 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 44 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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?

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Double masked

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.

Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device

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.

Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device

Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device DEVICE

Participants receive the intervention assigned to their group 7 days per week for 3 weeks.

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