Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI
A Randomized, Double-Blind, Sham-Controlled Trial of Sacral Nerve Root High-Frequency Magnetic Stimulation Combined With Ultrasound Therapy for Detrusor Overactivity in Patients With Spinal Cord Injury
1 other identifier
interventional
44
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2026
CompletedStudy Start
First participant enrolled
July 10, 2026
CompletedFirst Posted
Study publicly available on registry
July 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
July 15, 2026
July 1, 2026
10 months
July 6, 2026
July 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (15)
Urodynamic parameters-Bladder compliance
Baseline and immediately after 3-week intervention
Chinese version of the Neurogenic Bladder (NB) Brief Health Survey
Baseline and immediately after 3-week intervention
Voiding diary parameters
Baseline and after 3-week intervention
Urodynamic parameters-First sensation of bladder filling
Baseline and immediately after 3-week intervention
Infection-related indicators-Urine white blood cell (WBC) count
Baseline and immediately after 3-week intervention
- +10 more secondary outcomes
Study Arms (2)
Experimental Group: Sacral Nerve Root Magnetic Stimulation + Active Ultrasound Therapy
EXPERIMENTALMagnetic 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 COMPARATORMagnetic 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.
Interventions
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
Eligibility Criteria
You may qualify if:
- 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;
- Detrusor overactivity confirmed by urodynamic study;
- No severe urinary system diseases such as tumors, stones, infection, or organic urinary tract obstruction;
- No severe hepatic/renal insufficiency, pulmonary, or cardiovascular diseases;
- Aged 18-80 years;
- Able to understand and comply with the required examinations, rehabilitation assessments, and treatment, and provide written informed consent.
You may not qualify if:
- Unstable vital signs or critically ill condition;
- Severe autonomic dysreflexia;
- Presence of metallic implants within 10 cm of the magnetic stimulation treatment area;
- Any other diseases or conditions that may interfere with the study outcomes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000
Shenyang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xue Jiang
Rehabilitation Center of Shengjing Hospital, China Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 6, 2026
First Posted
July 15, 2026
Study Start
July 10, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
July 15, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share