Spinal Cord InjuriesNCT07704268
Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI
A study testing Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device in people with Spinal Cord Injuries, run by Shengjing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000
Shenyang
Xue Jiang, +86 189 4025 4064, jiangxueruby@163.com
Kaixuan Zhu, +8617860690831, 2033055053@qq.com
About this study
Official title: 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
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?
Read more
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 detailed 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy deviceDevice
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device |
| 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. Receives: Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after 3-week intervention
Secondary outcomes (15)
Urodynamic parameters-Bladder compliance
reflecting bladder wall elasticity, calculated as the change in bladder volume divided by the change in detrusor pressure, ΔV/ΔP
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and immediately after 3-week intervention
Urodynamic parameters-Maximum detrusor contraction pressure
the peak detrusor pressure achieved during the voiding phase
Measured: Baseline and immediately after 3-week intervention
Urodynamic parameters-Duration of detrusor contraction
the total time of sustained effective detrusor contraction during voiding
Measured: 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
Measured: Baseline and immediately after 3-week intervention
Voiding difficulty score
assessing subjective symptoms such as straining, weak stream, and hesitancy
Measured: 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
Measured: Baseline and immediately after 3-week intervention
Bladder wall thickness
measured by ultrasound, reflecting detrusor hypertrophy or fibrotic changes
Measured: Baseline and immediately after 3-week intervention
Bladder tissue architecture / morphology
including wall layering clarity, mucosal surface regularity, and internal echogenicity uniformity
Measured: 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
Measured: Baseline and immediately after 3-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: Sacral nerve root magnetic stimulation + active ultrasound therapy Control group: Sacral nerve root magnetic stimulation + sham ultrasound therapy
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Jiang, Shengjing Hospital
- Investigators
- Xue Jiang, Principal investigator, Rehabilitation Center of Shengjing Hospital, China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704268
- Sponsor's protocol ID
- 2026PS1147K
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07704268
- Acronym / sponsor ID
- 2026PS1147K
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group: Sacral nerve root magnetic stimulation + active ultrasound therapy Control group: Sacral nerve root magnetic stimulation + sham ultrasound therapy
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Sacral Nerve Root Magnetic Stimulation + Active Ultrasound Therapy | Experimental | Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy deviceMagnetic 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 | Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy deviceMagnetic 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy deviceParticipants receive the intervention assigned to their group 7 days per week for 3 weeks. | Device | Control Group： Sacral Nerve Root Magnetic Stimulation + Sham Ultrasound Therapy, Experimental Group: Sacral Nerve Root Magnetic Stimulation + Active Ultrasound Therapy |
Primary outcome
Bladder capacity at first detrusor overactivity
Time frame: Baseline and immediately after 3-week intervention
Measured by urodynamic study. The volume at which involuntary detrusor contraction first occurs during bladder filling. Target safe capacity ≥300 ml.
15 secondary outcomes
Urodynamic parameters-Bladder compliance
Time frame: Baseline and immediately after 3-week intervention
Chinese version of the Neurogenic Bladder (NB) Brief Health Survey
Time frame: Baseline and immediately after 3-week intervention
Voiding diary parameters
Time frame: Baseline and after 3-week intervention
Urodynamic parameters-First sensation of bladder filling
Time frame: Baseline and immediately after 3-week intervention
Infection-related indicators-Urine white blood cell (WBC) count
Time frame: Baseline and immediately after 3-week intervention
Antibiotic utilization rate
Time frame: Baseline and immediately after 3-week intervention
Urodynamic parameters-Detrusor leak point pressure
Time frame: Baseline and immediately after 3-week intervention
Urodynamic parameters-Maximum detrusor contraction pressure
Time frame: Baseline and immediately after 3-week intervention
Urodynamic parameters-Duration of detrusor contraction
Time frame: Baseline and immediately after 3-week intervention
Overactive Bladder Symptom Score (OABSS)
Time frame: Baseline and immediately after 3-week intervention
Voiding difficulty score
Time frame: Baseline and immediately after 3-week intervention
Quality of Life score (QoL)
Time frame: Baseline and immediately after 3-week intervention
Bladder wall thickness
Time frame: Baseline and immediately after 3-week intervention
Bladder tissue architecture / morphology
Time frame: Baseline and immediately after 3-week intervention
Upper urinary tract dilation, pelvicalyceal system separation, and hydronephrosis
Time frame: Baseline and immediately after 3-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xue Jiang principal investigator
Rehabilitation Center of Shengjing Hospital, China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device in people with Spinal Cord Injuries, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue Jiang (+86 18940254064, jiangxueruby@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder capacity at first detrusor overactivity (time frame: Baseline and immediately after 3-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.