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

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device

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 Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xue Jiang; Phone Number: +86 18940254064; Email: jiangxueruby@163.com
• Study Contact Backup: Name: Kaixuan Zhu; Phone Number: 17860690831; Email: 2033055053@qq.com

Study Locations

• China
  • Shenyang, China
    • Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000
    • Contact: Xue Jiang; Phone Number: +86 189 4025 4064; Email: jiangxueruby@163.com
    • Contact: Kaixuan Zhu; Phone Number: +8617860690831; Email: 2033055053@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device; Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
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.	Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device; Participants receive the intervention assigned to their group 7 days per week for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urodynamic parameters-Bladder compliance	reflecting bladder wall elasticity, calculated as the change in bladder volume divided by the change in detrusor pressure, ΔV/ΔP	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	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.	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	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	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	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	Baseline and immediately after 3-week intervention
Urodynamic parameters-Maximum detrusor contraction pressure	the peak detrusor pressure achieved during the voiding phase	Baseline and immediately after 3-week intervention
Urodynamic parameters-Duration of detrusor contraction	the total time of sustained effective detrusor contraction during voiding	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	Baseline and immediately after 3-week intervention
Voiding difficulty score	assessing subjective symptoms such as straining, weak stream, and hesitancy	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	Baseline and immediately after 3-week intervention
Bladder wall thickness	measured by ultrasound, reflecting detrusor hypertrophy or fibrotic changes	Baseline and immediately after 3-week intervention
Bladder tissue architecture / morphology	including wall layering clarity, mucosal surface regularity, and internal echogenicity uniformity	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	Baseline and immediately after 3-week intervention

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Principal Investigator: Xue Jiang, Rehabilitation Center of Shengjing Hospital, China Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: 2026PS1147K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No