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Not yet recruiting NCT07704268

Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI

No phase Interventional Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

  • Bladder capacity at first detrusor overactivity [Time frame: Baseline and immediately after 3-week intervention]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning — Shenyang

Identifiers

NCT: NCT07704268 · 2026PS1147K

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗