Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI

Официальное название

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

Обзор

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?

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Bladder capacity at first detrusor overactivity [Срок оценки: Baseline and immediately after 3-week intervention]

Вторичные конечные точки (12)

• Urodynamic parameters-Bladder compliance [Срок оценки: Baseline and immediately after 3-week intervention]
• Chinese version of the Neurogenic Bladder (NB) Brief Health Survey [Срок оценки: Baseline and immediately after 3-week intervention]
• Voiding diary parameters [Срок оценки: Baseline and after 3-week intervention]
• Urodynamic parameters-First sensation of bladder filling [Срок оценки: Baseline and immediately after 3-week intervention]
• Infection-related indicators-Urine white blood cell (WBC) count [Срок оценки: Baseline and immediately after 3-week intervention]
• Antibiotic utilization rate [Срок оценки: Baseline and immediately after 3-week intervention]
• Urodynamic parameters-Detrusor leak point pressure [Срок оценки: Baseline and immediately after 3-week intervention]
• Urodynamic parameters-Maximum detrusor contraction pressure [Срок оценки: Baseline and immediately after 3-week intervention]
• Urodynamic parameters-Duration of detrusor contraction [Срок оценки: Baseline and immediately after 3-week intervention]
• Overactive Bladder Symptom Score (OABSS) [Срок оценки: Baseline and immediately after 3-week intervention]
• Voiding difficulty score [Срок оценки: Baseline and immediately after 3-week intervention]
• Quality of Life score (QoL) [Срок оценки: Baseline and immediately after 3-week intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning — Шэньян

Идентификаторы

NCT: NCT07704268 · 2026PS1147K

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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