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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Bladder capacity at first detrusor overactivity
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Bladder capacity at first detrusor overactivity
时间窗: 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.
次要结局
- 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)
- Antibiotic utilization rate(Baseline and immediately after 3-week intervention)
- Urodynamic parameters-Detrusor leak point pressure(Baseline and immediately after 3-week intervention)
- Urodynamic parameters-Maximum detrusor contraction pressure(Baseline and immediately after 3-week intervention)
- Urodynamic parameters-Duration of detrusor contraction(Baseline and immediately after 3-week intervention)
- Overactive Bladder Symptom Score (OABSS)(Baseline and immediately after 3-week intervention)
- Voiding difficulty score(Baseline and immediately after 3-week intervention)
- Quality of Life score (QoL)(Baseline and immediately after 3-week intervention)
- Bladder wall thickness(Baseline and immediately after 3-week intervention)
- Bladder tissue architecture / morphology(Baseline and immediately after 3-week intervention)
- Upper urinary tract dilation, pelvicalyceal system separation, and hydronephrosis(Baseline and immediately after 3-week intervention)
研究者
Xue Jiang
Associate Professor
Shengjing Hospital