Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI

N/ANot Yet RecruitingNCT07704268

Shengjing Hospital44 enrolled

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?

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.